Search Results for "Sclerotherapy and Vein Treatments"
Does the Relative Silicone Content of Different Syringes Affect the Stability of Foam in Sclerotherapy?
Stephanie W. Lai MD, Mitchel P. Goldman MD| |
Background: Sclerotherapy has become the gold standard in the treatment of varicose veins. Foam sclerosing solution with sodium tetradecyl sulfate (STS) is one of the most popular agents used. This study examined the possibility that relative silicone content of different syringes may affect the overall foam stability.
Materials and Methods: A double-syringe system (DSS) technique to make sclerosing foam (STS 0.5% and air) was applied. Four different brands of syringes were tested. The time required for half of the original volume of sclerosing solution to settle was recorded.
Results: The time for the sclerosing solution to settle to half of its initial volume varied with each brand of syringes.
Conclusion: The type of syringe used in the DSS technique to produce foam for sclerotherapy is a determinant of foam stability. Whether this will affect the result of sclerotherapy requires further investigation.
Monopolar Radiofrequency Facial Tightening: A Retrospective Analysis of Efficacy and Safety in Over 600 Treatments
Robert A. Weiss MD, Margaret A. Weiss MD, Girish Munavalli MD MHS, Karen L. Beasley MD| |
Study Design: Charts and clinical images of over 600 consecutive patient treatments between May 2002 and June 2006 using a monopolar radiofrequency device (Thermacool®, Thermage, Haywood, CA) for skin tightening at the Maryland Laser, Skin and Vein Institute were retrospectively reviewed. The primary presentation for treatment was skin laxity of the lower face. Treatment was delivered with a 1-cm2 standard tip at fluences of 81 to 124 J/cm2 (level of 12.5 to 15), a 1-cm2 “fast” tip at fluences of 62 to 109 J/cm2 (level of 72.0 to 76.0), a 1.5-cm2 “big fast” tip at fluences of 75 to 130 J/cm2 (level of 61.5 to 65), and a 3-cm2 “bigger” tip at equivalent fluences as each became available. As treatment algorithms evolved over 4 years, the algorithm of multiple passes at lower fluence associated with better clinical outcomes and greater patient acceptance has been adopted.
Conclusions: Our data, obtained in an office setting without injectable anesthetic or IV sedation, indicate that monopolar RF for skin tightening is ver safe procedure. The treatment algorithm and tips have evolved over several years leading to increased safety and efficacy. Side effects are infrequent, self-limited, and minor, comparing favorably to other nonablative devices utilized for facial rejuvenation.
Robert A. Weiss, MD and Margaret A. Weiss, MD| |
Cutaneous Lupus Erythematosus in a Patient Undergoing Intravitreal Bevacizumab Injections: Case Report and Review of the Literature
Nathan Cleaver DO,a James Ramirez MD,b and Stuart Gildenberg MDa| |
CASE PRESENTATION: We report a case of a 63 year-old Caucasian female who presented with subacute cutaneous lupus erythematosus six weeks after initiating two intravitreal injections of bevacizumab for central serous choroidopathy.
CONCLUSION: We report the first documented case of a cutaneous lupus erythematosus eruption following bevacizumab administration as a monotherapy.
J Drugs Dermatol. 2013;12(9):1052-1055.
David L. Chen MDa and Joel L. Cohen MDa,b| |
J Drugs Dermatol. 2015;14(11):1360-1362.
Molly Wanner MD MBA, Mathew Avram MD JD| |
Kenneth R. Beer MD FAAD,a Stephanie Bayers BSBA,b and Jacob Beerc| |
J Drugs Dermatol. 2014;13(suppl 1):s17-s20.
Shannon Famenini MD and Carolyn Goh MD| |
J Drugs Dermatol. 2014;13(7):809-812.
Navid Bouzari MD, Keyvan Nouri MD, Hossein Tabatabai MD, Zahra Abbasi MD, Alireza Firooz MD, Yahya Dowlati MD PhD| |
Methods: A retrospective study of 313 consecutive laser-assisted hair removal treatments was conducted on a total of 23 patients (22 women, 1 man) with 58 anatomic areas by means of an alexandrite laser. Skin types of III and IV were represented. The long-pulsed alexandrite system (Aphrodite, Quanta system, Italy) was used at a 755-nm wavelength to deliver fluences ranging from 17 to 25 j/cm2 through a 10 mm spot size. The patients were divided into 4 groups according to the number of treatments (group I ? 4, group II = 5, group III = 6, and group IV ? 7 treatments). Digital photographs of the patients were used for hair counting. Adverse effects (hyperpigmentation, hypopigmentation, blister, folliculitis) were questioned. The treatment was defined as successful if there was more than 50% hair reduction and an absence of the adverse effects.
Results: There was a positive correlation between hair reduction and number of treatments (r = .402, p < .005). The following side effects were observed: hyperpigmentation (two patients, both in group IV); hypopigmentation (one patient in group IV) and blister (one patient in group IV); folliculitis (two patients in group III and IV). Treatment was successful in 48.3% (28 out of 58) of the treatment sites. The success rate was 25% for ?4 treatments, and 76%, 58%, and 15% for 5, 6, and ?7 treatments respectively (p = .002).
Conclusion: Patients who undergo more treatment sessions achieve a higher rate of hair reduction; although this may be concomitant with an increase in the incidence of adverse effects. The benefit of more laser treatments should be balanced with the risk of occurrence of side effects in each patient.
A New Approach to Comparing Efficacy Results from Clinical Trials of Topical Acne Vulgaris Treatments
Joseph Bikowski MD FAAD| |
David J. Goldberg MD, Snehal Amin MD, Bruce A. Russell MD, Robert Phelps MD, Norma Kellett MD, Laurence A. Reilly MD| |
Gabriella DiMarco MDa and Amy McMichael MDb| |
INTRODUCTION: Hair loss is a common complaint seen in dermatology clinics. From frustration and attempts at self-help, patients with hair loss may present to the dermatologist with false beliefs, or myths, about the causes of their condition and what treatments are effective.
METHODS: We identified 12 common myths about hair loss, categorized as myths about minoxidil treatment, vitamin and mineral supplements, natural topical treatments, and hair care practices. We performed a PubMed search to find evidence to support or refute each myth.
RESULTS: We found that there is little evidence to support many of these common hair loss myths. In some cases, randomized controlled trials have investigated the effects of particular therapies and point to the effectiveness of certain hair loss treatments.
DISCUSSION: In many cases, there have not been sufficient randomized controlled trials to evaluate the effect of different therapies and hair care practices on hair loss. It is best to guide patients toward treatments with a long track record of efficacy and away from those where little is known scientifically.
J Drugs Dermatol. 2017;16(7):690-694.
Amy Forman Taub MD| |
Calcium Hydroxylapatite for Augmentation of Face and Hands: A Retrospective Analysis in Italian Subjects
Gabriele F. Muti MD,a Giorgio Astolfi MD,b Massimo Renzi MD,c and Pier P. Rovatti MDd| |
J Drugs Dermatol. 2015;14(9):948-954.
Leon H. Kircik MD| |
Increased understanding of psoriasis has led to a shift in treatments from non-specific immunosuppressants to targeted biologics. Studies in psoriasis have demonstrated minimal risk and substantial benefit. As a result, dermatologists and patients are more frequently choosing biologics as first-line treatments for moderate-to-severe disease as our biologics options have recently increased.
Christopher I. Zoumalan MD FACS| |
J Drugs Dermatol. 2018;17(4):421-425.
Ross M. Campbell MD, Christopher B. Harmon MD| |
Aditya K. Gupta MD PhD FAAD FRCP(C), Michael Uro DPM, Elizabeth A. Cooper BESc HBSc| |
Psoriasis and Psoriatic Arthritis in a Patient with HIV: Response to Mycophenolate Mofetil Treatment
Seth B. Forman MD, Robert Higginson PA-C, Algin B. Garrett MD| |
Treatment Patterns and Perceptions of Treatment Attributes, Satisfaction and Effectiveness Among Patients With Psoriasis
Marco daCosta DiBonaventura PhD, Samuel Wagner PhD RP, Heidi C. Waters MS, MBA, Chureen Carter PharmD, MS| |
The Erbium Micropeel: A Prospective, Randomized Trial of the Effects of Two Fluence Settings on Facial Photoaging
Brian Somoano MD, Basil M. Hantash MD PhD, Edgar F. Fincher MD PhD, Peggy Wu MD, Hayes B. Gladstone MD| |
Methods: Forty-six subjects with mild-to-moderate facial dyschromia and rhytides were evenly randomized to two Er:YAG treatment arms. Patients in the lower fluence (LF) (2.5 J/cm2) and higher fluence (HF) (3.8 J/cm2) groups each received three one-pass, full-face treatments one month apart. Patient and investigator assessments of rhytides, dyschromia and global appearance were performed at baseline and at four, eight and 20 weeks using a nominal scale from 1–4. Adverse events and patient satisfaction were also evaluated.
Results: Patient scores showed rhytid improvement only with HF treatments. Investigator scores at three months post-treatment showed dyschromia was significantly improved in both study arms, with a 24 and 36 percent reduction for the LF and HF groups, respectively. Global appearance scores improved by 25 and 32 percent, respectively. A trend towards greater post-procedure erythema and time-to-erythema resolution was observed in the HF group. Mild peeling was the most common adverse event. Individuals who underwent LF treatments were more likely to pursue future treatments.
Conclusion: Both settings resulted in moderate but significant improvement in dyschromia, although only HF treatment improved rhytides. The decreased downtime of LF treatments made this the preferred choice of patients.
J Drugs Dermatol. 2011;10(2):179-176.
Mark A. Strom BS,a Girish C. Mohan MD,b and Peter A. Lio MDa| |
J Drugs Dermatol. 2016;15(10):1203-1207.
Reductions in Thigh and Infraumbilical Circumference Following Treatment With a Novel Device Combining Ultrasound, Suction, and Massage
K. Wade Foster MD PhD, David J. Kouba MD PhD, Jennifer Hayes, Valerie Freeman PA, Ronald L. Moy MD| |
Treatment of Moderate to Severe Inflammatory Acne Vulgaris: Photodynamic Therapy with 5-Aminolevulinic Acid and a Novel Advanced Fluorescence Technology Pulsed Light Source
Michael H. Gold MD, Julie Biron BS| |
Osvaldo Tomás Vázquez-Martínez MD, Jorge Ocampo-Candiani MD, Nora Méndez-Olvera MD, Fitzgeraldo A. Sánchez Negrón MD| |
Stratum Corneum Abnormalities and Disease-Affected Skin: Strategies for Successful Outcomes in Inflammatory Acne
Laura Jordan DO MS and Hilary E. Baldwin MD b| |
J Drugs Dermatol. 2016;15(10):1170-1173.
Amy Forman Taub MDa,b and Ann Cameron Schieber PA-Ca| |
J Drugs Dermatol. 2015;14(11):1329-1334.
Jacqueline E. Greb BA, Caren Garber BA, and Alice B. Gottlieb MD PhD| |
OBJECTIVE: We evaluate disease characteristics and treatment response variation in the moderate-to-severe psoriasis population based on PsA history.
METHODS: Simple-measure for assessing psoriasis activity (S-MAPA) was used to retrospectively analyze treatment responses.
RESULTS: 191 moderate-to-severe psoriatic patients, 58 with and 133 without rheumatologist-diagnosed PsA were analyzed. Regardless of PsA history, S-MAPA improvement was similar with biologic monotherapy (46.2 versus 44.1; P=0.74), traditional systemic monotherapy (62.29 versus 38.12; P=0.22), and combination treatments (64.62 versus 52.71; P=0.40) after 12 weeks. PsA patients on biologic monotherapy experienced a higher infection rate than patients without PsA (0.57% versus 0.19%; P=0.01). PsA patients experienced more adverse events (AEs) associated with traditional systemic monotherapy than biologic monotherapy (3.25 versus 1.04; P=.001).
LIMITATIONS: The relatively small PsA cohort was the primary limitation.
CONCLUSIONS: Patients with moderate-to-severe psoriasis responded similarly to all treatments independent of PsA history. PsA patients received more overall treatments and more biologic monotherapy prescriptions. PsA patients had a greater infection risk on biologic monotherapy compared to those without PsA, and greater adverse events risk on traditional systemic monotherapy compared to biologic monotherapy.
J Drugs Dermatol. 2016;15(8):917-922.
A Retrospective Study on Efficacy of Pulsed Dye Laser and Intense Pulsed Light for the Treatment of Facial Telangiectasia
Lin Gao MD PhD,* Ni Gao MD,* Wenting Song MD, Erle Dang MD PhD, Rong Yin MD PhD, Li Wang MD, and Gang Wang MD PhD| |
Both pulsed dye laser (PDL) and intense pulsed light (IPL) systems have been demonstrated to be effective for treatment of facial telangiectasia, however there have been very few comparative studies between both treatments involving purely Asian patient populations. In this study, we performed a retrospective analysis to compare the efficacy of PDL and IPL systems for the treatment of facial telangiectasia. A total of 416 patients with facial telangiectasia who were treated by PDL or IPLs in our department from August 2012 to March 2015 were included in this study. The subjects received one of the following five treatments: PDL 595 nm (9-12 J/cm2), MaxG (500-670 nm & 870-1200 nm, 30-46 J/cm2), IPL (560-1200 nm, 18-24 J/cm2), M22 560 (560-1200 nm, 15-18 J/cm2), and M22 590 (590-1200 nm, 15-20 J/cm2). Each treatment had two sessions with 6-week intervals. The improvement percentage score in facial telangiectasia after the final treatment was evaluated by two non-treating physicians. We found almost all patients (less than 95.00%) had marked improvements or nearly complete clearance of the lesions after PDL 595 nm or MaxG treatment, as compared to 41.38%-56.58% patients in the other three groups that showed similar degrees of improvements. Both PDL 595 nm (9-12 J/cm2) and MaxG (500-670 nm & 870-1200 nm, 30-46 J/cm2) treatments resulted in significantly superior vessel clearance than the IPL systems with other wavelength bands (560-1200 nm or 590-1200 nm) and relatively lower fluence (15-24 J/cm2). Our results also suggested fluence levels account for the significant differences in the effectiveness delivered by different IPL systems. We concluded that PDL 595 nm and MaxG showed comparable clinical efficacy and both treatments resulted in most beneficial outcomes.
J Drugs Dermatol. 2017;16(11):1112-1116.
Scott A. Davis MAa and Steven R. Feldman MD PhDa-c| |
PURPOSE: To determine the frequency of prescribing calcipotriene and other psoriasis drugs in combination.
METHODS: Visits with a sole diagnosis of psoriasis were selected from 1990-2010 data from the National Ambulatory Medical Care Survey. The number of combination therapies used, the leading therapies in each class of medications, and the leading types used in combination were analyzed.
RESULTS: About 10.2 million of 20.3 million psoriasis visits used multiple treatments. The mean number of prescribed medications increased over time (P=.0003). The top 10 treatments included 6 topical steroids, calcipotriene, 2 other topicals, and methotrexate. The most common combinations were topical steroid plus other topical (15.0%), multiple topical steroids (11.5%), topical steroid plus vitamin D analogue (9.7%), and topical steroid plus systemic treatment (6.9%). Vitamin D analogues and systemic treatments were prescribed with increasing frequency over time, while fewer topical steroids were used, and use of other topicals did not change significantly.
LIMITATIONS: Visits with multiple diagnoses had to be excluded to ensure that the medications listed were for psoriasis.
CONCLUSIONS: Combination therapy is the most common way to treat psoriasis in the United States. The wide range of combination therapies prescribed may reflect increased attention to individualization of treatment to match patients’ diverse preferences.
J Drugs Dermatol. 2013;12(5):546-550.
Lucija Kroepfl MBChBa and Jason J. Emer MDb| |
John Patrick Welsh MD, Carrie Ann Cusack MD, Christine Ko MD| |
Observations: One to 3 treatments with this combination fractional laser device were performed on 16 Caucasian females with static periocular rhytides or skin laxity affecting the nasolabial crease. There was a 3-week period between treatments. Improvement was noted in both areas after a small number of treatments.
Conclusion: The technology behind fractional lasers is rapidly evolving, and new devices offer significant advances over older prototypes. where id= 776;
Case-based Considerations in the Treatment of Actinic Keratoses: Utilizing Combination or Sequential Therapy With 5-fluorouracil Cream and Destructive Treatments
Anne Han MD, Carolin Penrose MD, Arathi Goldsmith DO, Ellen S. Marmur MD| |
Ritu Saini MD| |
Anthony Chiaravalloti MDa and Michael Payette MD MBAb| |
OBJECTIVE: To review successful treatments of Hailey-Hailey, synthesize the evidence, and provide recommendations for therapy. Findings: The best evidence exists for treatment with topical steroids and topical antimicrobials. Refractory disease has shown the most benefit with addition of oral antibiotics, excisional procedures and botulinum toxin A. Other therapies are described but with much less supporting evidence.
CONCLUSIONS: Herein we review the literature to identify successful treatments for Hailey-Hailey disease. We have outlined the treatments with the most evidence. The difficult nature of treating this disease requires that clinicians approach each patient differently. The literature shows that no one regiment works for all patients.
J Drugs Dermatol. 2014;13(10):1254-1257.
S. Ray Peterson, MD and Leonard H. Goldberg, MD, FCRP| |
Jill Waibel MD, Kenneth Beer MD| |
J Drugs Dermatol. 2012;11(10):1158-1165.
Marie Rosalette Mortel BS and Jason Emer MD| |
Eliot F. Battle Jr. MD| |
J. Mark Jackson MDa and Michelle Pelle MDb| |
Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely. These vehicles come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique ingredients designed to optimize skin penetration and delivery of the active drug to its target. Vehicles can also influence tolerability, which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments than oral treatments. Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be nonirritating and be easy to use. Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active ingredient, skin barrier repair, tolerability and compliance.
J Drugs Dermatol. 2011;10(6):627-633.
A Double-Blind, Placebo-Controlled Pilot Study to Estimate the Efficacy and Tolerability of a Nonsteroidal Cream for the Treatment of Cradle Cap (Seborrheic Dermatitis)
Elmer David MD,a Hanan Tanuos MD,a Timothy Sullivan MD,b Albert Yan MD,c and Leon H. Kircik MDd-f| |
J Drugs Dermatol. 2013;12(4):448-452.
Terrence Keaney MD| |
J Drugs Dermatol. 2015;14(9):1036-1040.
Early Improvement in Rhytides and Skin Laxity Following Treatment With a Combination Fractional Laser Emitting 2 Wavelengths Sequentially
K. Wade Foster MD PhD, David J. Kouba MD PhD, Edgar F. Fincher MD PhD, Zachary S. Glicksman, Jennifer Hayes, Valerie Freeman PA, Helen H. Fincher MD, Ronald L. Moy MD| |
Observations: One to 3 treatments with this combination fractional laser device were performed on 16 Caucasian females with static periocular rhytides or skin laxity affecting the nasolabial crease. There was a 3-week period between treatments. Improvement was noted in both areas after a small number of treatments.
Conclusion: The technology behind fractional lasers is rapidly evolving, and new devices offer significant advances over older prototypes.
Kosta Y. Mumcuoglu PhD| |
Kenyatta Mireku BS,a Karen E. Huang MS,a Swetha Narahari MD,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
OBJECTIVE: To characterize psoriasis treatments by patients' types of payment in the US outpatient office setting.
METHODS: Using the National Ambulatory Medical Care Survey (NAMCS), a large survey that samples outpatient office visits to US non-federally funded physicians, visits linked with sole diagnoses for psoriasis (ICD-9-CM: 696.1) were identified. There were 545 unweighted records. The types and number of treatments prescribed at these visits were categorized by expected major payment type to be used for the visit.
RESULTS: Mainstay psoriasis therapies such as vitamin D analogs and clobetasol were prescribed regardless of payment type. Retinoids were also within the most frequently prescribed psoriasis medications for all payment types, however they were less frequently prescribed than vitamin D analogs. Payment type did not have a significant effect on the number of medications prescribed at psoriasis visits.
LIMITATIONS: Data on treatment adherence and filling of prescriptions are not included in the NAMCS database.
CONCLUSION: Prescribing patterns for psoriasis medications are similar across payment type. Additional factors appear to modulate therapy choice for patients with psoriasis.
J Drugs Dermatol. 2013;12(10):1095-1097.
E. Victor Ross MD, Michael Swann MD, Seaver Soon MD,Arash Izadpanah MD, David Barnette MD,Scott Davenport BA| |
Background: Traditional full-face resurfacing has been limited to erbium-doped yttrium aluminium garnet (Er:YAG) and carbon dioxide (CO2) lasers. These devices offer wavelength-specific advantages and disadvantages.
Methods: Nine patients were enrolled in a pilot study of a resurfacing system using a 2790-nm erbium:yttrium-scandium-galliumgarnet (Er:YSGG) laser system. Two treatments were carried out 1 month apart over the entire face. Test spots were performed prior to the full-face sessions to determine the optimal fluence for 1-pass laser resurfacing. Biopsies were performed at the time of treatment and at the final follow-up visit one month after the second treatment. Clinical endpoints included changes in pigment dyschromias, wrinkles, and skin tone. All outcomes were graded by blinded observers.
Results: Eight patients completed the 2 treatments. Biopsies showed thermal damage extending as deep as 80 μm below the stratum corneum. Reepithelialization was complete within 4 days. No scarring, post inflammatory hyperpigmentation (PIH), or infections were observed.
Conclusion: A 2790-nm laser can be used for skin rejuvenation with a 4 day recovery window.
Treatment of Poikiloderma of Civatte With AblativeFractional Laser Resurfacing:Prospective Study and Review of the Literature
Emily P. Tierney MD and C. William Hanke MD MPH| |
Background: Previous laser treatments for Poikiloderma of Civatte (PC) (i.e., Pulsed dye, Intense Pulsed Light, KTP and Argon) are limited by side effect profiles and/or efficacy. Given the high degree of safety and efficacy of ablative fractional photothermolysis (AFP) for photoaging, we set out to assess the efficacy of PC with AFP.
Design: A prospective pilot study for PC in 10 subjects with a series of 1−3 treatment sessions. Treatment sessions were administered at 6−8 week intervals with blinded physician photographic analysis of improvement at 2 months post-treatment. Evaluation was performed of five clinical indicators, erythema/telangiecatasia, dyschromia, skin texture, skin laxity and cosmetic outcome.
Results: The number of treatments required for improvement of PC ranged from 1 to 3, with an average of 1.4. For erythema/telangiecatasia, the mean score improved 65.0% (95% CI: 60.7%, 69.3%) dyschromia, 66.7% (95% CI: 61.8%, 71.6%), skin texture, 51.7% (95% CI: 48.3%, 55.1%) and skin laxity, 52.5% (95% CI: 49.6%, 55.4%). For cosmetic outcome, the mean score improved 66.7% (95% CI: 62.6%, 70.8%) at 2 months post treatment.
Conclusion: In this prospective study, AFP was both safe and effective for the treatment of the vascular, pigmentary and textural components of PC. The degree of improvement observed in wrinkling, creping and laxity after AFP has not been reported with prior laser treatments for PC.
Home-Based Wrinkle Reduction Using a Novel Handheld Multisource Phase-Controlled Radiofrequency Device
Neil S. Sadick MD,1 Yoram Harth MD,2,3 Andrew S. Dorizas MD,6 Hanna Levy PhD,4 and Avner Shemer MD5| |
PATIENTS AND METHODS: A total of 69 participants (age 54.3 years ± 8.09; age range 37-72 years) were enrolled in the study after meeting all inclusion/exclusion criteria (100%) and providing informed consent. Participants were provided with the tested device together with a user manual and treatment diary, to perform independent treatments at home for 4 weeks. The tested device, (Newa™, EndyMed Medical, Cesarea, Israel) emits 12 W of 1Mhz, RF energy through six electrodes arranged in a linear fashion. Independent control of RF polarity through each one of the 6 electrodes allows significant reduction of energy flow through the epidermis with increased dermal penetration. Participants were instructed to perform at least 5 treatments a week, for one month. Four follow-up visits were scheduled (once a week) during the period of independent treatments at home, following 4 weeks of home treatments, 1 month follow-up visit (1 month after treatment end) and at 3 months follow-up (3 months following treatment end).
Analysis of pre-and post treatment images was conducted by three uninvolved physicians experienced with the Fitzpatrick Wrinkle and Elastosis Scale. Fitzpatrick Wrinkle and Elastosis score of each time point (4 weeks following home use treatments; 1 month follow-up, 3 months follow-up) was compared to baseline.
Participants were asked a series of questions designed to explore usability concerns and level of satisfaction regarding the device use and subjective efficacy.
RESULTS: Altogether, 62 subjects completed the study course and follow-up visits. No unexpected adverse effects were detected or reported throughout the independent treatment. All study participants did not experience any difficulties while operating the tested device for independent wrinkle reduction treatments. Photographic analysis of pre- and post-one month of independent home use treatments, and one and three months follow-up after end of treatment course, was conducted by three uninvolved board certified dermatologists. Analysis of results revealed improvement (downgrade of at least 1 score according to the Fitzpatrick scale) in 91.93%, 96.77%, and 98.39% of study subjects (according to the first, second, and third reviewer, respectively). Results were found to be statistically significant. The majority of study participants were very satisfied from the results of the independent treatment using the tested device for wrinkle reduction.
J Drugs Dermatol. 2014;13(11):1342-1347.
John J. Kohorst,a Clinton Hagen,b Christian L. Baum MD,c Mark D. P. Davis MDc| |
OBJECTIVE: We sought to determine the treatments most commonly prescribed and the performance of all systemic and surgical treatments used in hidradenitis suppurativa patients in Olmsted County, Minnesota, treated over a 40-year period.
METHODS: A retrospective chart review was performed to evaluate hidradenitis suppurativa treatments in 376 episodes with 115 Olmsted County patients seen by a clinician at Mayo Clinic in Rochester, Minnesota, between 1968 and 2008. Treatment episode outcomes were recorded from clinical notes for the 73 treatment episodes that had a follow-up period of more than 30 days.
RESULTS: Systemic antibiotics alone were prescribed most frequently in 70.0% of episodes. Systemic antibiotics alone improved 39 of 49 treatment episodes (79.6%), including 13 episodes (26.5%) when the disease was fully cleared. All 5 of 5 episodes (100%) of surgical treatment alone improved, including 4 (80%) in which the disease was fully cleared. Surgery in combination with systemic antibiotic treatment yielded improvement in 5 episodes (71.4%), with 2 episodes (28.6%) showing complete clearance.
CONCLUSION: Systemic antibiotics were the most frequently prescribed treatment type in 115 patients over a 40-year period. Both systemic antibiotic therapy and surgical treatment are effective in disease management.
J Drugs Dermatol. 2014;13(7):827-831.
Stephanie J. Kang DO,a Scott A. Davis MA,a Steven R. Feldman MD PhD,a,b,c and Amy J. McMichael MDa| |
OBJECTIVE: To determine whether racial or ethnic groups are treated differently for dyschromia. The secondary objective is to discover the main treatments used and determine trends over time in demographics.
METHODS: We searched the 1993-2010 National Ambulatory Medical Care Survey (NAMCS) for visits associated with a diagnosis of dyschromia (ICD-9 codes 709.00 or 709.09). The demographics and leading treatments were tabulated, and trends over time were assessed by linear regression.
RESULTS: There were about 24.7 million visits for dyschromia over the 18-year period. Among 5,531,000 patients with the sole diagnosis of dyschromia, there were 2,800 visits from females and 1,200 visits from males per 100,000 population. Females were more likely to receive prescription combination therapy for dyschromia than males by a ratio of 10 to 1. Leading treatments overall prescribed by dermatologists included hydroquinone, topical corticosteroids, and retinoids. Asians were 27% more likely to receive a combination therapy than non-Asians. African Americans and Hispanics were less likely to have a procedure performed for dyschromia.
LIMITATIONS: Data are based on a number of ambulatory care visits, which does not allow direct estimation of prevalence.
CONCLUSIONS: Dyschromia is a significant concern for many patients, and this is especially true among patients of color. Treatment for dyschromia is influenced by skin type, and thus ethnic or racial groups are treated differently. Studies have shown that combination therapy may offer better results than a single medication for hyperpigmentation disorders. Combination agents may be underutilized in African Americans and Hispanics for dyschromia.
J Drugs Dermatol. 2014;13(4):401-406.
Treatment of Photoaging with a Very Superficial Er:YAG Laser in Combination with a Broadband Light Source
Alexander L. Berlin MD, Mussarrat Hussain MD, Robert Phelps MD, David J. Goldberg MD| |
Lana X. Tong MD MPH and Jeremy A. Brauer MD| |
J Drugs Dermatol. 2017;16(11):1095-1102.
Pedram Ghasri BS,a Brad A. Yentzer MD,a Tushar S. Dabade MD,a Steven R. Feldman MD, PhDa,b,c| |
Background: Combination therapy is a common and appropriate treatment strategy for moderate-to-severe psoriasis, as it provides for enhanced efficacy and decreased toxicity compared to the use of a single agent. Acitretin is an effective oral retinoid for psoriasis that seems to find its greatest value when complemented by other topical and systemic treatments.
Objective: The primary aim of this study is to assess the use of acitretin in combination with other treatments for psoriasis.
Methods: We assessed the use of acitretin for the treatment of psoriasis using nationally representative survey data from the National Ambulatory Medical Care Survey (NAMCS).
Results: Among visits where acitretin was listed in the NAMCS, other psoriasis medications were co-prescribed in 62 percent of visits. The co-prescribed medications included topical corticosteroids (51%), calcipotriene (31%), biologics (6%), cyclosporine (5%), methotrexate (5%) and tazarotene (2%).
Conclusion: The use of acitretin in combination with other psoriasis treatments, particularly topical corticosteroids and calcipotriene, is a common practice. Acitretin is co-prescribed with the biologics, likely because of the relative lack of overlapping effects on immune function. The immune-sparing method of action of acitretin makes combination treatment with the systemic agents an attractive treatment option, especially in patients where further immunosuppression is unwarranted.
J Drugs Dermatol. 2011;10(8):876-880.
Intense Pulsed Light Pulse Configuration Manipulation Can Resolve the Classic Conflict Between Safety and Efficacy
Inna Belenky PhD, Cruzy Tagger MD, and Andrea Bingham RE| |
J Drugs Dermatol. 2015;14(11):1255-1260.
Jeremy B. Green MD,a,b Andrei I. Metelitsa MD FRCPC,c,d Joely Kaufman MD,a,b and Terrence Keaney MDe,f,g,h| |
J Drugs Dermatol. 2015;14(9):1061-1064.
Susan Weinkle MDa,b and Michael Saco MDa| |
Aging gracefully has taken on a whole new meaning over the past few decades as new aesthetic treatments have been developed and are becoming more sophisticated by the day. The aging process, which is exacerbated by chronic UV exposure, results in dyspigmentation, loss of skin laxity, precancerous and cancerous skin lesions, fat loss and redistribution, and bone resorption. Laser and light devices can be used to treat dyspigmentation, while neuromodulators and soft tissue fillers can be used for rhytides and revolumization. Newer procedures include using resorbable polyglycolide/L-lactide suspension sutures with bidirectional cones for mid face revolumization, deoxycholic acid injections for submental fat reduction, and radiofrequency energy. Certain over-the-counter products can increase the risk of postprocedure bruising, while arnica and bromelain may help decrease this risk. Dermatologists continue to be at the forefront of aesthetic treatments, ready and willing to help the aging population look and feel their best.
J Drugs Dermatol. 2017;16(6 Suppl):s84-86.
Nazanin Saedi MDa and Anand K. Ganesan MDb| |
MATERIALS/METHODS: With approval from the institutional review board at the University of California, Irvine, an electronic survey was sent to practicing dermatologists that contained 18 questions regarding the approach to evaluating and treating hyperpigmentation under the eyes, in the axilla, and along the neck.
RESULTS: Fifty dermatologists completed the survey, and 46 (92%) reported treating patients with darker skin. The ethnic groups treated were Latino (97.8%), African American (97.8%), Middle Eastern (77.6%), and Asian (88.9%). Thirty-six reported treating patients with hyperpigmentation under the eyes, and 22 (61.1%) thought the hyperpigmentation was a result of idiopathic increase in melanin deposition. Forty-two responded to treating hyperpigmentation in the axilla, most of whom thought it was related to acanthosis nigricans (69.0%) or contact dermatitis (59.5%). Forty responded to treating hyperpigmentation on the neck, most of whom treated the condition with hydroquinone (66%). Treatments for these 3 areas were not found to be effective.
CONCLUSIONS: Hyperpigmentation under the eyes, under the arms, or on the neck is a significant problem in darker-skinned patients that is refractory to currently available treatments, highlighting the necessity of developing treatment approaches directed toward this population. Two cases of hyperpigmentation on the neck are presented, describing a new entity that primarily affects dark-skinned individuals.
J Drugs Dermatol. 2013;12(5):563-567.
Meredith K. Shaw,a Scott A. Davis MA,a Steven R. Feldman MD PhD,a,b,c and Alan B. Fleischer Jr. MDa| |
OBJECTIVE: To determine and analyze what courses of treatment and in what frequency are being utilized to combat psoriasis in the United States.
METHODS: Analysis of data from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) of the National Center for Health Statistics. Data were analyzed to examine the prevalence of different therapy techniques to combat psoriasis from 1993 through 2010. The trends for phototherapy, methotrexate (MTX), retinoids, cyclosporine A (CSA), systemic steroids, and biologics were all analyzed over the entire 18-year period and independently before and after the introduction of biologics in 2002.
RESULTS: From 1993 to 2010, the trend for total systemic treatments has not significantly increased (P=0.5). Frequency of phototherapy treatments significantly decreased from 1993 to 2010 (P<0.001). Since the introduction of biologics in 2002, their frequency has significantly increased, becoming the most frequently used treatment from 2008-2010 (P<0.0001).
LIMITATIONS: Severity of psoriasis was not recorded in the NAMCS and NHAMCS.
CONCLUSIONS: The frequency of systemic treatments to treat psoriasis has not significantly increased from 1993 to 2010. Despite the introduction of biologics, it appears that little progress has been made in reducing under-treatment of moderate-to-severe psoriasis.
J Drugs Dermatol. 2014;13(8):917-920.
Tejaswi Mudigonda BS, Tushar S. Dabade MD, Steven R. Feldman MD PhD| |
Background: 308 nm excimer laser phototherapy is efficacious in the treatment of localized psoriasis. Different approaches regarding
dose fluency, number of treatments, and maintenance have been utilized, and there is yet to be a consensus on standard protocol.
Objective: To characterize treatment parameters for 308 nm excimer laser phototherapy.
Methods: We performed a PubMed search for studies describing excimer laser treatment protocol with particular attention to dosage determination, dose adjustment, dose fluency, number of treatments, and maintenance.
Results: Seven prospective studies were found describing the excimer efficacy for psoriasis. All studies determined the initial treatment dose using either the minimal erythema dose (MED) or induration. Fluency ranged from 0.5 MED (low) to 16 MED (high); one study demon- strated that medium to high fluencies yielded better improvement in fewer number of treatments. Fluency adjustments during the course of treatment were important to minimize phototherapy-associated side effects. The use of higher fluencies was reported to result in higher occurrences of blistering. One study implemented a maintenance tapering of dose-frequency phase to better manage psoriasis flare-ups.
Conclusion: The 308 nm excimer laser is an effective therapy for psoriasis regardless of the method used to determine initial dosage, dose fluency, or number of treatments. As its usage as a targeted monotherapy increases, future trials should consider evaluating and modifying these parameters to determine the most optimal management of localized psoriasis. Based on our reviewed studies, there is no consensus for a single excimer laser therapy protocol and as a result, patient preferences should continue to be an important consid- eration for phototherapy regimen planning.
J Drugs Dermatol. 2012;11(1):92-97.
Jason J. Emer MD, Mary L. Stevenson MD, Orit Markowitz MD| |
Female-pattern androgenetic alopecia is a very common disorder that has been associated with extreme psychological morbidity. Few treatments have documented utility and many physicians are often overwhelmed with how little is pharmacologically available to treat this condition. Novel treatments that are effective, safe, less costly and simple are in high demand. We report a case of female-pattern androgenetic alopecia that failed to respond to a novel treatment with injected bimatoprost solution. Hypothetically, the treatment should have been effective and although we did not have success, this report suggests critical points to consider in the future of prostaglandin analogs, as well as other therapies being considered for the treatment of female-pattern hair loss.
J Drugs Dermatol. 2011;10(7):795-798.
Treatment of Actinic Cheilitis by Photodynamic Therapy With 5-Aminolevulinic Acid and Blue Light Activation
Martin Zaiac MD and Annabelle Clement MMS PA-C| |
J Drugs Dermatol. 2011;10(11):1240-1245.
Introduction: This study evaluated the efficacy and tolerability of treating mild-to-moderate facial acne using a new, hand-held,
light-emitting diode blue light device in conjunction with a foam cleanser containing 5% glycolic acid and 2% salicylic acid plus a skin
rebuilding serum containing 1.25% salicylic acid, 0.5% niacinamide, 0.08% liposomal-based azelaic acid and superoxide dismutase.
Methods: Volunteers with mild-to-moderate facial inflammatory acne used the blue light device twice daily for eight weeks, plus the cleanser before treatments and the serum after each evening treatment.
Results: Among 33 subjects aged 25–45 years old, 28 completed. In a 3 cm x 5 cm target area receiving a daily dose of ~29 J/cm2, treatment was associated with significant reductions from baseline in the inflammatory lesion count from week 1 onward (P≤.01) and in the non-inflammatory lesion count from week 4 onward (P≤.05). The number of flares was significantly reduced from baseline from week 2 onward (P≤.05), and flare severity and flare redness were significantly reduced from baseline from week 4 onward (P≤.01 and P≤.05, respectively). At week 8, more than 90 percent of subjects reported improvements in their skin’s overall appearance, clarity, radiance, tone, texture and smoothness. In addition, 82 percent were satisfied, very satisfied, or extremely satisfied with the blue light treatment system and 86 percent agreed the treatment system was much gentler than traditional acne treatments.
Conclusion: The blue light treatment system offers effective, rapid, convenient and well tolerated treatment of inflammatory and non-inflammatory acne lesions. The majority of subjects consider it much gentler than traditional acne treatments and it facilitates effective treatment without the need for antibiotic exposure. The blue light treatment system and blue light therapy alone are attractive treatment options for acne vulgaris, both as alternatives to traditional acne treatments and as adjunctive treatments to complement existing therapies.
J Drugs Dermatol. 2011;10(6):596-602.
Anne Chapas MD FAAD and Kendra Gail Bergstrom MD FAAD| |
Tacrolimus Ointment 0.1% Alone and in Combination with Medium-Dose UVA1 in the Treatment of Palmar or Plantar Psoriasis
Jennifer Rivard MD, Jennifer Janiga MD, Henry W. Lim MD| |
Andreas J. Bircher, MD and Christian Surber, MD| |
Five-Year Retrospective Review of Safety, Injected Volumes, and Longevity of the Hyaluronic Acid Belotero Basic for Facial Treatments in 317 Patients
Objective: The objective of this article is to report on use of this HA in a German clinic, over a period of 5+ years, in 317 patients (668 treatments).
Methods and Materials: Authors retrospectively examined patient charts of 317 patients (312 females), aged 24 to 87 years. Chart review showed areas treated, range of volumes per area, and mean volumes. Patient satisfaction data was collected anecdotally over the five years.
Results: Volumes of the HA injected ranged from 0.2 mL to 3.0 mL, depending on the area being treated. No serious adverse events were noted in the chart review, nor was any Tyndall effect observed in the treated areas. Anecdotal information suggests high patient satisfaction with results, based on the return of these patients to the clinic for other treatments over the more than five years.
Conclusion: Belotero Basic provides aesthetically pleasing results for treatment of facial defects, without carrying a risk of serious adverse events. North American physicians now have a new HA to consider as part of their treatment protocols.
J Drugs Dermatol. 2012;11(9):1032-1035.
By Danny Vleggaar MD, and Ute Bauer MD| |
Theodore Rosen MD,a Sheila Fallon Friedlander MD,b Leon Kircik MD,c Matthew J. Zirwas MD,d
Linda Stein Gold MD,e Neal Bhatia MD,f Aditya K. Gupta MD PhD MBAg
J Drugs Dermatol. 2015;14(3):223-228.
Treating Photodamage of the Décolletage Area With a Novel Copper Zinc MalonateComplex Plus Hydroquinone and Tretinoin
James J. Leyden MD and Lisa Parr PharmD| |
Treatment was associated with early and significant (P≤0.05) improvements in mean scores on an overall integrated assessment of photodamage (from week 4 onward) and for multiple signs of photodamage—tactile roughness (from week 2 onward); mottled hyperpigmentation, lentigines and fine wrinkling (from week 4 onward); laxity (from week 8 onward); and crepiness and coarse wrinkling (from week 12 onward). Treatment was generally well tolerated and 94% of subjects were satisfied or very satisfied with the overall improvement in their décolletage at week 24.
Comparison of Clindamycin 1% and Benzoyl Peroxide 5% Gel to a Novel Composition Containing Salicylic Acid, Capryloyl Salicylic Acid, HEPES, Glycolic Acid, Citric Acid, and Dioic Acid in the Treatment of Acne Vulgaris
Leslie S. Baumann MD, CPI,a Kristian Figueras MS,a Amanda Dahl BS CCRA,b Margarita Yatskayer MS,b and Christian Oresajo PhDb| |
J Drugs Dermatol. 2013;12(3):266-269.
Background:Over the past 10 years, radiofrequency (RF) technology has been utilized for nonablative treatments for the treatment of
rhytides and skin laxity. This manuscript reviews the scientific background of collagen synthesis in vivo and in response to RF energy as
well as a clinical study of 17 patients receiving a series of facial treatments with a 4-MHz monopolar RF (Pellevé,Ellman International,
Inc, Oceanside, NY). Clinical methods, results, and a review of the literature for RF aesthetic treatments of the face are presented.
Methods:Seventeen patients were treated in one site with 6 total treatments scheduled as follows:1 session was performed every 15 days for 2 consecutive sessions, 1 session every month for 2 consecutive sessions, and 1 session every 2 months for 2 consecutive sessions. Both the treating physician and the patients via live viewing and comparison with baseline photographs performed assessment of results. Results are reported as averages across the 17 patients.
Results: Two weeks after the first treatment,patients noted an overall average of 25% to 30% improvement. Just before the last or sixth treatment, there was an average of 50% improvement noted by the physician, with patients ranking an average self-improvement of 48%. The treating physician rated average improvement of 46% compared with baseline,whereas the patients ranked average improvement of 30% compared with baseline at 1 year after treatment was initiated (6 months after the final treatment).Patients find this treatment to be very well tolerated, with minimal to no discomfort and no downtime or significant side effects.
Conclusions: The Pellevé 4-MHz monopolar RF device is effective, safe, and very well tolerated for treating laxity, texture, and wrinkles of the skin without complication or discomfort. Evidence in the literature supports the scientific mechanism of action of acute collagen modification and continued neocollagenesis observed with the system. In this cohort, patients maintain approximately 50% improvement on average at 6 months and a 30% to 50% improvement 1 year after beginning the treatments, 6 months after completion.
Terrence C. Keaney MD FAAD,a,* Robert Anolik MD,b André Braz MD,c Michael Eidelman MD,d Joseph A. Eviatar MD FACS,e Jeremy B. Green MD FAAD,f Derek H. Jones MD,g Vic A. Narurkar MD,h Anthony M. Rossi MD FAAD,i and Conor J. Gallagher PhDj| |
BACKGROUND: The number of nonsurgical aesthetic procedures performed in men is growing rapidly. However, there are limited data on treatment principles and goals for the male aesthetic patient.
OBJECTIVE: To review the objective data available on male aging and aesthetics and to synthesize with expert opinion on treatment considerations specific to male patients.
METHODS: Expert advisors met to discuss anatomical differences in male versus female facial anatomy related to aging, facial treatment preferences in aesthetically oriented men, and current dosing data for facial injectable treatments in male versus female patients.
RESULTS: Symmetry, averageness, sexual dimorphism, and youthfulness are generally accepted as factors that contribute to the perception of attractiveness. There are differences between men and women in facial anatomy, concepts of attractiveness in the context of masculinity and femininity, and treatment objectives. A communication gap exists for men, as evidenced by the lack of information available online or by word of mouth about injectable treatments.
CONCLUSIONS: Approaches to aesthetic consultation and treatment should differ between men and women based on the fundamental dissimilarities between the sexes. Educating men about available aesthetic treatments and about the safety and side effects associated with each treatment, as well as addressing concerns about their treatment results looking natural, are key considerations.
J Drugs Dermatol. 2018;17(1):19-28.
Macrene R Alexiades-Armenakas MD PhD, Roy G Geronemus MD| |
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa| |
Patricia K. Farris MD,a Nicole Rogers MD,a Amy McMichael MD,b Sophia Kogan MDc| |
Hair loss is a complicated problem that causes significant concern for those who are affected. Patients seeking medical treatment have limited options that include topical minoxidil and oral finasteride. While these treatments are backed by long term clinical use and research outcomes, many patients find topical minoxidil difficult to incorporate into their daily routine and some are concerned with the side effects associated with finasteride. In the office setting, patients may be treated with more invasive procedures such as platelet-rich plasma injections (PRP) and hair transplantation, treatments that often must be repeated and can lead to a costly investment. Consumers are increasingly interested in natural treatments for hair loss. Many turn to basic supplements only to be disappointed when they fail to deliver due to lack of standardization and efficacy. In this paper we review the benefits of a nutraceutical containing a specific blend of highly purified, standardized, bio-optimized, and bioavailable botanical extracts to treat hair loss. These phytoactives were selected because of their diverse multi-modal biologic activity against inflammation, DHT, stress mediators, oxidative damage, and intermediary signaling cascades. This supplement represents a paradigm shift as it addresses not only the factors that trigger hair loss but the downstream mediators of inflammation as well. Multi-center clinical studies are currently underway to confirm the efficacy and benefits of this unique nutraceutical.
J Drugs Dermatol. 2017;16(11 Suppl):s141-148.
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Vineet Mishra MD,a Lee Miller MD,b Salman M. S. Alsaad MD,c and E. Victor Ross MDb| |
METHODS: Five female patients (age range, 30-60) with abdomen striae alba (n=4) and striae rubra (n=1) were enrolled in the study. Skin type distribution among the 5 patients was two type II, one type III, and two type IVs. The device (Accent XL, Alma Lasers Inc.) is a radiofrequency fractional platform (40.68 MhZ) that deploys multiple conical pin electrodes on a moving handheld 6 cogs roller. Four treatments were performed every two weeks with settings based on test spots performed two weeks prior to a full treatment session. Assessment of striae was based on clinical severity of the lesions on a 1-4 scale, with “4” being the most severe. A questionnaire was administered to patients with possible subjective responses ranging from 0-4, with 0 being no improvement and quartiles from 1-4 (1= mild improvement, 2= fair improvement, 3= moderate improvement, and 4= marked improvement, respectively).
RESULTS: Three months after 4 treatments, a mean improvement of 20% was achieved (mean severity score changed from 2.9 to 2.5). Micro-wounds were approximately 200 μm wide on the surface, initially presenting as small gray “dots” and evolving into black dots lasting about 2 weeks. Mean pain was 2/10. Erythema and edema persisted for about one day. No pigmentation abnormalities were observed at the final evaluation. The results from the patient questionnaire revealed a mean score of 2.4/4, thus falling in the range of good to very good.
CONCLUSION: A fractional ablative micro-plasma RF roller device can improve improvement in the appearance of abdomen striae.
J Drugs Dermatol. 2015;14(11):1205-1208.
The Effects of a Daily Skincare Regimen on Maintaining the Benefits Obtained from Previous Chemical Resurfacing Treatments
Suzanne Bruce MD,a Wendy Roberts MD,b Craig Teller MD,c and Lora Colvan BSd| |
OBJECTIVES: To evaluate whether a daily skin care regimen used for 12 weeks could maintain the benefits achieved with AGE and MELA chemical resurfacing treatments.
METHODS: Subjects who completed participation in the AGE and MELA skin resurfacing clinical trial were recruited to participate in a continuation trial and used a daily regimen of MDRejuvena facial products for 12 weeks. No other facial products were permitted. Physicians assessed the severity of individual skin parameters at baseline and week 12 and provided global assessment. Subjects assessed improvement of individual skin parameters at week 12 and provided an overall assessment.
RESULTS: Thirteen subjects participated in the 12-week continuation trial. According to the physician’s global assessment, all subjects demonstrated some level of improvement at week 12 compared to baseline. Physician assessment showed a decrease in severity of all skin parameters assessed at week 12 compared to baseline. According to the subject overall assessment at week 12, 11 of 12 subjects noted some level of improvement, 1 subject saw no improvement, and 1 subject did not provide an overall assessment. Mild to moderate improvement was observed by subjects in all individual skin parameters assessed except for skin discoloration.
CONCLUSIONS: The results of the continuation study demonstrate that use of a daily skin care regimen, which include combination of 2 various strengths of MDRejuvena Rejuvaphyl® Rejuvenating Complex: low strength (LS) and high strength (HS), not only maintains but can enhance the beneficial effects of skin resurfacing treatments for at least 12 weeks.
J Drugs Dermatol. 2016;15(9):1145-1150.
Patrick Bitter Jr. MD| |
A Prospective, Neurophysiologic Comparative Study to Assess the Efficacy and Duration of Effect of IncobotulinumtoxinA and AbobotulinumtoxinA in the Treatment of Crow’s Feet
Anastasia Saybel MD,a Ada Artemenko MD PhD,b Sergei Nikitin MD PhD,c and Alexei Kurenkov MD PhDd| |
J Drugs Dermatol. 2015;14(11):1291-1296.
Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR)
Kim Papp MD PhD,a Alice B. Gottlieb MD PhD,b Luigi Naldi MD,c David Pariser MD,d Vincent Ho MD,
e Kavitha Goyal MD,f Steven Fakharzadeh MD PhD,f Marc Chevrier MD PhD,g Stephen Calabro MS,f
Wayne Langholff PhD,g and Gerald Krueger MDh
OBJECTIVE: To assess the risk of adverse events of special interest (AEoSIs) with ustekinumab and other psoriasis treatments in a real-world setting using 2014 Psoriasis Longitudinal Assessment and Registry (PSOLAR) data. AEoSIs included malignancy (excluding nonmelanoma skin cancer), major adverse cardiovascular events (MACE), serious infection, and all-cause mortality.
METHODS: Cumulative rates of AEoSIs/100 patient-years (PY) are reported for ustekinumab, infliximab, other biologics (mostly adalimumab/etanercept), and non-biologics based on pre-specified analyses using attribution rules biased against ustekinumab. Risk factors for AEoSIs, including treatments, were determined using multivariate statistical analysis.
RESULTS: A total of 12,093 patients (40,388 PY) were enrolled in PSOLAR. Overall incidence rates were 0.68/100PY for malignancy, 0.33/100PY for MACE, 1.60/100PY for serious infection, and 0.46/100PY for mortality. Unadjusted rates of serious infection for infliximab (2.91/100PY) and other biologics (1.91/100PY) were numerically higher compared with ustekinumab (0.93/100PY). Exposure to the combined group of biologics other than ustekinumab was significantly associated with serious infection (hazard ratio=1.96, P<.001). None of the biologics was associated with increased risk of malignancy, MACE, or mortality.
LIMITATIONS: Observational data have inherent biases.
CONCLUSION: Analysis of 2014 PSOLAR data identified no increased risk of malignancy, MACE, serious infection, or mortality with ustekinumab.
J Drugs Dermatol. 2015;14(7):706-714.
Joel L. Cohen MD| |
METHODS: Two patients underwent surgery to remove facial skin cancer tumors. The resulting scars after reconstruction of these skin cancer defects on the left cheek (Case 1) and right cheek (Case 2) each received 3 treatments with a fractional ablative laser device (ProFractional-XC, Sciton, Inc., Palo Alto, CA). Treatments were spaced about 1 month apart. Topical anesthetic cream applied 1 hour before treatment minimized patient discomfort during the procedure. Treatment depths ranged from 150 to 200 microns, 2 passes were performed, and coverage per pass was typically 22% and then 11% in the coagulation mode. Results were evaluated by digital photography before the initial treatment, approximately 4-5 weeks after each of the 3 treatments, and at approximately 7 months after the surgical procedures.
RESULTS: The fractional Er:YAG laser device significantly improved postsurgical scar lines in each patient without significant adverse effects. Prior to the laser sessions, these scars demonstrated hypopigmentation, hyperpigmentation, neovascularization, or diminished pore structures compared to the surrounding skin. These pigmentary, vascular or textural issues were all significantly improved by the fractional ablative Er:YAG laser.
CONCLUSION: The ablative fractional laser device of the present report safely minimizes and improves facial scars demonstrating not only textural alterations but also some pigmentary and vascular changes after reconstruction of skin cancer defects.
J Drugs Dermatol. 2013;12(10):1171-1173.
Long-Pulsed Dye Laser-Mediated Photodynamic Therapy Combined with Topical Therapy for Mild to Severe Comedonal, Inflammatory, or Cystic Acne
Alexiades-Armenakas MD PhD| |
Pilar Luis-Montoya MD, Patricia Pichardo-Velázquez MD, María Teresa Hojyo-Tomoka MD, Judith Domínguez-Cherit MD| |
Mira Stotland MD, Anne M. Chapas MD, Lori Brightman MD, Sean Sukal MD, Elizabeth Hale MD, Julie Karen MD, Leonard Bernstein MD, Roy G. Geronemus MD| |
Objective: To determine the safety and efficacy of fractional photothermolysis treatment on striae alba and striae rubra.
Methods: Twenty female patients with striae rubra or striae alba on their abdomen, thighs, or buttocks were enrolled in the study. Lesions were randomized to receive treatment, with site-matched normal control areas. Patients received a total of 6 treatments using a 1550-nm, erbium-doped fiber laser with 2 to 3 weeks of elapsed time between treatments. Clinical response to treatment was assessed at each visit, and at 1-month, 2-month, and 3-month follow-up intervals by the patient and investigator. A comparison evaluation of 8 patients examining photographs of striae at baseline and at the 3-month follow-up evaluation which was assessed by 4 independent dermatologists using the quartile grading scale.
Results: The independent evaluators’ assessments of improvement from photographs of 8 randomly selected patients showed an overall improvement of 26% to 50% in 63% (5/8) of patients. A less than 25% improvement in dyschromia was noted in 50% (4/8) of patients. An improvement in texture of 26% to 50% was observed in 50% (4/8) of patients. The clinical responses were indepen- dent of age, gender, and skin phototype. The treatments were tolerated well by all patients with a majority of patients experiencing transient posttreatment erythema and edema.
Conclusion: Fractional photothermolysis can be effectively and safely used in the treatment of striae rubra and striae alba.
The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments
Carl S. Hornfeldt PhD RPha and Mark Hollandb
Panel Discussion with Vivian W. Bucay MD,c Wendy E. Roberts MD,d Heidi A. Waldorf MD,e
and Steven H. Dayan MDf
J Drugs Dermatol. 2015;14(suppl 9):s15-s22.
Facial Contouring With Fillers, Neuromodulators, and Lipolysis to Achieve a Natural Look in Patients With Facial Fullness
Chytra Anand MD| |
Erin Courtney RN BSN and David J. Goldberg MD JD| |
Stacy Smith, MD; Dan Piacquadio, MD; Vera Morhenn, MD; Deborah Atkin, MD and Richard Fitzpatrick, ND| |
The purpose of this study was to compare the efficacy and tolerability of PDT using short incubation time, broad area treatment with ALA plus activation with either blue light or laser light to topical 5-FU in the treatment of AK of the face and scalp.
Thirty-six subjects with AK of either the face or scalp were randomized to receive either application of ALA for 1 hour followed by activation with blue light or pulsed dye laser or topical 5-FU. Efficacy was evaluated by grading AK lesions and photoaging signs. Tolerability was assessed by scoring crusting /erosions, erythema and stinging /burning.
Treatment with PDT using ALA plus blue light was as effective as topical 5-FU in clearing AK. PDT using ALA plus laser light was the least effective treatment. All treatments made improvements in the signs of photoaging. Both PDT treatments were better tolerated than 5-FU.
In conclusion, broad area PDT treatment with ALA plus activation with blue light appears to be as effective as 5–FU in the treatment of AK. ALA plus laser light is somewhat less effective than the above therapies. Efficacy could likely be improved with further study of laser parameters and incubation tim
Linda Stein Gold MD,a Jerry Tan MD,b and Leon Kircik MDc| |
OBJECTIVES: We evaluated differences in outcome measures and definition of success in acne trials; and their impact on FDA approval and indications for acne medications.
METHODS: Review of acne clinical trial literature, prescribing information and regulatory guidelines for currently approved acne medications in the United States.
RESULTS: Numerous IGA scales exist with variations in specific categorical definitions. There are also differences in definitions of global success. Outcome success may not be accurately translated into corresponding terminology for indications.
CONCLUSIONS: Variability in IGA scales and definitions of success confound comparison of trial results for acne treatments. Harmonization and standardization of these factors will facilitate meta-analytics and treatment selection in patient care. Outcome measure success has not consistently been incorporated into acne medication indications.
J Drugs Dermatol. 2016;15(1):79-86.
Prospective Clinical Evaluation of 1440-nm Laser Delivered by Microarray for Treatment of Photoaging and Scars
Robert A. Weiss MD, Michael Gold MD, Natalie Bene MD, Julie A. Biron, Girish Munavalli MD, Margaret Weiss MD, Karen Beasley MD| |
Consuelo V. David BA,a Hong Nguyen BS,b Gary Goldenberg MDc| |
The immunomodulatory characteristics and topical application of imiquimod (IQ), a toll-like receptor 7 agonist, have lead to extensive off-label therapeutic trials. Off-label use is not uncommon in dermatology. However, clinicians must make informed decisions to ensure safe and effective implementation when standardized protocols are lacking. We present the highest level of clinical evidence for each off-label application of IQ, summarize management steps, treatment regimens, and results. We hope consolidation of this information will facilitate implementation of informed and evidence-based clinical decisions. Forty-six off-label applications were reported. Treatments were generally applied in the same manner, tailored to induce an inflammatory response and reduced with the development of adverse reactions. The efficacy of imiquimod ranged from promising to suboptimal compared to standard treatments and protocols. Clinicians who choose to use IQ off-label should have a firm understanding of the extent an application has been studied and how to manage adverse events.
J Drugs Dermatol. 2011;10(11):1300-1306.
J Drugs Dermatol. 2011;10(2):125-132
Kyle B. Bartlett MD,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
OBJECTIVE: To examine how tolerability is assessed, tolerability ratings, and clinical significance of tolerability ratings of topical antimicrobials for acne.
METHODS: A literature search was performed using the terms “tolerability AND acne AND (benzoyl peroxide OR antimicrobial OR clindamycin OR erythromycin OR dapsone OR sulfur OR sulfacetamide).” Inclusion criteria were: 1) evaluation of tolerability, 2) use of an identified topical antimicrobial for acne treatment without combination retinoid use, 3) an original study, in English.
RESULTS: Thirty-four of 132 articles met the inclusion criteria. Tolerability was measured through subject and investigator assessment of specific tolerability parameters and by reporting of adverse events. Nearly all of the acne treatments were well tolerated. Treatment related study discontinuation rates were low and had little to no relation to the degree of tolerability measures.
LIMITATIONS: Patients may be more adherent in clinical trials than in clinical practice. Differences in the measure used to assess tolerability make comparisons difficult.
CONCLUSIONS: Topical antimicrobial acne therapy is generally well tolerated. Discontinuation rates are low under study conditions. Tolerability of topical antimicrobial therapy for acne may not have great clinical significance.
J Drugs Dermatol. 2014;13(6):658-662.
Comparison of the Cutaneous Thermal Signatures Over Twenty-Four Hours With a Picosecond Alexandrite Laser Using a Flat or Fractional Optic
Emil A.Tanghetti MDa and Danielle M.Tartar MD PhDb| |
Comparison of the Efficacy of Biologics Versus Conventional Systemic Therapies in the Treatment of Psoriasis at a Comprehensive Psoriasis Care Center
Shiu-chung Au MD,a Abdulaziz Madani MD,a Marwan Alhaddad MD,a Maha Alkofide MD,a and Alice B. Gottlieb MD PhDa,b| |
DESIGN: Retrospective, cross-sectional
METHODS: All patient visits with a code for psoriasis (ICD-9 696.1) in the clinical practice of two dermatologists with a high percentage (over 70% of chief complaints) of psoriasis patients from Jan 1, 2008 to Jan 4, 2012 inclusive were included in this retrospective data analysis. Patients were excluded if the baseline Physician's Global Assessment (PGA) at start of treatment was unknown, or less than 3 (moderate). The practice is a comprehensive psoriasis care center in the Northeastern United States serving a metropolitan population of over 4 million people. Patients were divided by treatment type (biologic, conventional systemic or both) and history of previous treatments. Patients were evaluated by Body Surface Area (BSA), PGA, Simple-Measure for Assessing Psoriasis Activity (S-MAPA, calculated by BSA multiplied by PGA). Patients were evaluated at baseline, 8, 12, 16, and 24 weeks after start of treatment. Patients must have completed at least 8 weeks on a single treatment in order to be included.
RESULTS: 46 courses of biologics, 12 courses of conventional systemic therapies, and 18 courses of both together were identified with PGA 3 or greater at baseline. Baseline S-MAPA for biologics was 74, for non-biologic systemics was 62.25. At week 24, S-MAPA improved 70.2% over baseline in patients treated with biologics, patients treated with non-biologic systemics improved by only 40.4% (P<0.05). The average number of prior treatments for patients on biologics was 1.87 versus 1.25 for patients on conventional systemic therapies (P=0.169).
CONCLUSION: Biologics show superior results to conventional systemic therapies (70% improvement versus 40% improvement) for the treatment of patients with moderate to severe psoriasis, as measured by decrease in S-MAPA (PGA multiplied by BSA) at week 24. These results were observed despite the fact that patients on biologics had a greater baseline severity and had a greater number of previous treatments.
J Drugs Dermatol. 2013;12(8):861-866.
Alice He BS,a Steven R. Feldman MD PhD,a,b,c and Alan B. Fleischer Jr. MDd| |
Comparative Results in Treatment of Keloids With Intralesional 5-FU/Kenalog, 5-FU/Verapamil, Enalapril Alone,Verapamil Alone, and Laser: A Case Report and Review of the Literature
Doru Alexandrescu MD,a Sabrina Fabi MD,b Lindsey C.Yeh MD MS, c Richard E. Fitzpatrick MD,b and Mitchel P. Goldman MDb| |
Photodynamic Therapy with Topical Aminolevulinic Acid and Pulsed Dye Laser Irradiation for Sebaceous Hyperplasia
Tina S. Alster, MD and Elizabeth L. Tanzi, MD| |
Lyn C. Guenther MD FRCPC,a Anneke Andriessen PhD,b Charles W. Lynde MD FRCPC,c John W. P.Toole BSc MD FRCPC,d Gary R. Sibbald MD FRCPC MACP FAAD M.Ed DSc (Hons),e James N. Bergman MD FRCPC,f Marc Bourcier MD FRCPC,g and Ian D.R. Landells MD FRCPCh| |
Neil S Sadick MD, Robert Weiss MD, Suzanne Kilmer MD, Patrick Bitter MD| |
Jeremy A. Brauer MD,a,d David H. McDaniel MD,b Bradley S. Bloom MD,d Kavitha K. Reddy MD,a
Leonard J. Bernstein MD,a,c and Roy G. Geronemus MDa,d
OBJECTIVE: We investigated the safety and efficacy of a fractionated 1927nm non-ablative thulium laser for the treatment of photo-induced pigmentation.
METHODS: Prospective multi-center study of subjects with clinically identifiable photopigmentation. The study protocol was approved by BioMed Institutional Review Board (San Diego, CA). Subjects received two treatments with a non-ablative 1927nm fractionated thulium laser (Fraxel Dual 1550/1927 Laser System, Solta, Hayward CA), energy level of 10mJ, coverage of 40% and 4-6 passes. Subject pain, erythema and edema were recorded immediately after treatment. Two dimensional photography was obtained before each treatment and at one and three month follow up visits. Independent blinded physician assessment was performed evaluating overall improvement in appearance as well as pigment specific improvement.
RESULTS: Forty men and women, ages 30 to 80 years, Fitzpatrick skin types I-IV, with photo-induced facial pigmentation were enrolled and treated, and 39 completed the three month follow up visit. Mean pain sensation for subjects during laser treatments was reported to be 4.3 on a 10-point scale. Mean scores for erythema, edema, and skin roughness throughout all treatments indicated moderate erythema, mild edema and mild skin roughness. Assessment of overall improvement was graded as moderate to very significant in 82% of subjects at one month and in 69% of subjects at three months after the second treatment. Assessment of lentigines and ephelides demonstrated moderate to very significant improvement in approximately 68% of subjects at the one month and in 51% of subjects at three months after the second treatment. Independent blinded physician assessment of randomized photography also demonstrated a durable response at three month follow up visit. Treatment was well tolerated and no serious adverse events related to treatment were observed or reported. Study limitations included a limited number of male subjects, lack of Fitzpatrick skin types V and VI, and decrease in improvement at 3 months post-treatment.
CONCLUSIONS: Two treatments with a 1927nm non-ablative fractionated thulium laser produced moderate to marked improvement in overall appearance and pigmentation with high patient satisfaction. The response to treatment was maintained at one and three months follow up.
J Drugs Dermatol. 2014;13(11):1317-1322.
Treatment of Photoaging With a Dual-Wavelength, 532 nm and 1,064 nm Picosecond-Domain Laser Producing a Fractionated Treatment Beam Using a Holographic Optic
Eric F. Bernstein MD MSE,a Kevin T. Schomacker PhD,b Amit S. Paranjape PhD,b Jayant D. Bhawalkar PhDb| |
BACKGROUND: A dual-wavelength, picosecond-domain, fractionated laser delivering 1,064nm and 532nm laser energy through a holographic optic was investigated for safety and effectiveness at improving the appearance of chronic photoaging. MATERIALS AND METHODS: A total of 27 subjects were enrolled with 24 completing the study, and 14 subjects were treated with 1,064 nm and 10 with 532 nm. The 1,064 nm-treated subjects received 5 monthly treatments while the 532 nm-treated subjects received 4 monthly treatments. Improvement was measured by blinded evaluation of pre- and post-treatment images 12 weeks following the final treatment. Subjects also evaluated treatment effect and side-effects. RESULTS: Blinded reviewers correctly identified the baseline image in 52 of 72 paired images, or 72% of the time, with a mean improvement score of 1.4 using an 11-point rating scale (P less than 0.0001). Post-treatment erythema, mild edema, and petechiae were the only side effects noted. CONCLUSION: The fractionated, picosecond-domain, 532 nm and 1,064 nm laser is safe and effective for improvement of facial photodamage. The laser was well tolerated with mild erythema, edema, and petechiae as the most common side-effects.
J Drugs Dermatol. 2017;16(11):1077-1082.
Pravit Asawanonda MD DSc, Thanapong Sutthipong MD, Nattapa Prejawai MD| |
Full-Face Injections of Variable Total Doses of Abobotulinum Toxin Type A: A Randomized, Phase IV Clinical Trial of Safety and Efficacy
Doris Hexsel MD,a,b Cristiano Brum MD Ms,a,c Manoela D. Porto MD,a Mariana Soirefmann MD Ms,a,b Carolina Siega BSc,a Juliana Schilling-Souza BPharm,a and Ticiana C. Rodrigues MD PhDa,d| |
OBJECTIVE: To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A (ABO).
METHODS: A total of 90 participants were enrolled. Subjects had at least two indications for BoNT-A treatments on each third of the face (upper, middle and lower). They were randomized into 3 groups, with pre-defined total dose range of ABO, varying from 120 to 250 U.
RESULTS: Most of the subjects were women (96.5%). The statistically significant improvement from baseline lasted for more than 24 weeks for glabellar lines, and more than 16 weeks for forehead wrinkles and crow's feet, all P<0.001, with no differences between groups. The most frequent adverse event (excessive perioral weakness) was related to high dose in the perioral area.
CONCLUSIONS: This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously. As long as the recommended doses are used, concomitant injections of ABO are safe and efficient, with no increase in adverse events.
J Drugs Dermatol. 2013;12(12):1356-1362.
Noel M. Prevost MPAS PA-C, Joseph C. English III MD| |
Effect of Controlled Volumetric Tissue Heating with Radiofrequency on Cellulite and the Subcutaneous Tissue of the Buttocks and Thighs
Ramón H. Rosado MD, Ma. Emilia del Pino MD, Alejandro Azuela MD, Ma. Graciela Guzmán MD,| |
Braden McKnight BS,a Rachel Tobin BS,b Yasmeen Kabir MD,c and Ronald Moy MDa| |
METHODS & MATERIALS: Twelve females received eight weekly non-ablative treatments using a tripolar radiofrequency device on the anterior and posterior upper arms. Evaluations included body weight, photographs, and circumference measurements at baseline and each subsequent week throughout the 8-week time period. The subjects and the investigator completed evaluations of clinical improvement using a 5-point assessment scale.
RESULTS: A significant circumference reduction was achieved in each arm of all twelve patients. A mean reduction of 1.99 ± 0.94 cm (P=0.001) was observed between the initial and final measurements after the 8-week treatment period. At the 4-week follow up, the average circumferential reductions of the posterior and anterior upper arms were sustained. Patient evaluations indicated moderate to good improvement of size, tightness, and overall appearance. The procedure was well tolerated without pain.
CONCLUSION: Tripolar radiofrequency devices offer a safe and effective non-invasive technology with beneficial effects on the circumferential reduction and overall appearance of the posterior and anterior upper arms.
J Drugs Dermatol. 2015;14(12):1463-1466.
Dapsone Gel 5% in Combination With Adapalene Gel 0.1%, Benzoyl Peroxide Gel4% or Moisturizer for the Treatment of Acne Vulgaris: A 12-Week, Randomized,Double-Blind Study
Alan B. Fleischer Jr. MD, Alan Shalita MD, Lawrence F. Eichenfield MD, William Abramovits MD,Anne Lucky MD, Steven Garrett DDS, for the Dapsone Gel in Combination Treatment Study Group| |
Methods: This was a twelve-week, randomized, double-blind study. Patients aged 12 years and older (n=301) applied dapsone gel twice daily and were randomly assigned (1:1:1) to one of three additional treatments, applied once daily.
Results: By week 12, dapsone gel combined with any of the three additional treatments reduced the mean number of inflammatory lesions. However, the authors did not detect a significant difference in the reduction of inflammatory lesions when dapsone was used in combination with adapalene gel or with benzoyl peroxide gel compared to the dapsone plus moisturizer combination group (P=0.052 for both versus moisturizer combination). Patients treated with dapsone gel combined with adapalene showed a significantly better response in reduction in non-inflammatory and total acne lesion count than those who received the moisturizer combination. Local adverse reactions in all three treatment groups were minimal and generally mild in severity.
Conclusion: Dapsone gel in combination with adapalene gel or benzoyl peroxide gel is safe and well tolerated for the treatment of acne vulgaris.
April A. Larson MD, Mitchel P. Goldman MD| |
A Clinical Evaluation of a Next Generation, Non-Invasive, Selective Radiofrequency, Hands-Free, Body-Shaping Device
Nicole Hayre MD,a Melanie Palm MD,b and Peter Jenkin MDc| |
Sabine Zenker MD| |
INTRODUCTION: Looking at alternatives to standard injectables and devices for rejuvenation, typical indications for facial rejuvenation are poor skin quality, pigmentary changes, and the loss of shape. Looking for effective treatments for those indications in the aesthetic field, one can notice a kind of “retro”-trend: easy-to-perform, non- or minimally-invasive, low-investment-requiring procedures are regaining a lot of popularity. And, over time, those treatments are becoming well defined and far more specific.
OBJECTIVE: To discuss an indication-specific full-face concept for facial rejuvenation using alternatives to standard injectables and devices for rejuvenation. Materials and Methods: The strategy of this indication-specific full-face concept is based on a three-pillar-principle: regeneration, regulation, and reshaping. In parallel to this concept, major indications such as poor skin quality, pigmentary changes, and loss of shape and definition are discussed. To address those indications, therapeutic principles such as topicals (cosmeceuticals, magistral formulations), mesotherapy, needling, chemical peelings, injection lipolysis, and thread lifting will be demonstrated.
CONCLUSION: As an alternative to standard injectables and devices, an indication-specific approach for a concept of full-face rejuvenation is based on the three-pillar-principle of regeneration, regulation, and reshaping by easy-to-perform, non- or minimally-invasive procedures for rejuvenation.
J Drugs Dermatol. 2017;16(6 Suppl):s98-103.
Safety and Efficacy of a New Device Combining Radiofrequency and Low-Frequency Pulsed Electromagnetic Fields for the Treatment of Facial Rhytides
Methods: Thirty-one subjects with facial wrinkles and rhytides were entered into this study. Every subject received 10 treatments of the face with a device that combines 1 MHz radiofrequency with PEMF with a flux of 15 gauss. Patients rated the pain level immediately after the treatment by using a visual analog scale (VAS) for pain. Side effects were recorded at every visit. The study's efficacy end point was evaluated by 2 blinded physicians who rated the standardized pictures from baseline and 3-month follow-up using the Fitzpatrick Wrinkle and Elastosis Scale (FWES).
Results: No unexpected adverse side effects were detected or reported for the duration of the study. Both raters recognized improvements of at least 1 grade on the FWES in 30 of 31 subjects (97%). The score decreased from 5.2 before the first treatment to 3.6 at 3 months after the last treatment. Furthermore, all patients rated the treatment to be free of pain on the VAS pain scale.
Conclusion: The results of this study show that the combination of multipolar RF with PEMF is a safe, effective, and painless approach to treat facial rhytides and is suitable to answer the demands of patients for safe treatments without pain or downtime.
J Drugs Dermatol. 2012;11(11):1306-1309.
Treating Onychomycoses of the Toenail: Clinical Efficacy of the Sub-Millisecond 1,064 nm Nd: YAG Laser Using a 5 mm Spot Diameter
Background: Onychomycosis is a relatively common fungal infection. Current treatments have limited applicability and low cure rates.
Recently introduced laser therapy has shown to be a safe and effective treatment for onychomycosis. In this study, we evaluate a submillisecond Nd:YAG 1,064 nm laser for treating onychomycoses of the tonail.
Methods: Thirteen subjects (9 female, 4 male) with 37 affected toenails received 1 to 3 treatments 4 and/or 8 weeks apart with a sub-millisecond 1,064 nm Nd:YAG laser. Diagnosis of onychomycosis was confirmed with microscopy. Average follow-up time was 16 weeks post-final treatment. Photos were taken and degree of turbidity was determined using a turbidity scale (ranging from "0 = clear nail" to "10 = completely turbid nail") at each visit. Improvement in turbidity was determined by comparison of turbidity scores at baseline and 16-week follow-up on average. Efficacy was assessed by an overall improvement scale (0 to 4), which combined improvement in turbidity scores and microscopic examination. Overall improvement was classified as "4 = complete clearance" if the turbidity score indicated "0 = clear nail" accompanied by a negative microscopic result. No microscopic examination was performed unless the turbidity score showed "0 = clear nail."
Results: Treatments were well tolerated by all subjects and there were no adverse events. Of the 37 toenails treated, 30 (81%) had "moderate" to "complete" clearance average of 16 weeks post-final treatment. Nineteen toenails (51%) were completely clear and all tested negative for fungal infection on direct microscopic analysis. Seven (19%) toenails had significant clearance and four (11%) had moderate clearance.
Conclusions: The preliminary results of this study show this treatment modality is safe and effective for the treatment of onychomycosis in the short term. Additional studies are needed to more fully assess the clinical and mycological benefits as well as optimize the treatment protocol and parameters.
J Drugs Dermatol. 2012;11(4):496-504.
Dornechia George MD, Ted Rosen MD| |
Scott A. Davis MA,a Brad A. Yentzer MD,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: To determine the demographics of acitretin prescribing patterns as an assessment of acitretin use in women of child-bearing potential.
METHODS: We examined National Ambulatory Medical Care Survey (NAMCS) data from the years 1990-2009 to determine demographic data on patients who were prescribed etretinate or acitretin. We used age under 50 as a proxy for childbearing potential.
RESULTS: From 1996-2009, there were an estimated 29 million office visits for psoriasis. Females accounted for 14.3 million of these visits, and 6.5 million (45.6%) of them were under the age of 50. The NAMCS contained only one record of a female patient under the age of 50 being prescribed acitretin from 1996-2009, the years during which acitretin had been available in the United States. This corresponds to an estimated 2.3% of all psoriasis patients prescribed acitretin during this time (20,000 out of 890,000).
LIMITATIONS: The NAMCS estimates national trends based on a large nationwide database. While the use of acitretin in women under 50 is low, the precision of the estimate is limited by the small sample size provided by this database.
CONCLUSIONS: There are now many alternative treatments besides acitretin for women of childbearing potential with moderate to severe psoriasis. Acitretin is used at most infrequently in this population. In females of reproductive potential, acitretin should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.
J Drugs Dermatol. 2013;12(7):799-802.
Objectives: To determine the prescribing pattern of dermatologists and nondermatologists when treating impetigo and the demographics of the patients treated.
Methods: National Ambulatory Medical Care Survey data on office visits for impetigo were analyzed from 1997 to 2007. Patient demographics and the treatments for impetigo were recorded.
Results: During this 10-year period, dermatologists managed an estimated 274,815 impetigo visits and nondermatologists an estimated 3,722,462 visits. Both dermatologists and nondermatologists most frequently prescribed oral antibiotics to treat impetigo. Topical antibiotics were second most common, and a variety of combination treatments were used.
Conclusions: Oral antibiotics are the most common class of medications used to treat impetigo. There is an opportunity for physicians to take advantage of the equally efficacious topical antibiotics for treating impetigo. A shift towards topical antibiotics would likely decrease morbidity (resulting from adverse effects) associated with use of oral agents.
J Drugs Dermatol. 2012;11(4):489-494.
Treatment of Facial Actinic Keratoses With Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) or Ingenol Mebutate 0.015% Gel With and Without Prior Treatment With ALA-PDT
Brian Berman MD PhD, Mark S. Nestor MD PhD, Jessica Newburger DO,
Huynhee Park DO, and Nicole Swenson DO
METHODS: Twenty-four healthy adult male and female subjects who had 4 to 8 clinically visible and discrete actinic keratoses on the face in a contiguous 25cm2 treatment area. Subjects were randomized into one of three treatment groups: 2 treatments with 5-aminolevulinic acid (ALA) and photodynamic therapy (PDT), 1 ALA-PDT treatment and 1 course of ingenol mebutate (ingenol mebutate) 0.015% gel daily for 3 consecutive days, or 1 course of ingenol mebutate gel alone. Actinic keratoses in the treatment field were counted at the baseline visit, and at the completion of the study (day 57 or day 71). At the site of application, local site reactions were graded at each visit.
RESULTS: Subjects in the two ALA-PDT treatment group had a 97.5% mean reduction (P<0.00001) from the number of baseline actinic keratosis; ALA-PDT plus ingenol mebutate gel group had an 86.7% mean reduction (P<0.00001); while subjects in the ingenol mebutate gel alone group had a 91.7% mean reduction from the number of baseline actinic keratoses. The peak composite LSR score was 4.625 for the ALA-PDT group, 10.375 for the ALA-PDT followed by ingenol mebutate gel group, and 12.625 for the ingenol mebutate gel alone group (P=0.0004 and 0.001, respectively).
CONCLUSION: ALA-PDT, ingenol mebutate gel, and a combination of the two treatment modalities are successful topical therapies for the reduction of actinic keratoses on the face. The group of subjects receiving 2 consecutive treatments with ALA-PDT, compared to treatment with ingenol mebutate gel alone or sequentially after one course of ALA-PDT had a significantly lower mean composite LSR score and a non-significant trend for greater efficacy.
J Drugs Dermatol. 2014;13(11):1353-1356.
Objective Melanin Measurements: Review of Novel Dosimetry Guidance Device for Intense Pulsed Light in Aesthetic Treatments
E. Victor Ross MD,a Travis W. Blalock MD,a Douglas Winstanley DO,a Joel L. Cohen MD,b and James J. Childs PhDc| |
METHODS: A handheld meter was applied to non sun-damaged skin on the back of volunteers to measure skin pigmentation prior to treatment with IPL light sources over a range of pulse widths and ascending fluences. Curves for maximum epidermal tolerances as a function of pigmentation were determined. These curves were then tabulated for each pulse width in device software to provide guidance in the selection of fluences. Based on these findings, the device was applied in over 300 patients at a comprehensive laser and cosmetic dermatology center.
RESULTS: A pigment meter evaluation led to treatment parameter guidance in intense pulsed light applications. These suggested ranges for settings based on the melanin index score proved useful, accurate, and safe in applications over a broad range of skin colors and across various anatomic units of the skin.
CONCLUSION: A pigment meter can be used to identify appropriate settings with IPL treatments in order to enhance safety and efficacy when treating epidermal pigmented lesions, vessels, general photodamage and excessive hair (where the principles of selective photothermolysis are applied).
J Drugs Dermatol. 2016;15(4):421-432.
A Case of Co-incident Phenylketonuria, Pemphigus Foliaceus, and Tinea Amiantacea Treated with Tetracycline and Nicotinamide
Noah Scheinfeld, MD| |
Combination of In-Office Chemical Peels With a Topical Comprehensive Pigmentation Control Product in Skin of Color Subjects With Facial Hyperpigmentation
Jeanine Downie MD, a Katie Schneider BS, b Lisa Goberdhan BA, b Elizabeth T. Makino BS CCRA MBA, b and Rahul C. Mehta PhD b| |
Dyschromia is one of the primary complaints for patients with skin of color. Treatments need to achieve a balance between tolerability and efficacy to address existing hyperpigmentation without causing additional damage that could trigger post-inflammatory hyperpigmentation (PIH). An open-label, single-center study was conducted to assess the efficacy of a novel comprehensive pigmentation control serum (LYT2) combined with a series of three very superficial chemical peels (VP) in skin of color subjects. Seventeen female and male subjects aged 36 to 69 years with Fitzpatrick Skin Types III-VI and moderate to severe facial hyperpigmentation were enrolled in the 12-week clinical study. Subjects identified as Asian, Hispanic, African American, or Caucasian ethnicities. Subjects received a series of 3 VP treatments every 4 weeks. LYT2 was applied twice-daily in between VP treatments. Investigator assessments for overall hyperpigmentation, overall photodamage, and skin tone unevenness, as well as standardized digital photography and subject self-assessment questionnaires were conducted at all visits (baseline and weeks 4, 8, and 12). In vivo reflectance confocal microscopy (RCM) of a target lesion was conducted (in a subset of subjects) at baseline and week 12. Fourteen subjects completed the study. The treatment regimen provided statistically significant improvements in all efficacy parameters at weeks 8 and 12 (all P less than equal to 0.03, student’s t-test). Standardized digital photography and RCM images support the improvements in overall hyperpigmentation observed by the investigator. At the end of treatment, the regimen was highly rated by subjects with 100% of subjects (strongly agree/agree) that the combination “decreased the appearance of uneven skin tone and discolorations” and “reduced the appearance of sun damage.” In addition to this clinical study, independent case studies with this combination treatment regimen at a separate study site were also conducted with results that corroborate the formal clinical study findings. The comprehensive results from these studies suggest that the combination of a comprehensive pigmentation control serum with a series of 3 very superficial chemical peels may provide an effective treatment approach for hyperpigmentation in skin of color patients.
J Drugs Dermatol. 2017;16(4):301-306.
Martin Ray MDa and Michael Gold MDb| |
J Drugs Dermatol. 2015;14(11):1268-1271.
Enhanced Full-Face Skin Rejuvenation Using Synchronous Intense Pulsed Optical and Conducted Bipolar Radiofrequency Energy (ELOS): Introducing Selective Radiophotothermolysis
Neil S. Sadick MD FACP FAACS, Macrene Alexiades-Armenakas MD PhD, Patrick Bitter Jr. MD, George Hruza MD, R. Stephen Mulholland MD| |
Objective: The authors report their experience using an ELOS system (Aurora SR, Syneron, Yokneam, Israel) on 108 consecutive patients treated with a series of full-face procedures.
Methods: Patients received 5 full-face treatments every 3 weeks. Each treatment consisted of 1 to 8 full-face and segmental passes. The number of passes, specific wavelength of pulsed optical energy, and RF energy were determined by the patient’s skin type, dyschromia, wrinkle pathology, and presence of a tan. A total of 540 treatments were performed on 108 subjects. All patients had pre- and post-procedural photographs. Results were assessed by double-blinded physician photographic evaluation and patient satisfaction scales.
Results: Overall skin improvement was rated at 75.3%. Overall average wrinkle improvement was 41.2%, with an average Class 1 wrinkle improvement of 64.7%, Class 2 wrinkle improvement of 38.6%, and Class 3 wrinkle improvement of 20.4%. Improvement in skin laxity was rated at 62.9%. Skin texture was reported to improve 74.1%. Improvement in the appearance of pore size was rated at 65.1%. Average improvement in erythema and telangiectasia was 68.4%. Average improvement in hyperpigmentation and dyschromia was 79.3%. Overall patient satisfaction was 92%. The overall minor complication rate, including blistering, crusting, and stripping was 8.3%, and the major complication rate was less than 1%. One small, depressed nasal scar was observed in one patient.
Conclusions: This study demonstrates the safety and efficacy of a new technology using combined optical and conducted bipolar RF energies for noninvasive skin rejuvenation. The results show improvement in wrinkle reduction and amelioration of erythema, telangiectasia, and hyperpigmentation comparable to that reported for other intense pulsed light technologies.
Peter J. Aronson MD and Farah Malick MD| |
Jill Waibel MD, Kenneth Beer MD, Vic Narurkar MDand Tina Alster MD| |
75% Complete Response and 15% Partial Response to Extracorporeal Photopheresis Combined With Other Therapies in Resistant Early Stage Cutaneous T-Cell Lymphoma
Sila Seremet MD,a* Sunil Abhyankar MD,b* Tiffany J. Herd MD,b and Daniel Aires MDb| |
J Drugs Dermatol. 2016;15(10):1212-1216.
Arisa Ortiz MD, Laila Elkeeb MD, Anne Truitt MD,Rasha Hindiyeh MD, Lisa Aquino MD, Minh Tran,Gerald Weinstein MD| |
Background: Current treatments for acne rosacea are often associated with unsatisfactory outcomes and adverse effects.
Objective: To determine the efficacy and tolerability of a new moisturizing lotion for improving the clinical signs and symptoms of mild-to-moderate acne rosacea.
Methods: In a 12-week, open-label study, a moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK124 (0.125%, Pyratine-XR™, Senetek PLC, Napa, CA) was applied twice daily to subjects with mild-to-moderate rosacea. Improvement in the appearances of erythema and papules were assessed by the treating physician. Skin barrier function was measured by transepidmal water loss after treatment. Tolerability and cosmetic outcome were evaluated by patients.
Results: Twenty-one participants completed the study. Overall clinical improvement was observed in 80% of subjects, with most showing mild-to-moderate improvement. Erythema, papule counts, and telangiectasia were reduced. The reduction in TEWL was significant at weeks 4 (p = 0.01), 8 (p < 005), and 12 (p<0.001). Rosacea symptoms (burning, stinging, dryness) were progressively reduced, with reduction in dryness achieving statistical significance at weeks 4 (p = 0.035), 8 (p = 0.037) and 12 (p = 0.016). Treatments were well tolerated and cosmetic outcomes were acceptable. Treatment-induced irritation was not observed.
Conclusion: The new moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK124 shows a continued trend toward improvement of skin barrier function and the appearances of erythema and papules associated with mild-to-moderate rosacea during 12 weeks of treatment.
Whitney P. Bowe MD| |
J Drugs Dermatol. 2014;13(suppl 6):s66-s70.
Stuart J. Anderson MBBS FRACGP FACCO FARGP,a Howard K. Steinman MD,b Jason D. Mazzurco DO MS,c and Anthony J. Dixon PhD MBBSd| |
DESIGN: A prospective multi-center randomized controlled trial. The protocol was approved by the Bond University Human Research Ethics Committee in accord with the TGA’s Clinical Trial Notification Scheme. The trial was registered (12609000025235) on the Australian New Zealand Clinical Trials Registry.
SETTING: Six centers in four states in Australia.
PROTOCOL: Two treatments of ALA PDT, 2 weeks apart for each patient. Controls were observed. Patients were followed up with biopsies of any suspicious lesions every 6 months for 2 years.
MAIN OUTCOME MEASURE(S): Development of new skin cancers.
RESULTS: The trial was suspended after 3 months and closed after 6 months after ethics committee approval was withdrawn on the basis of a breakdown in trial governance. Over the following 2 years, some investigators noted and formally reported the continued occurrence of serious adverse events in excess of those described with other approved cutaneous PDT treatments. USA dermatologists with experience managing AKs with FDA approved ALA products subsequently confirmed prolonged and severe adverse events in 6 of the former trial intervention patients.
DISCUSSION AND CONCLUSIONS: Adverse effects experienced by patients using the investigational ALA PDT appeared more severe than those experienced when an FDA-approved ALA product is used. We believe the former should be further evaluated for safety. It is of concern that this ALA product and lamp could be promoted and used widely in Australia following these reports of significant adverse events and continued lack of TGA approval.
J Drugs Dermatol. 2014;13(1):62-66.
A Bilateral Comparison Study of Pimecrolimus Cream 1% and a Topical Medical Device Cream in the Treatment of Patients With Atopic Dermatitis
Jason J. Emer MD, Amylynne Frankel MD, Andrew Sohn BS, Mark Lebwohl MD| |
J Drugs Dermatol. 2011;10(7):735-743.
Robert Baran, MD and Aditya K. Gupta, MD, PhD, FRCP(C)| |
James Q. Del Rosso DO, Hilary Baldwin MD, Guy Webster MD| |
David Rosmarin MA, Bruce E. Strober MD PhD| |
Before OR After: Is There a Connection Between the Use of Adjunctive Nonmelanoma Skin Cancer Treatments and Subsequent Invasive Tumors?
Emily Stamell Ruiz MD,a Joel L. Cohen MD,b,c
and Adam Friedman MDd
David B. Vasily MD, Mary E. Cerino RN, Ethel M. Ziselman MD, Zeina S. Tannous MD| |
Methods: Clinical studies were conducted on a range of surgical and post-traumatic scars with a 1540 nm erbium:glass fractional laser varying energy, pulse widths, treatment passes, and number of treatments. A histological study was conducted on a postsurgical scar to follow the time course of healing post-treatment and the impact of the fractional treatment on normalization of scar tissue, as compared to baseline histology of the scar.
Results: Histologic findings demonstrated rapid re-epithelialization of the epidermis within 72 hours of treatment. Remodeling of scar tissue with renewal and reorganization of collagen fibers in the dermis was noted two weeks post-treatment. Clinical subjects, with Fitzpatrick skin types II–V, received three to seven treatments with microbeam energies up to 60 mJ/μb and five passes. Relative to baseline, 73% of treated scars improved 50% or more and 43% improved 75% or more. Side effects included mild swelling (95% of subjects), erythema (94%) and purpura (5%), which all resolved within two to three days. Downtime was minimal-to-none for all subjects.
Conclusion: These data illustrate the safety and efficacy of the 1540 nm erbium:glass fractional laser in the treatment of surgical and post-traumatic scars. Practitioners can vary energy and microbeam density in order to tailor the treatment to reflect the individual scar characteristics.
Shaundre Terrell BS, Daniel Aires MD, Eric S. Schweiger MD| |
Observations: This article describes a 26-year-old African American woman with moderate infl ammatory facial acne vulgaris. On examination, she had over 15 infl ammatory papules on her face and post-infl ammatory hyperpigmentation. The patient had a history of treatment failure with the following therapies: topical benzoyl peroxide, topical antibiotics, topical retinoids and oral antibiotics. At presentation, the patient was using a combination topical benzoyl peroxide/clindamycin product in the morning and tazoratene gel in the evening without success. The patient was treated with 20% aminolevulinic acid/blue-light photodynamic therapy spaced monthly for a total of four treatments, a once-daily application of hydroquinone 4% cream and her existing topical regimen. The patient reported signifi cant improvement of infl ammatory acne lesions and post-infl ammatory hyperpigmentation following two treatments with photodynamic therapy and was virtually clear of all acne lesions after the third treatment.
Conclusion: Photodynamic therapy is an emerging remedy for patients with acne vulgaris resistant to standard treatment, particularly in patients with skin of color who are more sensitive to post-infl ammatory hyperpigmentation. In this African-American patient, 20% aminolevulinic acid/blue-light photodynamic therapy was effective in treating facial acne vulgaris.
Wendy E. Roberts MD| |
J Drugs Dermatol. 2014;13(4):472-482.
Steven B. Deliduka MD, Pearl C. Kwong MD PhD| |
We present a case of a 7-year-old boy with bilateral nevus comedonicus who experienced cosmetic improvement with topical tazarotene and calcipotriene cream. This combination represents a novel therapeutic approach to the treatment of this cutaneous abnormality.
Radiesse Nodule of the Lips from a Distant Injection Site: Report of a Case and Consideration of Etiology and Management
Kenneth Robert Beer MD| |
Effective Use of Topical Amitriptyline Hydrochloride 2.5% and Ketamine Hydrochloride 0.5% for Analgesia in Refractory Proctodynia
Julia S. Lehman MD, Gabriel F. Sciallis MD| |
Photodynamic Therapy With Low-Strength ALA,Repeated Applications and Short Contact Periods(40-60 Minutes) in Acne, Photoaging and Vitiligo
Gabriel Serrano MD, Matilde Lorente MD, Madga Reyes MD, Fernando Millan MD, Adrian Lloret MD, Joaquin Melendez, Maria Navarro, Miguel Navarro MD| |
Efinaconazole Solution in the Treatment of Toenail Onychomycosis: A Phase 2, Multicenter, Randomized, Double-Blind Study
Eduardo H. Tschen MD,a Alicia D. Bucko DO,a Norihide Oizumi MS, Hideki Kawabata MS,Jason T. Olin PhD, and Radhakrishnan Pillai PhD| |
Objective: We investigated the efficacy and safety of a solution using a novel topical triazole antifungal, efinaconazole, in distal lateral subungual onychomycosis (DLSO). Methods: Multicenter, randomized, double-blind, vehicle-controlled phase 2 study in mild to moderate toenail DLSO (n=135). Subjects randomized (2:2:2:1 ratio) to receive efinaconazole 10% solution (with or without semiocclusion), efinaconazole 5% solution, or vehicle, once daily for 36 weeks, with one 4-week posttreatment follow-up (week 40). Efficacy assessments included complete cure, mycologic cure, clinical efficacy, and other assessments of overall treatment effectiveness. No efficacy variables were designated as primary.
Results: At follow-up, complete cure was numerically higher in all active groups (16%-26%) compared with vehicle (9%). Mycologic cure rates with efinaconazole 10% semiocclusion, efinaconazole 10%, and efinaconazole 5% were 83%, 87%, and 87%, respectively. Efinaconazole 10% (with or without semiocclusion) demonstrated significantly greater clinical efficacy and treatment effectiveness when compared with vehicle (P=.0088 and .0064; .0056 and .0085, respectively, for both efinaconazole 10% groups). Adverse events were generally similar and mild. Local-site reactions were restricted to few subjects and did not differ meaningfully from those produced by vehicle.
Conclusions: This study provided evidence that once-daily efinaconazole 10% solution (with or without semiocclusion) applied topically for 36 weeks was more effective than vehicle in treating DLSO and was well tolerated. Based on these results, efinaconazole 10% solution was chosen for the phase 3 development program.
J Drugs Dermatol. 2013;12(2):186-192.
Aims: Our aim is to evaluate caregiver opinions regarding the clinical presentations and treatment of psoriasis in African-Americans compared to Caucasians.
Patients/Methods: A survey was sent to 29 dermatologists who are opinion leaders in the field of psoriasis. The survey included a number of questions regarding the characteristics of the patients seen in their practice.
Results: A total of 29 surveys were completed and returned. All of the dermatologists use the extent of disease as a criterion to determine the severity of the disease. Other criteria include scale, thickness, erythema, associated general symptoms, and dyspigmentation. About 66% of the respondents reported the different manifestations of disease, such as more dyspigmentation, thicker plaques, and less erythema in African-Americans. The most common first-line treatments for mild to moderate disease were highpotency topical steroids (68%) followed by topical vitamin D analogues (41%). For moderate to severe disease, the most commonly used first-line treatments were high-potency topical steroids (54%) and phototherapy (46%).
Conclusions: The clinical manifestations of psoriasis in African-Americans are not exactly the same as in Caucasians. Physicians should be aware of the difference in clinical manifestations in African-Americans. Further research and large-scale studies are necessary to elucidate the differences in the clinical presentation, natural course of the disease, and the criteria used for the evaluation of severity among ethnic groups.
J Drugs Dermatol. 2012;11(4):478-482.
Divya Railan MD, Tina S. Alster MD| |
Methods: In a double-blind, placebo-controlled, crossover pilot study, we examined the efficacy of three botulinum toxin preparations (onabotulinumtoxinA, abobotulinumtoxinA, and rimabotulinumtoxinB) following oral supplementation with zinc citrate 50 mg and phytase 3,000 PU, zinc gluconate 10 mg, or lactulose placebo in individuals treated for cosmetic facial rhytids, benign essential blepharospasm, and hemifacial spasm.
Results: In seventy-seven patients, 92% of subjects supplemented with zinc 50 mg and phytase experienced an average increase in toxin effect duration of nearly 30%, and 84% of participants reported a subjective increase in toxin effect, whereas no significant increase in duration or effect was reported by patients following supplementation with lactulose placebo or 10 mg of zinc gluconate. The dramatic impact of the zinc/phytase supplementation on some patients' lives clinically unmasked the study and prompted an early termination.
Conclusions: This study suggests a potentially meaningful role for zinc and/or phytase supplementation in increasing the degree and duration of botulinum toxin effect in the treatment of cosmetic facial rhytids, benign essential blepharospasm, and hemifacial spasm.
J Drugs Dermatol. 2012;11(4):507-512.
Fast and Easy Treatment for Reduction of the Tyndall Effect Secondary to Cosmetic Use of Hyaluronic Acid
Tracee Douse-Dean PA-C, Carolyn I. Jacob MD| |
Saad Al Mohizea MD| |
METHODS: Seven volunteers underwent fixed fractionated CO2 laser treatments at four predetermined days spanning the menstrual cycle.
RESULTS: Two volunteers developed hypopigmentation while the rest had hyperpigmentation. In those who developed PIH, the pigmentation was most severe when done just before or after menstruation.
CONCLUSIONS: Laser induced PIH risk may be influenced by the menstrual cycle.
Alex M. Glazer MD,a Bryan D. Sofen MD,b Darrell S. Rigel MD,c and Jerome L. Shupack MDc| |
Generalized essential telangiectasia (GET) is a notoriously difficult to treat disorder with no current satisfactory treatments. This case and discussion report the use of 6-mercaptopurine (6-MP) as a successful treatment for GET. Moreover, we show that GET may represent a state of increased angiogenesis, a paradigm shift from the current understanding that these telangiectasias represent dilatations of only pre-existing vessels. This new view of GET may drive others to look at novel agents for treatment.
J Drugs Dermatol. 2017;16(3):280-282.
Nina Botto MD and Gary Rogers MD| |
J Drugs Dermatol. 2013;12(5):525-533.
Vic A. Narurkar MD,a Tina S. Alster MD,b Eric F Bernstein MD,c Tina J. Lin PharmD,d and Anya Loncaric MSe| |
BACKGROUND: Fractional photothermolysis (FP) is a popular treatment option for photodamaged skin and addresses shortcomings of ablative skin resurfacing and nonablative dermal remodeling. Previous studies have demonstrated that FP using the 1550nm wavelength has led to improvement of ultrastructural changes and clinical effects associated with photodamaged skin in the deeper dermal structures, while treatment with the 1927nm wavelength has shown clinical effects in the superficial dermis. Both wavelengths produce precise microscopic treatment zones (MTZs) in the skin. The two wavelengths used in combination may optimize the delivery of fractional nonablative resurfacing intended for dermal and epidermal coagulation of photodamage skin.
OBJECTIVES: To evaluate the safety and efficacy of a 1550/1927 Laser System (Fraxel Dual, Solta), using both 1550nm and 1927nm wavelengths in combination for treatment of facial and non-facial photodamage.
METHODS: Prospective, multi-center, post-market study in subjects with clinically identifiable photodamage (N=35) (Fitzpatrick skin types I-IV). Both 1550nm and 1927nm wavelengths were used at each treatment visit. Investigator assessment of the affected area(s) occurred at one week, one month and 3 months after a series of up to four treatments. Severity of adverse events (AEs) were assessed using a 4-point scale (where 0=none and 3=marked). Assessments included erythema, edema, hyperkeratosis, hyper- and hypo-pigmentation, scarring, itchiness, dryness, and flaking. Severity of photoaging, fine and coarse wrinkling, mottled hyperpigmentation, sallowness, and tactile roughness at baseline was assessed using the same scale. Investigators and subjects assessed overall appearance of photodamage and pigmentation based on a 5-point quartile improvement scale at all follow-up visits (where 0=no improvement and 4=very significant improvement [76%-100%]).
RESULTS: There was a positive treatment effect at all study visits, with moderate improvement (average reduction in severity of 21%-43%) observed 3-months after final treatment. Greatest reduction in severity of other benefit areas was at the 3-month follow-up visit, with a 21% and 30% decrease in severity in fine wrinkling and tactile roughness. No AEs or serious AEs were reported. Pain sensation during treatment was tolerable. Anticipated moderate erythema (mean score 1.6±0.5) and mild edema (mean score 0.8±0.7) were transient and resolved within 7-10 days. Anticipated and transient mild dryness (52% of subjects) and flaking (30%) were reported at the 1-week follow-up. There were no incidences of hyperkeratosis, scarring, or itchiness.
CONCLUSION: Treatments using both wavelengths associated with the combined 1550/1927 Laser System were well tolerated with limited, transient anticipated side effects and no serious AEs. Clinical efficacy in the appearance of photodamage and pigmentation was greatest following a series of up to 3 treatments.
J Drugs Dermatol. 2018;17(1):41-46.
Improvement in Atrophic Acne Scars Using Topical Synthetic Epidermal Growth Factor (EGF) Serum: A Pilot Study
Rachel Seidel BAa and Ronald L. Moy MD FAADb,c| |
OBJECTIVE: We evaluated the efficacy of a topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars.
METHODS: A single-center clinical trial was performed on nine self-selected male and female patients with Goodman & Baron grade II-IV atrophic acne scars. Subjects followed a standardized treatment regimen, including twice-daily application of EGF serum to scarred areas over 12 weeks. Subject progress was evaluated at baseline and 4-week intervals by clinical photography, Investigator Global Assessment (IGA), Goodman grade and patient self-assessment. Final patient perceptions were shared by written self-assessment at the end of the study. Before and after photographs were also evaluated by a blind investigator.
RESULTS: Eight subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 2.875 (SEM= .327) to 2.38 (SEM = .375). Mean Goodman grade was reduced from 3.00 (SEM = .309) to 2.75 (SEM = .25). Of the eight pairs of before and after photographs given to a blind investigator, five were correctly chosen as the post-treatment image. Two were assessed as “excellent” (76-100%) improvement and three were assessed as "good" (50-75%) improvement. A one-tailed paired student t-test (α = .05) using blind investigator ratings of scar severity for each before and after photograph yielded a P-value of .0019, confirming the difference as statistically significant. On final self-assessment, all but one patient reported “good” to “excellent” improvement in their scars compared to baseline. 75% of patients who received alternative treatments in prior years reported EGF serum to be more efficacious.
CONCLUSION: These results suggest that topical EGF may improve the appearance of atrophic acne scars, though further study and more objective evaluation measures are required for definitive conclusions to be drawn.
J Drugs Dermatol. 2015;14(9):1005-1010.
An Evaluation of Efficacy and Tolerability of Novel Enzyme Exfoliation Versus Glycolic Acid in Photodamage Treatment
Maria Mekas BSN,a,b Jennifer Chwalek MD,a,c Jennifer MacGregor MD,a,d and Anne Chapas MDa,c| |
METHODS: 75 female subjects with mild to moderate photodamage, all skin types, and ages 31-70 years, were enrolled. In this 12 week study of twice daily self-treatments, patients were assigned to one of 3 groups; Group 1 (n-19) was assigned hydrolyzed roe cream, Group 2 (n=17), 4% glycolic acid, or Group 3 (n-16), 8% glycolic acid plus 2% citric acid. All patients used the same mild face wash and SPF 30 sunscreen throughout the study. Patients were evaluated at weeks 0, 8 and 12 for objective and subjective tolerability, improvement in photodamage by VISIA Complexion Analysis, modified Packman and Gans method, Visual Analog Scale (VAS), and answered an opinion questionnaire.
RESULTS: Group 1 improved in skin clarity from a VAS 44.1 to 55.7 (P=0.0317) at week 12. VISIA mean scores correlated with office evaluation showing improvement in brown spots from 453 to 417 (P = 0.0115) at 12 weeks. Group 2 improved in superficial fine lines at week 8 (-5.9, P=0.0428) and week 12 (-9.1, P=0.0019). Group 3 improved at week 12 in skin clarity (11.5, P = 0.0469) and skin roughness (-13.3, P = 0.0426), and in hyperpigmentation at week 8 (-9.4, P=0.0462) and week 12 (-14.6, P= 0.0019).
CONCLUSION: Topical hydrolyzed roe protein used twice daily improves skin clarity. It has good tolerability with fewer instances of stinging and burning than the other glycolic acid containing creams. Patient’s opinions of the 3 products were similar.
J Drugs Dermatol. 2015;14(11):1306-1319.
Shannon Humphrey MD| |
Onabotulinum Toxin A is the gold standard treatment for temporary dynamic rhytid reduction. Clinicians have observed a long-term and preventive benefit for patients beyond muscle relaxation particularly in patients who receive repeated treatments over time. These changes include progressive reduction of rhytides, prevention of dynamic rhytides, and improvements in skin quality. In this brief paper, we review basic science, clinical, and anecdotal evidence that explores a long-term and potential preventive effect of Onabotulinum Toxin A injections.
J Drugs Dermatol. 2017;16(6 Suppl):s87-90.
Michael H. Gold MD, Amanda D. Heath RN, Julie A. Biron BA, Lori Brightman MD, Mitchel P. Goldman MD,Amy Forman Taub MDc, Martin Braun MD, Suwimon Pootongkam MD and Pravit Asawanonda MD DSc| |
Thomas G. Lewis MD, Ethan D. Nydorf MD| |
Andrew F. Alexis MD MPH| |
C. Stanley Chan MDa and Jeffrey S. Dover MDa-c aSkinCare Physicians, Chestnut Hill, MA bDepartment of Dermatology, Yale University School of Medicine, New Haven, CT cDepartment of Surgery, Dartmouth Medical School, Hanover, NH| |
J Drugs Dermatol. 2013;12(3):366-367.
Fred Laufer MD| |
Jessica Price BS, Monali Bhosle MS, Steven R. Feldman MD PhD, Rajesh Balkrishnan PhD| |
Sung Bin Cho MD, Sang Ju Lee MD PhD, Won Soon Chung MD, Jin Moon Kang MD, Young Koo Kim MD| |
Randomized, Placebo- and Active-Controlled Crossover Study of the Safety and Efficacy of THVD-102, a Fixed-dose Combination of Oxybutynin and Pilocarpine, in Subjects With Primary Focal Hyperhidrosis
David M. Pariser MD FACP FAAD,a Janakan Krishnaraja MD,b Thomas M. Tremblay RN,d R. Michael Rubison PhD,c Ted W. Love MD,d and Benjamin F. McGraw III PharmDd| |
Jennifer Rivard MD, Henry W. Lim MD| |
Sandra Marchese Johnston, MD and Thomas D. Horn, MD, MBA| |
Salma Z. Pothiawala MD MPH, Brooke T. Baldwin MD, Basil S. Cherpelis MD, L. Frank Glass MD, Neil Alan Fenske MD| |
Successful Treatment of Calcium Hydroxylapatite Nodules With Intralesional 5-Fluorouracil, Dexamethasone, and Triamcinolone
Shino Bay Aguilera DO,a Miguel Aristizabal MD,b and Ann Reed DOc| |
J Drugs Dermatol. 2016;15(9):1142-1143.
Cystic Acne Improved by Photodynamic Therapy with Short-Contact 5-Aminolevulinic Acid and Sequential Combination of Intense Pulsed Light and Blue Light Activation
Stuart Melnick MD| |
Clinical Experience Results with Clindamycin 1% Benzoyl Peroxide 5% Gel (Duac®) as Monotherapy and in Combination
Joseph B. Bikowski MD| |
Randomized, Double-Blind, Split-Face Study Evaluating Fractional Ablative Erbium:YAG Laser-Mediated Trans-Epidermal Delivery of Cosmetic Actives and a Novel Acoustic Pressure Wave Ultrasound Technology for the Treatment of Skin Aging, Melasma, and Acne Scars
Macrene Alexiades MD PhDa,b| |
AIM: Evaluate the safety and efficacy of a novel acoustic pressure wave ultrasound device following fractional ablative Er:YAG 2940-nm laser (FELR) and topical agents for rhytids, melasma, and acne scars.
STUDY DESIGN: Randomized, blinded, parallel group split-face side-by-side, controlled study evaluating FELR and topical anti-aging and anti-pigment agents to entire face succeeded by ultrasound to randomized side. Fifteen subjects were enrolled to three treatment arms:rhytids, melasma, and acne scars. Two monthly treatments were administered with 1, 3, and 6 month follow-up. Efficacy was assessed by Comprehensive Grading Scale of Rhytids, Laxity, and Photoaging by Investigator and two blinded physician evaluators. Subject assessments, digital photographs, and reflectance spectroscopic analyses were obtained.
RESULTS: Rhytid severity was reduced from a mean of 3.25 to 2.60 on the 4-point grading scale. Spectrophotometric analysis demonstrated increases in lightness (L*) and reductions in redness (a*) and pigment (b*), with greater improvements on the ultrasound side as compared to FELR and topicals alone. Moderate erythema post-treatment resolved in 7 days and no serious adverse events were observed.
CONCLUSION: In this randomized, paired split-face clinical study, FELR-facilitated TED of topical anti-aging actives with ultrasound treatment is safe and effective with improvement in rhytids, melasma, and acne scars. Statistically significant greater improvement in pigment levels was observed on the ultrasound side as compared to FELR-TED and topical agents alone.
J Drugs Dermatol. 2015;14(11):1191-1198.
Lee Miller MD,1 Vineet Mishra MD,1 Salman Alsaad MD,1 Doug Winstanley MD,1 Travis Blalock MD,1
Chad Tingey MD,1 Jinze Qiu PhD,2 Sara Romine,1 E. Victor Ross MD1
MATERIALS AND METHODS: Under an IRB approved study, eleven subjects with facial photodamage (1 male and 10 female) were enrolled and completed the study. The fractional 1940 nm laser was comprised of a thulium rod pumped by a pulsed alexandrite laser. The fractional patterns were generated by four separate handpieces (two dot (0.48mm and 0.76mm dot-to-dot distance or pitch) and two grid geometries) whereby a larger beam was broken up into smaller microbeams by a microlens system or reflective square grids. The low -pitch circular dot array handpiece, which is used most frequently, has a macro-spot size of 12 mm and a total applied energy of approximately 2-5 J (~ 4-10 mJ per beamlet). Contact skin cooling (5-20degC) was provided via a sapphire window at the distal end of handpiece. Pulses from the dot handpieces were applied with 20% overlap. The microspot size for the dot handpieces was ~ 0.2-0.3 mm. The two grid pattern handpieces included 0.4 mm wide lines with 45% and 0.7 mm wide lines with 65% coverage. Each subject received 3 full-face treatments 4-6 weeks apart. Anesthesia was achieved by 5% lidocaine cream and a cold air chiller. Typical treatments were carried out with two passes. Outcome assessments included changes in pigment, rhytides, laxity, elastosis, and texture, using a diffuse pigmentation scale and the Alexiades-Armenakas Comprehensive Grading Scale of Rhytides, Laxity, and Photodamage. Photographs of each patient from prior to treatment, and 3 months after treatment were analyzed by 3 blinded physician raters. A paired t-test was applied for each category comparing the pre treatment and 3-month post treatment results.
RESULTS: Three months after the final treatment, (a) mean pigment improvement was 21.1%, (b) rhytides were reduced by 14.3%, (c) laxity was reduced by 8.9%, elastosis was reduced by 22.3%, and (e) texture scores were unchanged. Reductions in pigmentation, rhytides, and elastosis were statistically significant (P ≤ 0.05). Clinical downtime was 3-5 days. Pain was variable (mean of 2.8/10) and side effects included two cases of mild focal vesiculation. No long-term side effects were noted. Histological analysis showed focal damage that extended about 200 μm deep to the surface.
CONCLUSION: The 1940nm thulium laser is safe, well tolerated, and results in reduced downtime compared to traditional resurfacing. The study demonstrated that the 1940 nm thulium laser could achieve injury patterns capable of skin rejuvenation.
J Drugs Dermatol. 2014;13(11):1324-1329.
Hernan Pinto MDa and Luis G. Garrido MDb,c| |
J Drugs Dermatol. 2013;12(3):322-326.
Lourdes Rodriguez Fdez.-Freire MD, Amalia Serrano Gotarredona MD, Joes Bernabeu Wittel MD, Agueda Pulpillo Ruiz MD PhD, Rocia Cabrera MD, Manuel Navarrete Ortega MD, Julia Conejo-Mir MD PhD| |
Evaluation of the Safety and Efficacy of a Low Fluence, Picopulsed, Alexandrite Laser in a Pico-Toning Technique With a Diffractive Lens Optic for the Treatment of Photodamage and Textural Improvement in “Off the Face” Applications
Raminder Saluja MD| |
A Rare Case of Non-Hodgkins B-cell Lymphoma in a Psoriatic Patient: A Case Report and Literature Review
Shilpa Gattu MD, Emily M. Becker MD, John Y. M. Koo MD| |
Varun Kalhana and Neil Sadick MDb| |
Biologic drugs, a novel class of agents engineered to target specifc mediators of infammation, and small-molecule inhibitors that pen-etrate the cell membrane to interact with targets inside a cell represent the cutting-edge of pharmacological biomedical therapeutics. Clinical studies have already demonstrated the effectiveness of this new generation of drugs in treating a variety of medical illnesses and conditions that were refractory to traditional treatments. This review aims to describe the latest available or currently in-develop-ment drugs, biologic agents, and small molecule inhibitors for treatment of psoriasis, rosacea, alopecia areata, and atopic dermatitis.
J Drugs Dermatol. 2017;16(12):1224-1228
Case Series: Evaluation of a Liquid Silicone Gel on Scar Appearance Following Excisional Surgery—A Pilot Study
James M. Spencer MD MS| |
Michael Kockaert, MD and Martino Neumann, MD, PhD| |
Catherine D. Buzney MA,a Caitlin Peterman BS,a Ami Saraiya MD,b Shiu-chung Au MD,b
Nicole Dumont,b Ryan Mansfield AS,b and Alice B. Gottlieb MD PhDa,b
METHODS: 258 subjects were included from a database of psoriasis patients seen at Tufts Medical Center (Boston, MA) during 2008-2014. Insurance was classified as primarily private or public (Medicare or MassHealth/Medicaid). Patients required a minimum of two consecutive visits per treatment and at least 8 weeks within one of four treatment categories: biologics, oral systemics/ phototherapy, combined biologics and oral systemics/phototherapy, or topicals only. Primary endpoint was the Simple-Measure for Assessing Psoriasis Activity (S-MAPA) calculated by multiplying Physician Global Assessment by Body Surface Area. S-MAPA<3 constituted absolute clearance. Insurance type was evaluated as a predictor of prescribed treatment categories, maximum S-MAPA
improvement from baseline, and total drugs used per treatment course (“drug-switching”).
RESULTS: 80.2% (n=207) and 19.8% (n=51) had primarily private and public insurance, respectively. 69.6% with private insurance were prescribed biologics versus 66.7% (public insurance) (P=0.689). 54% (private) versus 49% (public) achieved clearance (P=0.514). However, S-MAPA decreased 78.35% from baseline in those with private insurance compared to 61.48% (public) (P=0.036). On average, privately insured patients used at least twice as many same-category treatments, most commonly biologics, than publicly insured individuals (P=0.003). Drug-switching was significantly associated with clearance (P=0.024). Multivariate analysis demonstrated no significant differences in prescribed treatment categories, drug efficacy, clearance, S-MAPA, or drugswitching with respect to patient age.
CONCLUSIONS: Treatment categories were comparably prescribed between insurance subgroups. However, privately insured patients achieved significantly greater degrees of clearance and switched between more medications within biologic and systemic categories, potentially explaining their overall improved therapeutic response. Further studies including cost-analysis could clarify any difference in the effectiveness of prescribed therapy for these two patient populations.
J Drugs Dermatol. 2015;14(2):119-125.
Ablative Fractionated CO2 Resurfacing Yields Excellent Result for Severely Atrophic Traumatic Scar on the Face
J. Daniel Jensen MD, Cooper Keane MD, Conway C. Huang MD, and Marian E. Northington MD| |
J Drugs Dermatol. 2014;13(7):861-862.
Porcia B. Love MDa and Roopal V. Kundu MDb| |
J Drugs Dermatol. 2013;12(4):403-409.
Jennie B. Nally MD, Diane S. Berson MD| |
Scott W. Dunbar MDa and David J. Goldberg MDa,b| |
J Drugs Dermatol. 2015;14(11):1229-1238.
Erling Thom PhD| |
Amongst various treatment methods and substances, oral supplementation with a specific bioavailable proteoglycan stands out as a promising new therapeutic treatment method.
J Drugs Dermatol. 2016;15(8):1001-1004.
Lauren Meshkov Bonati MDa and Sabrina Guillen Fabi MDb| |
BACKGROUND: There is growing demand for cosmetic treatments in the younger population, yet counseling and treating this age group can be difficult to justify.
OBJECTIVE: Chronologic changes that cause noticeable signs of aging are discussed within each age group. Age-appropriate cosmetic preventions and interventions are therefore recommended.
METHODS: A PubMed search was performed for high quality trials and evidence based reviews on the basic science of aging, as well as on cosmetic modalities and their histological, biochemical, and clinical effects.
RESULTS AND CONCLUSIONS: Specific age-related changes occur with each decade of life. A complete understanding of when these physiologic changes occur helps determine age-appropriate cosmetic counseling, preventions, and interventions.
J Drugs Dermatol. 2017;16(6 Suppl):s81-83.
Sarah A. Malerich BS,a,b Amer H. Nassar MD,b Andrew S. Dorizas MD,b,d Neil S. Sadick MDb,c| |
J Drugs Dermatol. 2014;13(11):1331-1335.
J Drugs Dermatol. 2011;10(5):494-498.
Jean-Paul Ortonne MD| |
Safety and Efficacy of Two Anti-Acne/Anti-Aging Treatments in Subjects With Photodamaged Skin and Mild to Moderate Acne Vulgaris
Background: Although reliable prevalence data are not available, adult acne is thought to be somewhat common, and it is not unusual for patients
to have acne as well as early signs of skin aging. A novel anti-acne/anti-aging formulation (Treatment A) has been developed for daily use by
patients to address both signs of skin aging and facial acne vulgaris. The novel, non-prescription formulation includes several ingredients shown
to target factors underlying the pathogenesis of acne vulgaris while also addressing multiple components in the pathophysiology of skin aging.
Methods: A blinded, randomized, split-face study was conducted to evaluate and compare the tolerability and efficacy of the novel anti-acne/ anti-aging product in subjects with photodamaged skin and acne vulgaris relative to tretinoin cream 0.025% (Treatment B). All subjects also were given supportive skincare, consisting of a cleanser, moisturizer, and sunscreen. Each treatment was assessed for its effects on subjects' appearance, lesion count reductions, and tolerability.
Results: Treatment A produced statistically significantly greater improvements in skin tone evenness, skin tone clarity, and blemishes and blotchiness. There were also statistically greater reductions in total lesion count for acne patients on the side of the face treated with Treatment A compared to Treatment B; Treatment A was also associated with early (day 2) improvement in skin tone evenness and clarity, tactile skin smoothness, and blemishes and blotchiness. Both treatments demonstrated favorable tolerability.
Conclusion: The novel topical anti-aging/anti-acne therapy (Treatment A) within a comprehensive skin care regimen of cleanser, moisturizer, and sunscreen may maximize efficacy and tolerability and contribute to our armamentarium for treating both photodamage and acne at the same time.
J Drugs Dermatol. 2012;11(6):737-740
Brooke Bair DO and David Fivenson MD| |
Objective and Methods: Sodium thiosulfate has been used to systemically treat calciphylaxis with little to no adverse effects. We report two cases of ulcerative calcinosis cutis which were refractory to multiple topical treatments and did not improve with correction of underlying electrolyte abnormalities.
Results: Both cases showed an excellent response to topical 25% sodium thiosulfate compounded in zinc oxide.
Limitations: We are limited by a small sample size (n=2) in this case series.
Conclusions:We recommend topical sodium thiosulfate 25% as an alternative treatment for dystrophic calcinosis cutis.
J Drugs Dermatol. 2011;10(9):1042-1044.
Linda Stein Gold MD| |
J Drugs Dermatol. 2015;14(6):567-572.
Cindy Berthelot MD, Allison Rivera MD, Madeleine Duvic MD| |
Delayed Onset Nodules From Liquid Injectable Silicone: Report of a Case, Evaluation of Associated Histopathology and Results of Treatment With Minocycline and Celocoxib
Kenneth Beer MD| |
Adam J. Luber BA, Shaheen H. Ensanyat BS, and Joshua A. Zeichner MD| |
J Drugs Dermatol. 2014;13(2):130-134.
Effect of Field Treatment of Actinic Keratosis With Ingenol Mebutate Gel on the Identification of Lesions for Biopsy
Miriam S. Bettencourt MD| |
J Drugs Dermatol. 2015;14(8):813-818.
Joseph F. Fowler Jr. MD FAAD| |
J Drugs Dermatol. 2014;13(10):1180-1183.
Re-evaluating Treatment Targets in Acne Vulgaris: Adapting to a New Understanding of Pathophysiology
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(suppl 6):s57-s60.
Soloman Shockman MD, Kapila V. Paghdal MD PharmD, George Cohen MDb| |
Brian Berman MD PhDa,b and Eggert Stockfleth MD PhDc| |
J Drugs Dermatol. 2016;15(5):535-542.
Selective Non-contact Field Radiofrequency Extended Treatment Protocol: Evaluation of Safety and Efficacy
Amir Moradi MDa and Melanie Palm MDb| |
METHODS:Twenty-five subjects enrolled in the IRB approved multi-center study to receive four weekly 45-minute RF treatments to the abdomen and love handles. Standardized digital photographs and circumference measurements were taken at baseline and at the 1- and 3-month follow-up visits. Biometric measurements including weight, hydration and body fat were obtained at baseline and each study visit. A subset of 4 subjects were randomly selected to undergo baseline serum lipid and liver-related blood tests with follow-up labs taken: 1 day post-treatment 1, 1 day post-treatment 4, and at the 1- and 3-month follow-up visits.
RESULTS: Twenty-four subjects (22 female, 2 male), average age of 47.9 years (30-69 years), completed the study. The data of the twenty-four subjects revealed a statistically significant change in circumference P<.001 with an average decrease in circumference of 4.22cm at the 3-month follow-up visit. Lab values for the subset of 4 subjects remained relatively unchanged with only minor fluctuations noted in the serum lipid values in two of the subjects. Three independent evaluators viewed pre-treatment and 3-month post treatment photographs to determine which photo was the after photo. The evaluators were able to correctly identify the post treatment photos with an 88% accuracy rate. Treatments were well tolerated by all subjects. No study related adverse events were reported.
CONCLUSION: This study found that an extended treatment protocol using a selective RF device is a safe and effective method for the reduction of circumference and improved contouring of the abdomen and love handles.
J Drugs Dermatol. 2015;14(9):982-985.
Ramsin Joseph Yadgar BS,a and Adam J. Friedman MDa,b| |
William P. Werschler MD FAAD, Susan Weinkle MD FAAD| |
Steven R. Feldman MD PhD, Linda H. Stein Gold MD, Joshua A. Zeichner MD| |
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 2 AMA PRA Category 1 Credits.
Scott Fretzin MD, Jeffrey Crowley MD, Loretta Jones FNP-C, Melodie Young MSN RN ANP-C, Jeffrey Sobell MD| |
Maira E. Herz Ruelas MD, Minerva Gómez MD, Oliverio Welsh MD DrSc, Horacio Decanini Arcaute MD, Jorge Ocampo-Candiani MD| |
Joesph F. Sobanko MD,a Jonathan Okman BA MBA,b and Christopher Miller MDa| |
J Drugs Dermatol. 2013;12(suppl 10):s154-s155.
J Drugs Dermatol. 2012;11(7):826-829.
J Drugs Dermatol. 2012;11(9):1053-1058.
Fractional, Nonablative Q-switched 1,064-nm Neodymium YAG Laser to Rejuvenate Photoaged Skin: A Pilot Case Series
Methods: Seven healthy female subjects (mean ±standard deviation age, 53.8 ± 10.0 years) with visible signs of facial and neck skin aging were treated with fractional, nonablative Q-switched 1,064-nm Nd:YAG laser device (Pixel QS Nd:YAG; Alma Lasers Ltd, Caesarea, Israel). Treated areas were the face, including the periorbital and perioral regions (particularly the upper lip), neck, and chest. Treatments consisted of 3 sessions at 2- to 4-week intervals. Follow-up was performed monthly following the final treatment. The Alexiades-Armenakas Comprehensive Grading Scale of Skin Aging was employed to assess efficacy. Pain ratings were recorded by 10-point visual assessment scoring.
Results: Employing the validated, quantitative grading scale for rhytides of the face and neck, a 0.29 grade improvement, or 11.3% improvement, over baseline grade was observed in the 7-subject cohort that completed follow-up following a mean of approximately 2 treatments at approximately 1-month follow-up. No pain and rapidly resolving minimal erythema were noted in all subjects during treatment.
Conclusion: The results of this pilot case series suggest that the treatment with the fractional, nonablative Q-switched 1,064-nm Nd:YAG laser device significantly improves superficial rhytides. With its outstanding safety, it seems to be particularly suitable for the treatment of sensitive areas, such as the periorbital region, lips, neck, and chest. The Q-switched Nd:YAG laser is a facile, safe, and fast treatment for aesthetic skin rejuvenation.
J Drugs Dermatol. 2012;11(11):1300-1304.
Kelley Pagliai Redbord MD, C. William Hanke MD| |
J Drugs Dermatol. 2012;11(9):1117-1118.
Fractionated Delivery Systems for Difficult to Treat Clinical Applications: Acne Scarring, Melasma, Atrophic Scarring, Striae Distensae, and Deep Rhytides
Amy F. Taub MD| |
Frank C. Victor, Alice B. Gottlieb| |
A 2940 nm Fractional Photothermolysis Laser in the Treatment of Acne Scarring: A Pilot Study in China
Hui Deng MD PhD, Dingfen Yuan MD, Chunlin Yan MD, Xiaoxi Lin MD PhD, Xu’an Ding MD| |
Methods: Twenty-six patients with moderate-to-severe atrophic scarring were treated with a 2940 nm-wavelength fractional photothermolysis laser.
Results: All patients had encouraging results. Both skin elasticity and moisture content increased significantly after five treatments. In post-treatment evaluations, both the patients treated, as well as an independent group of physicians each scored the atrophic scar improvement as significant.
Conclusion: The 2940 nm fractional photothermolysis laser is safe and effective in the treatment of acne scarring.
Steven H. Dayan MD,a Rachel N. Pritzker MD,b and John P. Arkins BSc
aClinical Assistant Professor, University of Illinios Department of Otolaryngology, Chicago, IL bDepartment of Medicine, Division of Dermatology, John H.Stroger Jr. Hospital of Cook Country, Chicago, IL cDeNova Research, Chicago, IL
J Drugs Dermatol. 2012;11(12):e76-e79.
Geraldine Cheyana Ranasinghe BS and Adam J. Friedman MD| |
The seborrheic keratosis is the most common benign skin tumor of middle-aged and elderly adults, affecting nearly 83 million individuals in the US alone. Although these are benign lesions, many patients still undergo some form of treatment. Clinicians are frequently presented with a challenge when determining whether to remove a seborrheic keratosis, and which treatment modality to use when doing so. The most commonly used method of removal is cryotherapy, however there are numerous other options that can be employed with varying degrees of efficacy. In this article, we highlight the use of topical keratolytics, vitamin D analogues, and lasers, to name a few. We also address potential side effects associated with these treatment options, as well as discuss patients’ preferences and concerns. We conclude with the most recent advances in topical treatments currently under clinical investigation, and offer treatment strategies aimed at maximizing patient satisfaction.
J Drugs Dermatol. 2017;16(11):1064-1068.
Martin Braun MD| |
Neil S. Sadick MD| |
A Randomized Controlled Study of Combination Therapy With Alefacept and Narrow Band UVB Phototherapy (UVB) for Moderate to Severe Psoriasis: Efficacy, Onset, and Duration of Response
Objective: To assess the efficacy of alefacept in combination with nbUVB phototherapy compared to alefacept alone in subjects with moderate to severe psoriasis.
Methods: Ninety-eight adults with moderate to severe psoriasis were randomized to treatment with alefacept 15 mg intramuscularly (IM) once weekly for 12 weeks alone or in combination with three times weekly nbUVB treatments in this prospective, open-label, assessor-blinded, randomized, multicenter, parallel-group, 36-week study.
Results: A statistically significantly greater proportion of subjects in the alefacept plus nbUVB arm achieved the primary endpoint of PASI 75 at week 16 compared to subjects in the alefacept alone arm (44.9% vs 22.5%, P=0.032). Secondary outcomes were also in favor of the alefacept plus nbUVB group, including the proportion of subjects achieving a Physician Global Assessment (PGA) score of clear or almost clear at any time during the study (59.2% vs 34.7%, P=0.026) and reduction in percent body surface area (BSA) involved with psoriasis at week 16 (13.4% vs 8.0%, P<0.001). The onset of clinical response was significantly faster in the combination therapy group compared to monotherapy (mean time to PASI 75: 82 vs 107 days, P=0.007). Both treatments were generally well tolerated.
Limitations: Open-label, assessor-blinded study without a phototherapy-only treatment arm.
Conclusion: The addition of nbUVB to treatment with alefacept significantly enhanced and accelerated the clinical benefits of alefacept therapy and was generally safe and well-tolerated.
J Drugs Dermatol. 2012;11(8):929-937.
In Vivo Histological Evaluation of Non-Insulated Microneedle Radiofrequency Applicator With Novel Fractionated Pulse Mode
Yoram Harth MD FAADa,b and Ido Frank BSc MBAb| |
METHODS: After Ethics Committee approval, one female pig (Type Large white X Landrace, 34 Kg) was chosen for the study. The animal was anesthetized using Ketamine, Xylazin and Isofluran. The EndyMed PRO, Intensif applicator (was used for treatment with different needle depth penetration (1mm-3.5 mm) and in multiple energy settings. Six mm punch biopsies were harvested for histological analysis at the following time points: immediately after the treatment, 4 days after the treatment and 14 days after the treatment. H&E and Masson-Trichrome stains were processed.
RESULTS: Visual inspection of the treated skin, immediately after the treatment, revealed arrays of pinpoint erythematous papules surrounded by undamaged epidermal tissue. Treatment field showed no sign of bleeding. Mild to moderate Erythema and Edema developed a few minutes after the treatment, varying according to the total energy delivered. The histologies taken 4-day after therapy showed in all energy settings, dry micro crusts over the treatment zones, with full healing of epidermis. In the 14-day specimens there was a replacement of the crusts/debris by a normal looking stratum corneum with complete healing of epidermis and dermis.
DISCUSSION: The current in vivo study confirms that the EndyMed PRO Intensif applicator effective and predictable tool to create cylindrical micro zones of coagulation in the papillary and reticular dermis with minimal damage to the epidermis. The histologies taken 4 days and 14 days after treatment show rapid epidermal renewal with predictable volume of coagulation in dermis related to the length of the needle and the power used. Coagulation of capillaries during treatment allows a dry treatment field. The predictability of the effect and minimal downtime may offer a significant advantage over treatments with ablative fractional lasers of insulated RF microneedles.
J Drugs Dermatol. 2013;12(12):1430-1433.
Tiffani K. Hamilton MD and Cheryl M. Burgess MD| |
Amy Forman Taub, MD| |
Thirty-two consecutive patients of Fitzpatrick skin types I- III underwent 1 to 7 treatments with intense pulsed light. Patients were assessed clinically and photographically. In addition, patients completed a detailed questionnaire regarding their response to treatment.
Following treatment, eighty-three percent of patients had reduced redness, 75% noted reduced flushing and improved skin texture, and 64% noted fewer acneiform breakouts. Complications were minimal and transitory.
It appears that intense pulsed light is an effective treatment for the signs and symptoms of rosacea and represents a new category of therapeutic options for the rosacea patient.
Rhytides, Laxity, and Photoaging Treated with a Combination of Radiofrequency, Diode Laser, and Pulsed Light and Assessed with a Comprehensive Grading Scale
Macrene Alexiades-Armenakas MD PhD| |
Frequency of Thromboembolic Events Associated With Thalidomide in the Non-Cancer Setting: A Case Report and Review of the Literature
Sabrina Guillen Fabi MD, Carlotta Hill MD, Joslyn N. Witherspoon MD MPH, Susan L. Boone MD,Dennis P. West PhD FCCP CIP| |
Charles Lynde MD| |
Lilla Landeck MD, Sonja Sabath,a Swen Malte John MD, Guenther Gediga PhD, Nanna Y. Schurer MD| |
Terrence Colin Keaney MD| |
Gender plays a significant role in determining facial anatomy and behavior, both of which are key factors in the aging process. Understanding the pattern of male facial aging is critical when planning aesthetic treatments on men. Men develop more severe rhytides in a unique pattern, show increased periocular aging changes, and are more prone to hair loss. What also needs to be considered when planning a treatment is what makes men beautiful or “man-some”. Male beauty strikes a balance between masculine and feminine facial features. A hypermasculine face can have negative associations. Men also exhibit different cosmetic concerns. Men tend to focus on three areas of the face – hairline, periocular area, and jawline. A comprehensive understanding of the male patient including anatomy, facial aging, cosmetic concerns, and beauty are needed for successful cosmetic outcomes.
J Drugs Dermatol. 2017;16(6 Suppl):s91-93.
A Novel Skin Cream Containing a Mixture of Human Growth Factors and Cytokines for the Treatment of Adverse Events Associated with Photodynamic Therapy
Michael H. Gold MD, Julie Biron| |
Comparison of Pre- and/or Postphotodynamic Therapy and Intense Pulsed Light Treatment Protocols for the Reduction of Postprocedure-Associated Symptoms and Enhancement of Therapeutic Efficacy
Barbara D. Garcia MD, Mitchel P. Goldman MD, Michael H. Gold MD| |
Robert Baran MD, Luc Thomas MD PhD| |
The Clinical Effects of Zinc as a Topical or Oral Agent on the Clinical Response and Pathophysiologic Mechanisms of Acne: A Systematic Review of the Literature
Staci Brandt PA-C MSMR MBA| |
J Drugs Dermatol. 2013;12(5):542-545.
Treatment of a Symptomatic Dermatofibroma With Fractionated Carbon Dioxide Laser and Topical Corticosteroids
Audrey S. Wang MD,a Larissa Larsen MD,a Shurong Chang MD PhD,a Tiffany Phan BA,a Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2013;12(12):1483-1484.
Irene J. Vergilis-Kalner MD, David J. Mann MD, Justin Wasserman MD, Vesna Petronic-Rosic MD MSc,Maria M. Tsoukas MD PhD| |
Heather Woolery-Lloyd MD FAAD, Mohamed L. Elsaie MD MBA FAAD, Nidhi Avashia BS| |
James M. Spencer MD| |
Kalindi Raval PharmD, Jennifer H. Lofland PharmD MPH PhD, Heidi C. Waters MS MBA, Catherine Tak Piech MBA| |
J Drugs Dermatol. 2011;10(2):189-196.
D. K. Damle MD DNB, P. M. Mahajan MD, S. N. Pradhan MD, V. A. Belgaumkar MD, A. P. Gosavi MD, S. N. Tolat MD, N. R. Gokhale MD, C. B. Mhaske MD| |
Methods: This assessment series included 18 patients with a conﬁ rmed diagnosis of actinomycetoma, and who had shown a poor response to previous treatments. Patient received a combination therapy of the Welsh regimen (amikacin along with cotrimoxazole) to which rifampicin was added as a third drug. Clinical evaluation included radiology and laboratory investigations.
Results: Sixteen patients out of 18 completed the combination therapy, which lead to remission. Two patients were lost to follow-up. Of the 16 patients in remission, no recurrence was observed during a follow-up period of up to 18 months.
Long-term Comparison of a Large Spot Vacuum Assisted Handpiece vs the Small Spot Size Traditional Handpiece of the 800 nm Diode Laser
Nour J.Youssef MD,a Alain G.Rizk MD,a Omar A. Ibrahimi MD PhD,b,c and Zeina S.Tannous MDa,c| |
J Drugs Dermatol. 2017;16(9):893-898.
Abbas Rasi MD, Leila Tajziehchi MD| |
Veronica Russo MD MPH and Ali Alikhan MD| |
CASE: A 55-year-old African American male with a several year history of severe HS, recalcitrant to multiple prior treatments, was treated with a 12 week course of anakinra 100 mg subcutaneously daily. After 3 months of therapy, minimal change was observed, and the patient strongly preferred to cease therapy due to lack of improvement and pain associated with daily injections.
CONCLUSION: Our case of severe HS proved refractory to anakinra. Tolerance of this therapy may be a limiting factor for some patients due to necessity for daily injections.
J Drugs Dermatol. 2016;15(6):772-774.
Pulsed Dye Laser for the Treatment of Hypergranulation Tissue with Chronic Ulcer in Postsurgical Defects
Steven Q. Wang MD, Leonard H. Goldberg MD FRCP| |
Plasmapheresis for Refractory Urticarial Vasculitis in a Patient with B-Cell Chronic Lymphocytic Leukemia
Jessica L. Alexander MD, Amer N. Kalaaji MD, James M. Shehan MD, Benjamin K. Yokel MD, Mark R. Pittelkow MD| |
Mehods: We report a case of refractory urticarial vasulitis developing in association with B-cell chronic lymphocytic lukemia in a 46- year-old man. We also reviewed the literature to identify other cases of urticarial vasculitis managed with this therapeutic modality.
Results: The diesease progressively improved during 6 treatments with palsmapheresis (plasma exchange). In additional cases indentified in the literatrue, plasmaphersis was generally effective and well tolerated.
Conclusion: On the basis of these findings, we propose that plasmapheresis be considered a treatment option for refractory urticarial vasculitis.
Carey Kim MS,a Pantea Hashemi MD,b Michael Caglia MD,c and Kenneth Shulman MDd| |
CASE: A patient with a 5 year history of EV failed to respond to a 6 week course of 5% imiquimod on the forehead and was subsequently treated with a 3 day course of 0.015% Picato gel which resulted in significant clinical improvement. A one month follow-up examination showed no reoccurrence of the lesions with the patient reporting continued satisfaction of the outcome.
CONCLUSION: Our case provides insight into the potential use of ingenol mebutate for EV patients unresponsive to traditional medical treatments.
J Drugs Dermatol. 2016;15(3):350-352.
Sara M. James BS,a Dane E. Hill MD,a and Steven R. Feldman MD PhDa,b,c| |
OBJECTIVE: To identify the most common and most costly (from the payer perspective) drugs used in the treatment of psoriasis.
METHODS: We analyzed patient data from a large claims-based database in order to identify the most common and most costly medications used in the treatment of psoriasis from 2010 to 2014.
RESULTS: The three most common psoriasis medications, accounting for 81.1% of all psoriasis medications, were topical corticosteroids. The three most costly drugs, accounting for only 9.6% of all psoriasis medications, were biologics, accounting for 86% of the cost of psoriasis medications.
CONCLUSIONS: Biologic agents are used far less commonly in the treatment of psoriasis than topical treatments. Despite the relatively small number of patients using biologic agents, biologics are responsible for a large proportion of the cost of psoriasis pharmacotherapy.
J Drugs Dermatol. 2016;15(3):305-308.
The Impact of Inoperable Advanced Basal Cell Carcinoma: the Economic, Physical, and Psychological Burden of the Disease
Arielle W. Haves BA, Panta Rouhani Schaffer MD PhD MPH, and John A. Carucci MD PhD| |
J Drugs Dermatol. 2013;12(suppl 10):s151-s153.
Henry Ford Hospital Dermatology Experience with Levulan Kerastick and Blue Light Photodynamic Therapy
Jennifer Rivard MD, David Ozog MD| |
Ricardo Ruiz-Rodriguez MD PhD, Laura López-Rodriguez MD| |
Leon H. Kircik MD, Neh Onumah MD, Joshua A. Zeichner MD, Elena Sotiriou MD PhD, Christina Goussi MD, Aimilios Lallas MD, Eleni Chovarda MD, Zoe Apalla MD, Elisabeth Lazaridou MD PhD, Demetris Ioannides MD PhD| |
Martha H. Viera MD, Caroline V. Caperton MD MSPH, Brian Berman MD PhD| |
Occurring with higher proportions in skin of color, keloid formation is seen in individuals of all races, with the lowest incidence in albinos. Interestingly, prevalence of keloids is correlated to skin pigmentation, with dark-skinned individuals suffering disproportionately. Many factors are taken into consideration when deciding which modalities to use in the treatment of keloids, including size, anatomical site, cause, symptoms, duration of treatment and not least importantly, pigmentation of the patient. In patients with skin of darker color it is necessary to communicate the effects these treatments may have on epidermal pigmentation to the patient. Of course, the best treatment for keloids remains prevention. Physicians should be alert to delays in wound healing, persistent erythema, or pruritus as impending symptoms of possible keloid formation and make all reasonable attempts to reduce inflammation and tension on the skin with appropriate methods.
J Drugs Dermatol. 2011;10(5):468-480.
Mitalee P. Christman MD,a Daniel Belkin MD,b Roy G. Geronemus MD, a,band Jeremy A. Brauer MDa,b| |
An Open-label, Split-face Study Comparing the Safety and Efficacy of LevulanKerastick (Aminolevulonic Acid) Plus a 532 nm KTP Laser to a 532 nm KTP LaserAlone for the Treatment of Moderate Facial Acne
Neil Sadick MD FACP FAACS| |
Susan C. Taylor MD| |
The seborrheic keratosis (SK), which is ubiquitous throughout all populations, is a benign tumor of the skin. SKs are among the top 20 dermatologic conditions treated by dermatologists. They have been reported to occur in individuals of all ages including children as young as age 15 years. Familial cases of SKs have been described with an autosomal dominant inheritance pattern. Mutations of the fibroblast growth factor receptor 3 gene (FGFR3) and the gene encoding for phosphoinositide 3-kinase (PIK3CA) have been demonstrated in SKs. In addition to a genetic predisposition, independent risk factors include advancing age and ultraviolet light exposure. It has been proposed that these two risk factors may also contribute to the development of SKs caused by the genetic mutation in FGFR3 gene, which is involved in regulating cell growth, differentiation, migration, and wound healing. The classic description of a SK is a papule or plaque with a soft, friable, hyperkeratotic surface, or a macule with a fine granular appearance. Variants include the stucco seborrheic keratosis and dermatosis papulosa nigra (DPN). Although diagnosed clinically, mimickers of SKs are well known with melanoma being the most concerning. Treatment of SKs is primarily procedural with new treatments in development.
J Drugs Dermatol. 2017;16(5):419-424.
Edwardo Tschen, MD and Terry Jones, MD| |
Lilia M. Correa-Selm MD,a Mahin Alamgir MD,b Babar K. Rao MDc| |
Over a decade ago, the FDA approved biologics for psoriasis, which changed how the disease is treated and, in most cases, has a significant positive impact on the lives of patients. Side effects primarily identified during the investigational and research phase led to the development of specific guidelines for treatment. The treatment guidelines have been amended to incorporate better understandings of side-effects over the years that the disease has been treated. In this study, we focused on a chart review that included assessing the current guidelines and their alignment with modern patient management and the recent side effects presented. This life-cycle evaluation included over 100 patients, management of their treatment, laboratory abnormalities, criteria for choosing or changing to a different biologic, and the effects of the treatments management throughout the years. The review identified some recommended changes in the application and treatment of psoriasis with biologics. To further evidence our findings, we hope to expand this study to a larger scale with more patients.
J Drugs Dermatol. 2017;16(3):215-217.
Joseph B. Bikowski, MD; and Mitchel p. Goldman, MD| |
Oscar Hevia MD| |
Magdalene Dohil MD, Leslie Baumann MD, Hema Sundaram MD, Jason Emer MD| |
Providing optimal patient outcomes continues to be a challenge in the treatment and management of dermatologic conditions. Most physicians and patients are interested in doing everything possible to optimize the treatment of their skin disease. This is especially important in treating patients with chronic disorders such as eczema, acne, psoriasis, rosacea, photodamage and the negative effects of aging. Physicians and patients often explore the therapeutic benefits of natural ingredients as alternative or complementary treatments to conventional methods. It is important that dermatologists remain up-to-date on the research and new advances in skin care products with natural ingredients.
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 category 1 CME Credit.
Allison P. Weinkle BS,a Bryan Sofen MD,b and Jason Emer MDc| |
J Drugs Dermatol. 2015;14(11):1215-1228.
Nicole Van Buren MS and Tina S. Alster MD| |
Recent U.S. population statistics reveal dramatically shifting demographics that would anticipate a likely increase in this percentage. U.S. Census Bureau data projects that by 2050, people of color are expected to become the majority, comprising 54% of the U.S. population, with Latinos accounting for 30%, African Americans 15%, and Asians 9.2%. The rising popularity of cutaneous laser surgery as an accepted therapy for various skin pathologies, coupled with the diverse face of the patient population, has led to increased demand for laser treatment of darker skin tones.
Although difficult, effective laser therapy in patients with darker skin phototypes can be achieved. When determining a treatment protocol for an individual patient, the proper laser energy and wavelength are important in ensuring a substantial margin of safety while still achieving satisfactory results.
Photorejuvination of Facial Skin with Topical 20% 5-Aminolevulinic Acid and Intense pulsed Light Treatment: A Split-Face Comparison
Tina S. Alster MD, Elizabeth L. Tanzi MD, Esperanza C. Welsh, MD| |
L. Rusciani MD, A. Paradisi MD, C. Alfano MD, S. Chiummariello MD, A. Rusciani MD| |
Donald V. Belsito, MD| |
Central Serous Chorioretinopathy Associated With Topical Corticosteroids in a Patient With Psoriasis
Navid Ezra MD,a Mehran Taban MD,b Daniel Behroozan MDa,c,d| |
Background: Central serous chorioretinopathy (CSC), also known as central serous retinopathy (CSR), is a visual impairment, often temporary, usually in a single eye, which mostly affects males in the age group of 20 to 50 but may also affect women. CSC occurring after prolonged use of topical steroids in a patient with psoriasis is a novel complication in the English literature.
Observations: We describe a case of a 25-year-old male, with a 15-year history of corticoid ointment use for psoriasis, who presented with loss of vision secondary to CSR.
Conclusions: All topical steroid treatments were discontinued and the patient recovered his vision completely. Although topical corticosteroids are frequently utilized for psoriasis management with a low rate of complication, clinicians should be familiar with this rare yet distressing condition. Furthermore, patients with increased production of endogenous corticosteroids (e.g., those with Cushing's syndrome, hypertension, or obstructive sleep apnea) should be warned of the potential of chorioretinopathy following prolonged use of topical corticosteroids
J Drugs Dermatol. 2011;10(8):930-933.
Randomized, Double-Blind, Split-Face Study to Compare the Irritation Potential of Two Topical Acne Formulations Over a 21-Day Treatment Period
Leon H. Kircik MD,a Varsha Bhatt PhD,b Gina Martin MOT,b and Radhakrishnan Pillai PhDb| |
Recently, a new fixed combination product was introduced (clin 1.0%-BP 3.75% gel) that was shown to be effective in reducing both inflammatory and noninflammatory lesions in moderate to severe acne. Here, we assess the tolerability of clin 1.0%-BP 3.75% gel compared with adap 0.1%-BP 2.5% gel in healthy volunteers with no apparent facial redness or dryness over 21-days, using a split-face methodology.
Especially over the first two weeks of treatment, clin 1.0%-BP 3.75% gel was more tolerable than adap 0.1%-BP 2.5% gel, with statistically significant differences in cumulative change from baseline starting as early as day 8 (dryness) and day 9 (erythema), and composite index on days 8-12 and 16. Transepidermal water loss was less with clin 1.0%-BP 3.75% gel, although the difference was not statistically significant.
J Drugs Dermatol. 2016;15(2):178-182.
Efficacy of Topical Azelaic Acid (AzA) Gel 15% Plus Oral Doxycycline 40 mg Versus Metronidazole Gel 1% Plus Oral Doxycycline 40 mg in Mild-to-Moderate Papulopustular Rosacea
James Q. Del Rosso DO FAOCD, Suzanne Bruce MD, Michael Jarratt MD, Alan Menter MD, Gerald Staedtler| |
Adam S. Aldahan BS,a Stephanie Mlacker BS,a Vidhi V. Shah BA,a Lucy L. Chen MD,a Keyvan Nouri MD,a and James M. Grichnik MD PhDa,b| |
J Drugs Dermatol. 2016;15(6):713-714.
J Drugs Dermatol. 2012;11(7):879-880.
Comparison of Clindamycin/Benzoyl Peroxide, Tretinoin Plus Clindamycin, and the Combination of Clindamycin/Benzoyl Peroxide and Tretinoin Plus Clindamycin in the Treatment of Acne Vulgaris: A Randomized, Blinded Study
Steven Bowman MD, Michael Gold MD, Adnan Nasir MD PhD, George Vamvakias| |
Eric F. Bernstein MD| |
Study Design: A total of twenty subjects with chronic photodamage were enrolled in this study. Subjects received a maximum of four full-face treatments at an average fluence of 9.5 J/cm2 at 1,320 nm and 2 J/cm2 at 1,450 nm, delivered sequentially using forced-air cooling, at monthly intervals. Digital photographs were taken two months following the final treatment and compared to pre-treatment photographs by two blinded physician observers.
Results: Improvement in photodamage, overall appearance, wrinkles, hyper-pigmentation, enlarged pores, and sagging skin was rated by blinded physician evaluation of digital photographs as being in the 25-50 percent range. Subjective ratings averaged improved for all criteria that were evaluated, including wrinkles, enlarged pores, redness, sagging skin and hyper-pigmentation.
Conclusions: The multiplexed 1,320 nm and 1,440 nm fractionated laser improves cuta/neous photodamage as assessed by objective and subjective criteria.
J Drugs Dermatol. 2011;10(11):1266-1270.
Yamini V. Saripalli MD, Anthony A. Gaspari MD| |
Though TNF-α immunomodulation seems to be a very effective, promising treatment in several TNF-α mediated disease processes, long-term studies need to be performed to assess the risk-benefit ratio of using these drugs over an extended period of time.
Richard Fried MD PhD and Marge Nighland BS| |
In Vivo Determination of the Skin Atrophy Potential of the Super-High-Potency Topical Corticosteroid Fluocinonide 0.1% Cream Compared with Clobetasol Propionate 0.05% Cream and Foam and a Vehicle
Eugene H. Gans PhD, Iqbal Sadiq MS, Tracy Stoudemayer, Marianne Stoudemayer BS, Albert M. Kligman MD PhD| |
Michael H. Gold MD| |
The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments
Identifying the causes of alopecia and thinning hair has proven especially complex in women. Current treatment options include topical formulations, prescription medications, oral supplements, and costly hair transplants; but they all have drawbacks, such that a novel therapy is needed.
This supplement presents a summary of clinical studies that have demonstrated the welcome safety and efficacy of the nutraceutical Viviscal® (Lifes2good, Inc., Chicago, IL), which contains a proprietary blend of proteins, lipids, and glycosaminoglycans of marine origin that provide essential nutrients for stimulating existing hair growth and reducing hair shedding. The summary is followed by a lively panel discussion on hair loss and current therapies amongst experts in dermatology and plastic surgery: Vivian Bucay MD (San Antonio, TX), Wendy Roberts MD (Palm Springs, CA), Heidi Waldorf MD (New York, NY), and Steven Dayan MD (Chicago, IL).
Treatment of CO2 Laser Induced Hypopigmentation With Ablative Fractionated Laser Resurfacing: Case Report and Review of the Literature
Emily P. Tierney MD and C. William Hanke MD MPH| |
Whitney Bowe MD and Mary-Margaret Kober MD| |
Combined Effect of Anti-inflammatory Dose Doxycycline (40-mg Doxycycline, USP Monohydrate Controlled-Release Capsules) and Metronidazole Topical Gel 1% in the Treatment of Rosacea
Joseph F. Fowler Jr. MD| |
Laura McDermott BA,a Raman Madan MD,a Reena Rupani MD,b and Daniel Siegel MDa| |
METHODS: A PubMed search for the term “indigo naturalis” was performed, and literature from 2006 to the present relevant to indigo naturalis and treatment of psoriasis and nail psoriasis was reviewed.
RESULTS: Indigo naturalis shares several therapeutic mechanisms with current psoriasis treatments, such as regulation of keratinocyte proliferation and differentiation, restoration of epidermal barrier function, and reduction of inflammatory processes. Clinically, it is well tolerated.
CONCLUSION: Recent research of indigo naturalis suggests that it is a safe, inexpensive, and effective alternative topical treatment for skin and nail psoriasis.
J Drugs Dermatol. 2016;15(3):319-323.
The authors report a female patient with recalcitrant ulcerated necrobiosis lipoidica (NL) that was resistant to numerous systemic agents and who responded to treatment with intravenous immunoglobulin (IVIG), leading to resolution of the ulcerated areas for several months. Subsequent treatment with two further courses of IVIG was less effective, but a course of intravenous methylprednisolone led to regression of the lesions. As well as briefly reviewing the literature on treatments used to treat ulcerated NL, we outline the pathological mechanisms thought to be involved in the condition and how the modes of action of IVIG might explain its apparent efficacy in this case. As far as we are aware, the response of ulcerated NL to IVIG or methylprednisolone has not been reported previously, although other systemic preparations of corticosteroids have been used.
J Drugs Dermatol. 2012;11(2):256-259.
Assessment of the Mobile Delivery of InfraredLight (1100-1800 nm) for the Treatment of Facialand Neck Skin Laxity
Macrene Alexiades-Armenakas MD PhD| |
Objective: This prospective study assesses the safety, efficacy, and pain profile of the application of infrared light with a mobile delivery method for the treatment of facial and neck skin laxity as assessed by a tested, quantitative grading scale.
Methods: In this study, 22 female subjects (aged 40-75 years; Caucasian and Asian ancestry) with a clinically observable excess of laxity (minimum grade 2 out of 4) on the face received 1 to 3 treatments with incoherent infrared (1100-1800 nm) light at 2-week to 4-week intervals. Each light pulse was administered in a mobile continuous fashion within a localized area measuring approximately 1 handpiece tip-width laterally and vertically. A series of 4 to 5 pulses were administered across small grid areas, followed by 6 to 8 passes to each grid area, totaling approximately 300 to 450 pulses per treatment. Each mobile pulse was delivered at fluences of 45 to 46 J/cm2 to the face, 45 J/cm2 to the mandible, and 44 J/cm2 to the neck. Clinical results were evaluated employing a comprehensive 4-point grading scale from photographs at baseline, and the 1-month and 3-month follow-up visits after the final treatment. Pain ratings were evaluated by visual analog scale (VAS) gradings and patient questionnaire immediately following treatment.
Results: All subjects completed and responded to treatment. The mean treatment number was 2.1 (+/- 0.9) and the mean follow-up interval was 1.9 (+/- 1) months. The quantitative evaluations demonstrated: a mean baseline laxity grade of 2.9 +/- 0.5 and mean posttreatment laxity grade of 2.5 +/- 0.6; and a mean difference in prelaxity grades versus postlaxity grades of 0.4 +/- 0.3 (95% CI; 0.2540- 0.5415). The data demonstrated a statistically significant difference between before and after measurements (P<.0001) and a mean percent improvement in laxity grading scores of 14.1 +/- 11.3%. The treatment discomfort was rated as a mean of 0.7 (+/- 0.6) on a VAS grading scale (0 to 10). By patient questionnaire, sensation during the treatment was rated as painless by 100% of patients and rare (<5) transient moments of heat-related pain sensation were reported by 18% of patients. None of patients reported the procedure as painful or as sensing frequent (>5) or persistent heat-related pain sensation during the treatment. Other side effects included minimal erythema which resolved within 1 to 3 hours. No crusting, dyspigmentation, or scarring was observed.
Conclusion: This prospective clinical study with quantitative grading of laxity and VAS pain scores demonstrated that mobile delivery of infrared light appears to be safe, clinically effective, and painless in reducing facial and neck laxity. The mobile infrared light delivery allowed for delivery of approximately 30% higher fluence dosages and increased passes to each pulse area. The clinically observable and quantified decreases in skin laxity following treatment were statistically significant.
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s40-s43.
Predicting Improvement in Signs and Symptoms of Plaque Psoriasis After 1 Week of Treatment With Clobetasol Propionate 0.05% Spray
Steven R. Feldman MD PhD,a Warren Winkelman MD PhD,b Eric Baum MD,c Norman Preston PhDb| |
J Drugs Dermatol. 2013;12(12):1456-1460.
Cost-Effectiveness of a Fixed Combination of Hydroquinone/Tretinoin/Fluocinolone Cream Compared with Hydroquinone Alone in the Treatment of Melasma
Tania Cestari MD PhD, Lucie Adjadj, Margaret Hux MSc, Maria Regina Shimizu, Vincent Pierre Rives PharmD| |
Objective: To assess cost-effectiveness of triple combination therapy (TCT) applied once daily and hydroquinone alone applied twice daily in the US, Argentina, Brazil, Chile, and Colombia from a payer’s perspective.
Methods: Clinical data and utilazation of key health resources (medication only) were assessed within an 8-week- clinical trial conducted in Brazil. Total cost per primary success (complete clearing) was used to compare each treatment with not treating and incremental cost effectiveness ratios were used to compare between treatments.
Results and Conclusion: TCT has a 30% better rate of complete clearing than hydroquinone with a lower cost in the hydroquinone. Results were robust to varying assumptions of success rates ans quantity used.
Redaelli Alessio MD,a Berthold Rzany MD ScM,b Linda Eve MD,c Yann Grangier MD,d
Pedro Herranz MD,e Frédérique Olivier-Masveyraud MD,f and Danny Vleggaar MDg
J Drugs Dermatol. 2014;13(9):1057-1066.
Rodrigo Moraes Ferraz MD,a Ulrika Sandkvist MSc,b and Björn Lundgren PhDb| |
Sudeep J. Karve MS, Steven R. Feldman MD PhD, Brad A. Yentzer MD, Daniel J.Pearce MD, Rajesh Balkrishnan PhD| |
Scott A. Elman AB,a Joseph F. Merola MD MMSc,a,b April W. Armstrong MD MPH,c Kristina Callis Duffin MD,d John Latella,e Amit Garg MD,f Alice B. Gottlieb MD PhDg| |
The International Dermatology Outcome Measures (IDEOM) group, comprising patients, physicians, health economists, industry partners, payers, and regulatory agencies, was established to develop unified and validated patient-centered outcome measures in dermatology in response to increasing demand to quantify effectiveness of treatments and performance outcomes among providers. IDEOM has chosen to start with psoriasis outcome measures, and then apply its methodology to other dermatologic diseases. In this paper, we review the background and progress to date of IDEOM, including an update of IDEOM activities as of our 2016 meeting in Washington DC, USA. Briefly, the progress-to-date of a Delphi process to create outcome measures for psoriasis was reviewed, including preliminary data from the first round of Delphi voting. Updates were also heard from industry partners including the National Psoriasis Foundation (NPF) and the US Food and Drug Administration (FDA). Furthermore, plans to establish outcome measures for hidradenitis suppurativa (HS) were discussed.
J Drugs Dermatol. 2017;16(2):119-124.
R Balkrishnan PhD, A P Kelly MD, A McMichael MD, H Torok MD| |
Clinical Evaluation of the Safety and Efficacy of a Novel Superficial and Deep Carbon Dioxide Fractional System in the Treatment of Patients With Skin of Color
J Drugs Dermatol. 2012;11(11):1331-1335.
Andrew Blauvelt MD MBA,a April W. Armstrong MD MPH,b Gerald G. Krueger MDc| |
J Drugs Dermatol. 2015;14(8):805-812.
J Drugs Dermatol. 2012;11(11):1316-1230.
J Drugs Dermatol. 2012;11(10):1200-1206.
Jacob Dudelzak MD, Mussarrat Hussain MD,David J. Goldberg, MD JD| |
Objective: The efficacy and safety of a new 980-nm diode laser in the treatment of facial telangiectasias was evaluated.
Materials and Methods: Twelve subjects, aged 44 to 67 years with Fitzpatrick skin types 1 to 3 and bilateral facial telangiectasias, underwent 1 to 3 monthly treatments with a 980-nm diode laser using fluences ranging from 22.2 to 146.9 J/cm2, pulse durations of 50-160 ms, spot sizes of 0.7 to 1 mm, and pulse frequencies of 3 to 10 Hz. Clinical evaluation included digital photography, as well as subject and investigator assessment of reduction in the size and appearance of telangiectasias on a 1 to 5 point scale. Adverse effects were also assessed.
Results: Significant improvement in the appearance of telangiectasias was seen after treatment. No complications were observed.
Conclusion: A new 980-nm diode laser effectively treats facial telangiectasias without any observed complications.
Bilateral Comparison of the Efficacy and Tolerability of 3% Diclofenac Sodium Gel and 5% 5-Fluorouracil Cream in the Treatment of Actinic Keratoses of the Face and Scalp
Stacy R. Smith MD, Vera B. Morhenn MD, Daniel J. Piacquadio MD| |
Prospective, Multicenter Study to Determine the Safety and Efficacy of a Unique Radiofrequency Device for Moderate to Severe Hand Wrinkles
Janelle M. Vega MDa, Vivian W. Bucay MDb, and Flor A. Mayoral MDa| |
J Drugs Dermatol. 2013;12(1):24-26.
Patrick M. O’Shea BS and Aída Lugo-Somolinos MD| |
OBJECTIVE: To compare the efficacy and safety of methotrexate and acitretin in the treatment of chronic hand dermatitis.
METHODS: A chart-retrospective review of all patients with hand dermatitis seen by the primary author at the University of North Carolina Dermatology and Skin Cancer Center from September 2007 to April 2013.
RESULTS: Eighty-three hand dermatitis charts were reviewed. Twenty- nine patients received systemic therapy, of which 17 (26.5%) were treated systemically with acitretin and/or methotrexate. Of these 17 patients, four patients received courses of both acitretin and methotrexate independently after failing the alternative treatment course. At 6 months, acitretin achieved clearance/almost clearance in 44% of patients, compared to 0% of those treated with methotrexate. At 12 months, 100% of patients treated with acitretin achieved clearance/almost clearance compared to 40% of patients treated with methotrexate. Adverse effects were minimal and as expected.
LIMITATIONS: This was a retrospective study, and the small sample size makes it difficult to generalize results.
CONCLUSION: Systemic retinoids are a good alternative for the treatment of chronic hand dermatitis.
Ralph Fiore II DO, Sarah M. Coffman DO MSc, and Richard Miller DO| |
J Drugs Dermatol. 2013;12(3):353-357.
Ustekinumab Treatment for Psoriasis in 119 Patients Maintained on Therapy for a Minimum of One Year: A Review
Elizabeth G. Wilder MD,a Mahir Patel MD,a Katherine Hebeler BA,b and Alan Menter MDa| |
J Drugs Dermatol. 2014;13(8):905-910.
Janna M. Vassantachart MD,a Teo Soleymani MD,b and Jashin J. Wu MD FAADc| |
J Drugs Dermatol. 2016;15(8):995-1000.
Lauren K. Hoffman BSa and Leon Kircik MDb| |
J Drugs Dermatol. 2017;16(9):919-922.
Efficacy of Benzoyl Peroxide (5.3%) Emollient Foam and Benzoyl Peroxide (8%) Wash in Reducing Propionibacterium acnes on the Back
James J. Leyden MD| |
Objectives: To evaluate the effectiveness of BP (5.3%) emollient foam and BP (8%) wash in reducing P. acnes levels on the back.
Methods: Five-week open-label single-center study of 20 healthy subjects (>18 years old), colonized with P. acnes on their backs (>10,000 colonies per cm2). Subjects were treated once daily with BP (5.3%) foam for two weeks; no treatment in week 3, and BP (8%) wash once daily for two further weeks. Quantitative bacteriologic cultures obtained at baseline and weeks 1, 2, 3, 5 and 6. Results: Nineteen evaluable patients. Total P. acnes counts were reduced by 1.9 log (one week) and 2.1 log (two weeks) with BP (5.3%) emollient foam. BP (8%) wash did not reduce P. acnes counts after two weeks.
Discussion: BP (5.3%) emollient foam was superior to BP (8%) wash in reducing P. acnes on the back. The lack of effect of BP (8%) wash is surprising in view of the demonstrated results on the face and warrants further study.
Hilary C. Reich MD,a Irmina Wallander BA,b Lacie Schulte BA,b Hilary Frickman BA,b
and Suzanne Flickenger BA,b Brian Zelickson MDb
J Drugs Dermatol. 2015;14(4):391-399.
Lawrence F. Eichenfield MD,1 James Q. Del Rosso DO FAOCD,2 Anthony J. Mancini MD,3
Fran Cook-Bolden MD,4 Linda Stein Gold MD,5 Seemal Desai MD FAAD,6 Jonathan Weiss MD,7
David Pariser MD,8 Joshua Zeichner MD,9 Neal Bhatia MD,10 Leon Kircik MD11
J Drugs Dermatol. 2015;14(3):263-268.
Shivani S. Patel BS,a Karen E. Huang MS,a Alan B. Fleischer Jr. MD,a and Steven R. Feldman MD PhDa,b,c| |
METHODS: We conducted a query of ClinicalTrials.gov for dermatologic clinical trials from 2009 to 2013 for 6 common skin conditions: acne, psoriasis, rosacea, eczema and atopic dermatitis, actinic keratosis, and skin cancer. Results were sorted by condition and number of study subjects. This study did not involve any participants apart from the researchers.
RESULTS: Although there is an increasing trend in the number of trials performed annually, the results were not significant (P=.08). The average number of patients per study has not significantly changed (P=.12), but there was a significant increase in the number of large studies (201+ subjects) conducted over time (P=.002). Although there was significant variation based on dermatologic condition studied (global statistic P=.01), only skin cancer demonstrated a significant change in the number of studies registered annually (β=10.6 studies/year, P=.04).
CONCLUSIONS AND RELEVANCE: The sky does not appear to be falling, at least not yet, with regard to continued development of treatments for patients with skin disease.
J Drugs Dermatol. 2015;14(5):497-500.
Excimer Laser for Psoriasis: A Review of Theories Regarding Enhanced Efficacy Over Traditional UVB Phototherapy
Karine Zakarian MD, Alain Nguyen MD, Julie Letsinger MD, John Koo MD| |
Michael E. Farhangian BA,a Amy J. McMichael MD,a Karen E. Huang MS,a and Steven R. Feldman MD PhDa,b,c| |
OBJECTIVE: To better understand how AA was being treated in the United States, what type of patients are seen for AA, and what physicians treated them.
METHODS: We analyzed data from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) from 2001 to 2010. We tabulated patient characteristics, the physicians who treated AA and what treatments were prescribed for AA.
RESULTS: There were an estimated 2.6 million outpatient visits for AA. Patients with AA were most commonly treated by a dermatologists (84.8%). Patients were most commonly treated with topical and injected corticosteroids (61.0%) followed by minoxidil (5.9%) and topical tacrolimus (5.7%). Males made fewer visits per 1,000 capita compared to females (P=0.01).
LIMITATIONS: The NAMCS and NHAMCS do not record severity of disease data.
CONCLUSIONS: Topical and injected corticosteroids are the mainstay of treatment for AA, however the use of steroid sparing agents such as minoxidil is low. Despite no studies demonstrating efficacy, topical tacrolimus was used almost as frequently as minoxidil.
J Drugs Dermatol. 2015;14(9):1012-1014.
Treatment of Tattoos With a 755-nm Q-switched Alexandrite Laser and Novel 1064 nm and 532 nm Nd:YAG Laser Handpieces Pumpedby the Alexandrite Treatment Beam
Eric F. Bernstein MD MSE, Jay Bhawalkar PhD, Joan Clifford MPH, James Hsia PhD| |
Treatment of Inverse/Intertriginous Psoriasis: Updated Guidelines from the Medical Board of the National Psoriasis Foundation
Hasan Khosravi MD,a Michael P. Siegel PhD,b Abby S. Van Voorhees MD,c and Joseph F. Merola MD MMSca,d| |
Inverse or intertriginous psoriasis commonly involves skin fold areas including the axillae, perianal skin, intergluteal cleft, inframammary, genital/inguinal, abdominal, and retroauricular folds. After reviewing the literature for new treatments, a task force was convened to update a consensus on inverse psoriasis therapy. Short-term treatment continues to be low-potency topical steroids. In order to avoid steroid-induced adverse effects, long-term therapy includes topical immunomodulators, calcitriol, and calcipotriene. Second and third-line therapies include antimicrobials, emollients, and tar-based products. Inverse psoriasis resistant to topical therapy has been shown to respond to botulinum toxin injections, excimer laser therapy, and certain systemic agents (such as anti-TNF and anti-IL12/IL23 therapy). Based on promising results from case reports and prior clinical experience, these systemic agents should be strongly considered in inverse psoriasis resistant to topical therapy. However, they need further evidence-based evaluation. The use of randomized trials and objective severity indices may allow for more robust therapeutic data.
J Drugs Dermatol. 2017;16(8):760-766.
Safe and Efficacious Use of Intralesional Steroids for the Treatment of Focally Resistant Mycosis Fungoides
Deede Y. Liu MD,a* Tarek Shaath BA,b* Anand N. Rajpara MD,a Cody Hanson BS,c
Garth Fraga MD,d Ryan Fischer MD,a and Daniel J. Aires MDa
J Drugs Dermatol. 2015;14(5):466-470.
Clinical Improvement and Safety of Ablative Fractional Laser Therapy for Post-Surgical Scars: A Systematic Review of Randomized Controlled Trials
Trenton Custis MDa,b and Daniel B. Eisen MDa| |
OBJECTIVE: To identify randomized trials that study the efficacy of ablative fractionated laser therapy for treatment of surgical scars.
METHODS AND MATERIALS: EMBASE, Web of Science, and Pubmed databases were searched for randomized trials with 10 or more surgical wounds. No restrictions were placed on the language of the publications.
RESULTS: Three randomized trials were identified that met the criteria for the review. One study found superior efficacy of ablative fractionated laser treatment of surgical scars compared to pulsed dye laser while the others found equivalent efficacy when compared to dermabrasion or pulsed dye laser. One study found a superior safety profile for ablative fractionated laser treatment over dermabrasion. No studies compared fractionated laser therapy to sham therapy or observation.
CONCLUSIONS: AFL compares well with the scar amelioration techniques of dermabrasion and pulsed dye laser. Additional studies are needed to further contrast AFL to these and other modalities as well as to observation alone.
J Drugs Dermatol. 2015;14(11):1200-1204.
Lindsey Warino MS, Rajesh Balkrishnan PhD, Steven R. Feldman MD PhD| |
Intense Pulsed Light versus Advanced Fluorescent Technology Pulsed Light for Photodamaged Skin: A Split-Face Pilot Comparison
Martin Braun MD| |
Rungsima Wanitphakdeedecha MD MA MSc,Elizabeth L. Tanzi MD, Tina S. Alster MD| |
Background: A wide variety of laser and light-based therapies have been utilized for acne vulgaris; however, current techniques have been limited by photosensitivity issues or inconsistent results.
Objective: To determine the clinical efficacy and side-effect profile of photopneumatic therapy for the treatment of facial acne vulgaris.
Methods: Twenty adults with mild to severe facial acne vulgaris received 4 successive treatments at 2-week intervals with a combined photopneumatic device (intense pulsed light [IPL]: fluences=3.6-4.2 J/cm2; negative pressure=3 psi). Clinical improvement was evaluated on a quartile grading scale using comparative digital photographs at baseline, and 1 month and 3 months after the final treatment. Acne lesion counts were obtained at baseline, prior to each treatment session, and at the end of the study.
Results: Modest reduction in acne lesion counts and global clinical improvement was seen in the majority of patients. Patients with severe acne experienced the most clinical improvement. Side effects were mild and limited to transient erythema and rare purpura. Most patients experienced acne worsening early in the treatment course.
Conclusion: Photopneumatic therapy is a safe and effective treatment for acne vulgaris. Patients with more severe acne respond best to treatment.
Avnee Shah BS, Jenna ONeill MD, Steven R. Feldman MD PhD| |
The Effect of Lidocaine When Mixed with Large Gel Particle HyaluronicAcid Filler on Tolerability and Longevity: A Six-month Trial
Mary P. Lupo MD FAAD, Glenda Swetman MD, William Waller MD| |
Treatment of Psoriasis and Long-term Maintenance Using 308 nm Excimer Laser, Clobetasol Spray, and Calcitriol Ointment: A Case Series
J Drugs Dermatol. 2012;11(8):994-996.
Michael H. Gold MD, Julie Biron BS| |
Objective: The objective of this study was to evaluate the safety and efficacy of photopneumatic technology for the treatment of mild to moderate acne vulgaris.
Methods: Eleven subjects (7 women) aged 15 to 54 years with skin types 1 to 4 presented with mild to moderate facial acne (defined as 15 or more facial inflammatory or noninflammatory lesions) were recruited to the study. All subjects underwent 4 photopneumatic treatments at 3-week intervals with follow-up visits at 1 and 3 months.
Results: Inflammatory lesion counts continued to decrease for at least 3 months after the final treatment. At 3 months, reductions in lesion counts were significant for both inflammatory (P=.0137) and noninflammatory (P=.0383) lesions. Mean scores between visits consistently dropped sharply from their immediate posttreatment values for pain, erythema, and edema. Nine subjects (82%) were moderately satisfied to very satisfied with treatment.
Conclusion: Results suggest that the photopneumatic device is a safe and effective modality for the treatment of mild to moderate inflammatory and comedonal acne vulgaris.
Salicylic Acid 6% in an Ammonium Lactate Emollient Foam Vehicle in the Treatment of Mild-to-Moderate Scalp Psoriasis
Leon Kircik MD| |
J Drugs Dermatol. 2011;10(3):270-273.
Aditya K. Gupta MD PhD FRCPC,a Boni E. Elewski MD,b Ted Rosen MD,c Bryan Caldwell DPM,dd David M Pariser MD,e Leon H. Kircik MD,f Neal Bhatia MD,g and Antonella Tosti MDh| |
J Drugs Dermatol. 2016;15(3):279-282.
The Biological Rationale for Use of Vitamin D Analogs in Combination With Corticosteroids for the Topical Treatment of Plaque Psoriasis
Siegfried Segaert MD PhDa and Mads Røpke PhDb| |
J Drugs Dermatol. 2013;12(8):e129-e137.
Vasanop Vachiramon MD,a,b Trudy Brown LEI CLS CPE,a,c Amy J. McMichael MDa| |
Objectives: To determine patient satisfaction and complications with long-pulsed Nd:YAG laser assisted hair removal in dark-complexioned skin individuals from the patient's point of view.
Patients/Methods: A survey questionnaire was administered to subjects with Fitzpatrick skin type VI between the ages of 21-70 years who had been treated with long-pulsed Nd:YAG for unwanted hair. Questions were comprised of those related to satisfaction and complications from treatment with LHR. Satisfaction was recorded on a linear analogue scale (LAS=not at all satisfied; 100=extremely satisfied).
Results: Fifty patients (female 41, male 9) completed the survey. All patients were satisfied with Nd:YAG LHR treatment with the mean satisfaction score of 84.2. All patients favor LHR treatment as compared to alternative methods. The majority of patients (79.3%) who had completed six or more LHR treatments were removing their hair less frequently than before LHR treatment. Hyperpigmentation after treatment was noted in three patients (6%), which lasted for 3-10 days. No hypopigmentation, blistering, or scarring was observed. All patients completing the study would recommend LHR for patients with unwanted hair with the mean recommendation score of 91.5.
Conclusions: Nd:YAG laser-assisted hair removal gives a high rate of patient satisfaction in terms of hair reduction with minimal complication among subjects of color.
J Drugs Dermatol. 2012;11(2):191-195.
Successful Treatment of Traumatic Onychodystrophy and Associated Pterygium Unguis With Fractionated Carbon Dioxide Laser: Case Report and Review of the Literature
Derek Ho BS,a,b Andrew Mamalis MD MS,a,b and Jared Jagdeo MD MSa,b,c| |
Randomized, Controlled, Evaluator-Blinded Studies Conducted to Compare the Efficacy and Tolerability of 3 Over-the-Counter Acne Regimens in Subjects With Mild or Moderate Acne
Lawrence Green MD,a Leon H. Kircik MD,b-d and Jennifer Gwazdauskas MBAe| |
Objectives: To compare the efficacy, user satisfaction, and tolerability of the OTC regimens MaxClarity™, Proactiv®, and Murad® in the treatment of mild and moderate acne. Methods: Two randomized, evaluator-blinded, split-face studies were conducted, each involving 20 subjects with acne, to evaluate MaxClarity against Proactiv (study 401) and MaxClarity against Murad (study 404) over 8 weeks.
Results: Clinically and statistically significant reductions in acne lesion counts were achieved at 8 weeks compared with baseline for each regimen using MaxClarity, Proactiv, and Murad. Similar reductions in lesion counts and improvements in Investigator's Static Global Assessment grades were observed between MaxClarity and either Proactiv or Murad, in the respective studies. MaxClarity was well tolerated, with no treatment-related adverse events observed in any treatment group and no discontinuations due to adverse events. Overall, most subjects were satisfied with all study treatments.
Conclusions: MaxClarity is an effective alternative to either Proactiv or Murad for use in the treatment of mild and moderate acne.
J Drugs Dermatol. 2013;12(2):180-185.
Wm. Philip Werschler MD FAAD FAACS,a Julius W. Few Jr. MD,b Carolyn I. Jacob MD FAAD,c
John H. Joseph MD,d James M. Spencer MD MS,e and Amy Forman Taub MDf
J Drugs Dermatol. 2016;15(5):518-525.
Hilary E. Baldwin MD FAAD,a Ariane K. Kawata PhD,b Selena R. Daniels PharmD MS,c
Teresa K. Wilcox PhD,b Caroline T. Burk PharmD MS,d Emil A. Tanghetti MDe
OBJECTIVE: The purpose of this analysis was to evaluate health care resource utilization (HRU) and treatment patterns in cohorts with and without the use of acne medication and predictors of use.
METHODS: A cross-sectional, web-based survey was administered to US females (25–45 years) with facial acne (≥25 visible lesions). Data collected included: sociodemographics and self-reported clinical characteristics, acne treatments, and health care professional (HCP) visits. Subject characteristics associated with medication use were examined by logistic regression.
RESULTS: Approximately half of the total sample (N=208, mean age: 35±6) ever visited an HCP for acne and reported more over-the counter (OTC) medication use (51.0%) than prescription (Rx) medication use (15.4%). Subjects did not use medications daily, averaging from 12–18 days over the previous 4 weeks. Logistic regression showed that race and prior HCP visits for acne were significant predictors of medication use (P<.05).
CONCLUSIONS: Adult females generally self-treated their acne using primarily OTC medications; however, poor compliance was observed for Rx and OTC. Race and prior HCP visits for acne were significant predictors of current medication use.
J Drugs Dermatol. 2015;14(2):140-148.
Use of a Collagen-glycosaminoglycan Copolymer (Integra) in Combination WithAdjuvant Treatments for Reconstruction of Severe Chest Keloids
Steven P. Davison MD DDS, Joseph F. Sobanko MD, Mark W. Clemens MD| |
Methods: The authors’ group has followed five patients with chronic chest keloids refractory to myriad of interventions and treated these patients with surgical excision followed by Integra placement into the wound bed on the chest. Split-thickness grafts were applied shortly thereafter. Patients were followed at regular intervals and all patients received adjuvant therapy with single-dose radiation and intralesional chemotherapy (triamcinolone and/or 5 fluorouracil).
Results: This treatment protocol has provided a cure rate of 100% over an average of 43 months follow-up. The symptoms often accompanied by these chest keloids also appear to improve.
Conclusion: The authors believe that this study provides the groundwork for further investigation of Integra for surgical management of keloids. A placebo-controlled study should be performed to adequately determine if this data holds true.
Megasessions: Efficacy of Fewer, Longer Treatment Sessions for Fat Reduction in Noninvasive Body Contouring Using a Radiofrequency Based Device
Diane Duncan MD FACS| |
While the field of noninvasive body contouring is booming, many patients still note a lesser result than they might achieve with a single session of liposuction or dermolipectomy. The duration of a noninvasive fat reduction treatment series can be daunting. Patients have questioned the worth of these procedures when the expected benefit is modest and the time they devote to the project is significant. An eight-patient mini-study was performed to see if two or three “megasessions” could be substituted for eight weekly sessions of bipolar radiofrequency based fat reduction treatments. Patients were randomized into a two session or three session group by drawing straws. The device used was the BodyFX bipolar RF device by InMode. This device employs a suction coupled vacuum that heats a section of skin and soft tissue in the treatment region and delivers a high voltage pulse. Each patient was treated for 2 hours per session, using the Body FX, more superficial Mini FX, and the Deep FX device in an effort to treat on a multilevel basis. Preoperative 2D and 3D Vectra photos were taken, and were repeated at 1 month and 3 months post-treatment. Volumetric analysis and patient assessment showed similar results with a two or three treatment “megasession” protocol when compared with the traditional protocol of eight weekly sessions. While the cohort number was not statistically significant, the photographs and measurements are compelling enough to warrant further investigation into this treatment protocol.
J Drugs Dermatol. 2017;16(5):478-480.
Jerry Tan MD,a/sup> Sewon Kang MD,b/sup> and James Leyden MDc| |
J Drugs Dermatol. 2017;16(2):97-102.
The Efficacy, Safety, and Tolerability of Adapalene Versus Benzoyl Peroxide in the Treatment of Mild Acne Vulgaris: A Randomized Trial
S.H. Babaeinejad MD and R.F. Fouladi MD| |
J Drugs Dermatol. 2013;12(7):790-794.
Adrenergic Urticaria and Rheumatoid Arthritis in a Patient With Melanoma: An Intricate Medical Management
Adrenergic urticaria is an uncommon yet probably under-diagnosed form of urticaria,¹ which is considered a form of neurogenic acute reaction mainly triggered by acute stress.²,³ The author presents a case of AU, however, that is only partially explained by a stress setting, though it is strongly associated with the course of an autoimmune disease.
J Drugs Dermatol. 2012;11(3):409-412.
12-month Effects of Stabilized Hyaluronic Acid Gel Compared With Saline for Rejuvenation of Aging Hands
Elena I. Gubanova MD,a,b Polina A. Starovatova MD,a,b Maria Y. Rodina MDc| |
Thirty women (mean age: 53 years) provided data up to M05. At M03, HA gel treatment improved hand skin condition in all patients versus D01, according to the GAIS; improvements were sustained to M12. Mean patient scores at M01–M03 were significantly higher for HA gel than for saline (P<0.05). Self-assessment questionnaire grades up to M03 were generally significantly better for HA gel versus saline (P<0.05); grades were maintained to M12. Statistically significant improvements with HA gel in hydration and elasticity was demonstrated at M03, compared with D01 and saline (P<0.05), and in terms of skin roughness versus D01. Maximum roughness (P<0.05) and waviness (P<0.01) were significantly improved versus saline.
All AEs were mild and anticipated, with no serious AEs.
Overall, HA gel injections were generally well tolerated and efficacious for rejuvenation of aging hands compared with saline. Sustained improvements at 12 months compared with baseline indicate that efficacy could be maintained long term.
J Drugs Dermatol. 2015;14(3):288-295.
Gary Grove PhD,a Charles Zerweck PhD,a and Jennifer Gwazdauskas MBAb| |
J Drugs Dermatol. 2013;12(6):644-649.
Alexis Lyons MD MS,a Jillian Roy RN,a Jennifer Herrmann MD FAAD,a,b,c Lisa Chipps MD FAAD,a,c| |
J Drugs Dermatol. 2018;17(1):74-76.
Bilateral Axilla Hair Removal Comparing a Single Wavelength Alexandrite Laser With Combined Multiplexed Alexandrite and Nd:YAG Laser Treatment From a Single Laser Platform
Methods: Subjects received four laser treatments at 4-6 week intervals. One axilla was treated with the alexandrite laser alone while the contralateral axilla was treated with multiplexed pulses delivering either a 755 nm/1064 nm pulse or a 1064 nm/755 nm pulse. Efficacy was evaluated through blinded hair counts performed on digital photographs taken two and six months following the final treatment.
Results: Mean hair clearance percentages were 83%, 81%, and 86% for the alexandrite, alexandrite/YAG sequence, and YAG/alexandrite sequence, respectively. Side effects were minimal and did not differ by treatment.
Conclusion: Muliplexed 755 nm/1064 nm and 1,064 nm/755 nm pulses compared favorably with the 755 nm pulses for efficacy and side-effect profile, all being highly efficacious. Further study of the multiplexed pulses in various clinical settings, including refractory hair removal, are indicated.
J Drugs Dermatol. 2012;11(2):185-190.
Eric F. Bernstein MD MSE,a Jay Bhawalkar PhD,b Joan Clifford MS,b James White,b James Hsia PhDb| |
Background: Due to the hemoglobin-selective wavelength of the 595 nm pulsed-dye laser, it is a device of choice for treating cutaneous
vascular lesions. However, it is less effective and removing dyschromia, which along with hypervascularity is a cardinal sign of cutaneous
photodamage. A novel 607 nm dye laser was developed as a first step in creating a dual-wavelength pulsed-dye laser.
Study Design/Materials and Methods: Twenty-five subjects with dyschromia on the chest due to chronic photodamage were enrolled into an open-label study to explore the safety and efficacy of a 607 nm pulsed-dye laser, with 22 completing the study. Two treatments were administered to the chest, one month apart, with fluences ranging from 3-6 J/cm,2 using a 10 mm diameter spot and pulse duration of 1.5 msec. Cross-polarized digital photographs were taken before and two months following the final treatment and rated for improvement by physicians in a blinded fashion.
Results: Improvement was rated on a five-point scale with no subjects rated as poor (<25%) clearance, three subjects (13.6%) demonstrating fair (26-50%) improvement, seven subjects (31.8%) rated as good (51-75%) improvement, 12 (54.5%) were rated as excellent (76-95%) improvement, while none were rated as outstanding improvement (>95%).
Conclusion: This is the first study of the 607 nm pulsed-dye laser which showed it to be safe and effective for treating dyschromia of the chest due to chronic photodamage, and may in the future expand the ability of the pulsed-dye laser to treat photodamaged skin.
J Drugs Dermatol. 2011;10(4):388-394.
The Efficacy, Safety and Tolerability of Adapalene Versus Benzoyl Peroxide in the Treatment of Mild Acne Vulgaris; A Randomized Trial
S.H. Babaeinejad MD and R.F. Fouladi MD| |
J Drugs Dermatol. 2013;12(9):1033-1038.
Ablative Fractionated CO2 Laser Resurfacing for the Neck: Prospective Study andReview of the Literature
Emily P. Tierney MD and C. William Hanke MD MPH| |
Design: A prospective pilot study for neck resurfacing in 10 subjects with a series of one-to-three treatment sessions. Treatment sessions were administered at six-to-eight week intervals with blinded physician photographic analysis of improvement at two months post-treatment. Blinded physician photographic evaluation was performed of four clinical indicators, skin texture, skin laxity, rhytides and overall cosmetic outcome.
Results: The number of treatments required for improvement of neck texture and laxity ranged from 1–3, with an average of 1.4. For skin texture, the mean score improved 62.9% (95% CI: 57.4%, 68.4%), skin laxity, 57.0% (53.2%, 60.8%), and rhytides, 51.4% (48.3%, 54.5%). For overall cosmetic outcome, the mean score improved 59.3% (55.1%, 63.5%) at two months post treatment.
Conclusion: In this prospective study, AFP was both safe and effective for the treatment of neck laxity, rhytids and skin texture. The degree of improvement observed in wrinkling, texture and laxity after AFP coupled with the benign side effect profile has not been reported with previous trials of ablative laser resurfacing of the neck.
Evaluating the Tolerability and Efficacy ofEtanercept Compared to TriamcinoloneAcetonide for the Intralesional Treatment ofKeloids
Bruce Berman MD PhD, Jitendrakumar K. Patel MD,Oliver A. Perez MD, Martha H. Viera MD, Sadegh Amini MD,Samantha Block, Deborah Zell MD, Sujatha Tadicherla MD,Adriana Villa MD, Claudia Ramirez MD, Tami De Araujo MD| |
Background: Tumor necrosis factor-alpha (TNF-α) is a proinfl ammatory and profi brotic cytokine that inhibits degradation of collagen and glycosaminoglycans. Etanercept, a recombinant TNF-α receptor fusion protein, may decrease excessive fi brous tissue in keloids.
Objective: To evaluate the tolerability and effi cacy of etanercept as compared to triamcinolone acetonide (TAC) for the treatment of keloids.
Methods: Twenty subjects were randomly assigned to receive monthly intralesional injections of either 25 mg of etanercept or 20 mg of TAC for 2 months. Keloids were evaluated at baseline, week 4, and week 8 by subjects and investigators in a blinded fashion using physical, clinical, and cosmetic parameters. Photographs were taken and adverse events were noted during each evaluation.
Results: Etanercept improved 5/12 parameters including signifi cant pruritus reduction, while TAC improved 11/12 parameters at week 8, although no statistical difference was observed as compared to baseline. There was no signifi cant difference between the 2 treatment groups. Both treatments were safe and well tolerated.
Conclusion: Etanercept was safe, well tolerated, improved several keloid parameters, and reduced pruritus to a greater degree than TAC therapy. However, further studies are required before it can be recommended for the treatment of keloids.
Ricardo Ruiz-Rodriguez MD PhD, Laura Lopez MD, Daniel Candelas MD, Javier Pedraz MD| |
Objective: To evaluate clinical efficacy and side effects of photodynamic therapy using topical 5-methyl aminolevulinate and red light for photorejuvenation.
Methods: A randomized, prospective, split-face comparison study of 10 white, adult patients with moderate photodamage, Fitzpatrick skin types 2 or 3, and no occurrence of actinic keratosis was performed. Three treatments using topical methyl aminolevulinate cream, applied for 1 hour on one half of the face and 3 hours on the other half before illumination with red light. A blinded investigator prior to treatment and 2 months after the third treatment evaluated each side of the subject’s faces.
Results: A moderate improvement in fine lines, tactile roughness, and skin tightness was observed in most of the patients, mostly on the 3-hour time side. There were no changes in mottled pigmentation or telangiectasias. Side effects were observed in all subjects (erythema, edema, scaling) mainly in the 3-hour incubation time side.
Limitations: The small number of patients and the lack of placebo group. Conclusion: Methyl aminolevulinic-photodynamic therapy with red light can improve fine lines, tactile roughness and skin tightness in patients with moderate photoaging and no occurrence of actinic keratosis.
Habib Ansarin MD, Sayied Savabynasab MD,Ashkan Heshmatzade Behzadi MD, Nader Sadigh MD,Jaleh Hasanloo MD| |
Objective: The goal of this study was to determine the efficacy of levamisole in addition to doxycycline in the treatment of patients suffering from severe nodulocystic acne.
Methods: A double-blind, randomized, placebo-controlled trial was conducted in the dermatology clinic of Rasoul-e-Akram Hospital in Tehran, Iran in 2006. Sixty patients were randomly assigned to 1 of 2 study groups. The case group was administered oral levamisole 2.5 mg/kg/wk (up to 150 mg/wk) plus doxycycline 100 mg daily and the control group was given 100 mg of oral doxycycline daily and a placebo. Patients were evaluated at baseline, and at 2-month, 4-month, and 6-month checkpoints.
Results: The responses to treatment were significantly higher in the case group according to the reduction in total lesions count, acne severity index; and papule/pustule and nodule/cyst count at the 2nd, 3rd, and 4th visits.
Conclusion: Results indicated that adding oral levamisole to doxycycline is an effective treatment for severe nonresponsiveness to conventional treatments of acne vulgaris. In the patient group, levamisole was well tolerated with an acceptable safety profile. At the time of publication, this study is the first clinical trial that suggests levamisole as an effective new treatment for severe acne vulgaris.
2017 ODAC CONFERENCE ARTE POSTER WINNER: Bioinformatics Analysis of the Inflammatory Acne Transcriptome Supports Mechanisms of Action for Current Treatments and Predicts Novel Therapies In Vivo
Rivka C. Stone MD PhD and Marjana Tomic-Canic PhD| |
J Drugs Dermatol. 2017;16(11):1166-1169.
J Drugs Dermatol. 2012;11(7):804-807.
Qiuhong Yang MS,a* Daniel J. Aires MD JD,b* Shuang Cai PhD,a Garth R. Fraga MD,b
Da Zhang MD,b Cicy Z. Li MS,b and M. Laird Forrest PhDa
METHODS: Human melanoma cell line A-2058 tumor cells were injected into athymic mice. After tumors grew to 50~100 mm3 mice were divided into five groups: (1) nontreated (2) intravenous (i.v.) cisplatin, (3) i.v. nano hyaluronan-conjugated cisplatin (HA-Pt), (4) subcutaneous (s.c.) peri-tumoral cisplatin, and (5) s.c. peri-tumoral HA-Pt. All treatment groups received 3 weekly doses of 10 mg/kg.
RESULTS: Tumors grew progressively in all control, i.v. cisplatin, and s.c. cisplatin groups. Tumors showed a trend toward slower growth in the i.v. HA-Pt group, but all animals died or were euthanized per protocol within 3 weeks of treatment. Tumors showed shrinkage only in the subcutaneous peri-tumoral HA-cisplatin group; one of these mice appeared to be cured.
CONCLUSIONS: Peri-tumoral HA-cisplatin may be shown potential as a therapeutic option in treatment of certain types of melanoma.
J Drugs Dermatol. 2014;13(3):283-287.
Trends in the Treatment of Acne Vulgaris: Are Measures Being Taken to Avoid Antimicrobial Resistance?
Megan A. Kinney MHAM BS,a Brad A. Yentzer MD,a Alan B. Fleischer Jr. MD,a Steven R. Feldman MD PhDa,b,c| |
Purpose: The aim of this study was to assess trends in prescribing antibiotics for acne from 1997−2006.
Methods: The authors examined the National Ambulatory Medical Care Survey (NAMCS) database and recorded medications at all visits to the physician in which acne vulgaris (ICD-9-CM code 706.1) was the only diagnosis from 1997−2006.
Results: Declines in the use of erythromycin and isotretinoin (both P<0.001) for acne were noted for all physicians. Tetracyclines saw significant increases in use by both dermatologists and non-dermatologists (P<0.01 and P=0.05, respectively). Prescribing of benzoyl peroxide monotherapy was unchanged for non-dermatologists (P=0.22) and is on the decline for dermatologists (P<0.001). The use of BPO + clindamycin combination topical treatments rose sharply for all physicians (P<0.001), resulting in greater use of both total BPO and total clindamycin for acne over time (P<0.001). Topical retinoid use increased among dermatologists (P<0.05) but appeared to be on the decline among non-dermatologists (P=0.067).
Conclusion: The development of antibiotic resistance is of concern. Greater awareness of retinoid use for maintenance therapy, using topical benzoyl peroxide to prevent resistance, and limiting use of oral antibiotics to as short a time period as possible are measures to contribute to better eco-responsible acne treatment.
Histological and Clinical Studies on the Effects of Low to Medium Level Infrared Light Therapy on Humanand Mouse Skin
Koichiro Kameyama MD PhD| |
Study Design/Materials and Methods: Ten, 20, or 30 J/cm2 infrared light were irradiated on the human subject’s skin (thigh), while 5, 10, 20, or 30 J/cm2 were used on amelanotic mouse skin. Biopsies were taken and analyzed using hematoxylin and eosin (H&E) and Elastica von Gieson stain.
Results: Ten or 20 J/cm2 infrared light increased the amount of both collagen and elastin in all layers of the dermis without denaturing the collagen in human skin. A higher dose of 30 J/cm2 also increased the amount of collagen and elastin, but denatured the collagen in human skin. (In addition to the thigh, 2 treatments of 10 J/cm2 infrared light improved skin toning and texture on the subject’s face.) In mouse skin, 5 or 10 J/cm2 remarkably increased the amount of both collagen and elastin, and of epidermal cells. Twenty or 30 J/cm2 increased the amount of collagen and elastin and the number of keratinocytes, but caused some vacuolated degeneration of keratinocytes. The presence of denatured collagen was not evident due to the high density of collagen.
Conclusions: This study shows that the denaturation of collagen is not required to increase the amounts of collagen or elastin in vivo in human skin. The activation of the mitochondria as well as the denaturation of collagen may play important roles in infrared phototherapy.
Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study
Ulrike Blume-Peytavi MD,a Jerry Shapiro MD,b Andrew G. Messenger MD,c Maria K. Hordinsky MD,d Paul Zhang PhD,e Carlos Quiza MD,e Uday Doshi PhD,e and Elise A. Olsen MDf| |
OBJECTIVE: Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks. METHODS: In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage.
RESULTS: Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm2 at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm2 at week 24. The treatment difference was –0.3 hairs/cm2 (95% CI = –6.0, 5.4). Since the lower bound of the 95% CI was less than –5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated.
CONCLUSIONS: Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met.
ClinicalTrials.gov identifier: NCT01145625
J Drugs Dermatol. 2016;15(7):883-889.
Novel Nonablative Radio-Frequency Rejuvenation Device Applied to the Neck and Jowls: Clinical Evaluation and 3-Dimensional Image Analysis
Lisa K. Chipps MD MS,a,b,c Jason Bentow MD,c Heidi B. Prather MD,d Jeffrey J. So MS PA-C,a
Jonathan M. Schouest BS,a and David M. Ozog MD,a,e Ronald L. Moy MDa,b
STUDY DESIGN: Forty-nine subjects received a total of two radio-frequency treatments to the face and neck one-month apart. The novel radio-frequency delivery device was used to heat the dermis between 41-43°C for five heat cycles. Primary outcome measures were clinical efficacy quantified by the Global Assessment Improvement Scale (GAIS) and a patient survey that assessed treatment satisfaction.
RESULTS: Assessments of 3D photographs revealed an overall improvement in 74% of study subjects. 85% of patients noted an overall improvement in the appearance of their skin. 81% of patients rated their post-treatment skin laxity as improved, 85% rated their skin smoothness as improved and 62% rated their skin brightness as improved.
CONCLUSION: Subjects in this study demonstrated an overall improvement in face and neck appearance with regard to skin tightening, wrinkles, and skin texture suggested by overall patient satisfaction (85%) and physician-rated GAIS improvement (74%). This study suggests that radiofrequency applied with a continuous thermal treatment device is a safe and efficacious way to improve the overall appearance of aging facial skin.
J Drugs Dermatol. 2013;12(11):1215-1218.
Ann G. Martin. MD| |
Cosmetic Use of AbobotulinumtoxinA in Men: Considerations Regarding Anatomical Differences and Product Characteristics
Jason D. Bloom MD,a Jeremy B. Green MD FAAD,b Whitney Bowe MD,c Erika von Grote PhD,d and Alessandra Nogueira MDd| |
Among the product options available in the US, Dysport® (abobotulinumtoxinA) (Galderma Laboratories, L.P., Fort Worth, Texas) is unique in that its recommendations for reconstitution provide the clinician with 2 different final product concentrations. The flexibility provided by a variable dose may be a valuable tool for tailoring treatments to male patient-specific needs, which may include a more conservative outcome, maintaining a certain degree of muscle activity and expressivity. Achieving a conservative outcome may be the key to a positive experience for the male patient.
J Drugs Dermatol. 2016;15(9):1056-1062.
Treatment of Hidradenitis Suppurativa by Photodynamic Therapy With Aminolevulinic Acid: Preliminary Results
Eric S. Schweiger MD,a Christy C. Riddle MD,b Daniel J. Aires MDb| |
Background: The current standard of care for hidradenitis suppurativa (HS) includes antibiotics (oral/topical), retinoids (oral/topical)
and intralesional steroids and is unsatisfactory. Photodynamic therapy (PDT) with 20% 5-aminolevulinic acid (ALA) has been used
"off label" to treat acne vulgaris and may hold promise as a therapy for HS. This open-label, non-blinded study investigated the efficacy
and safety of ALA PDT for the treatment of HS using two blue light sources and intense pulsed light (IPL) for photoactivation.
Methods: Twelve subjects with active HS enrolled to undergo ALA PDT once weekly for four weeks with follow-up visits 4, 8, and 12 or more weeks later. Nine subjects completed the study through the week 8 follow-up visit. Lesions were counted at each treatment visit at week 4, week 8 and at the final week.
Results: Mean lesion counts were 11.25 at baseline, 6.5 at 4 weeks (50.8% reduction), and 7.5 at 8 weeks (29.9% reduction). Mean Global Severity Scores were 2.2 at baseline, 1.5 at 4 weeks, and 1.8 at 8 weeks. Mean DLQI scores were 17.3 at baseline, 13.1 at 4 weeks (27.2% improvement), 14.00 at 8 weeks (19.3% improvement) and 14.0 (19.3% improvement) at the final week (16-62 weeks). Three subjects (25%) had complete clearance and no active lesions 4 weeks after the final treatment. Treatments were more tolerable for subjects treated with blue light than with IPL.
Conclusion: ALA PDT may be a safe and effective treatment of hidradenitis suppurativa.
J Drugs Dermatol. 2011;10(4):381-386.
Efficacy and Tolerability of a Cosmetic Skin Care Product With Trans-4-t-butylcyclohexanol and Licochalcone A in Subjects With Sensitive Skin Prone to Redness and Rosacea
Zorica Jovanovic PhD,a Nariman Angabini MD,b Sonja Ehlen MD,c Zrinka Bukvic Mokos MD,d Milica Subotic MD,e and Gitta Neufang PhDa| |
BACKGROUND: Sensitive skin and rosacea are skin conditions, which may affect the quality of life of the patients considerably. In vitro and in vivo data indicated that the combination of trans-t-butylcyclohexanol and licochalcone A is an effective combination for alleviating the increased sensitivity of rosacea subtype I.
OBJECTIVE: Objective of this open dermocosmetic study was to investigate the efficacy and tolerability of a skin care product containing the anti-inflammatory licochalcone A and the TRPV1 antagonist trans-t-butylcyclohexanol in subjects with sensitive skin prone to redness and rosacea.
METHODS: 1221 subjects with sensitive skin and rosacea stage 0-II applied the test product twice daily for 4 weeks. Clinical assessment of sensitive skin and rosacea symptoms were performed at baseline and after 4 weeks. Additionally, at treatment end the test subjects filled a self-assessment questionnaire.
RESULTS: After 4 weeks of application, both, clinical and subjective assessment have shown improvement of all symptoms of sensitive skin and rosacea in a significant number of subjects (P less than 0.001). The test product was efficacious and very well tolerated also when used in conjunction with pharmacological treatments of the skin condition under scrutiny.
Conclusions: The study confirmed the good tolerability and efficacy of the skin care product in the management of sensitive skin prone to redness and rosacea when used alone or in combination with other therapies.
J Drugs Dermatol. 2017;16(6):605-611.
Brian Berman MD PhD,a Glynis R. Ablon MD,b Neal D. Bhatia MD,c Roger I. Ceilley MD,d David J. Goldberg MD JD,e Mark S. Nestor MD PhD,a and Susan H. Weinkle MDf| |
Dermatologists treat actinic keratosis (AK) primarily because these lesions have the potential to progress to invasive squamous cell carcinoma. Patients, on the other hand, generally seek treatment to remove the lesions and achieve an improved appearance of their skin following treatment. In selecting a treatment option for AK, dermatologists should consider post-treatment cosmesis, because cosmetic outcomes differ across AK treatments. To obtain expert opinion on the cosmetic sequelae related to chronically photodamaged skin and the treatment of AK, an expert panel meeting among dermatologists was conducted in February 2016. These experts reviewed current treatment options for photodamage, including AK, and discussed the relative merits of the various cosmetic assessments commonly used by investigators and patients in both clinical trial and dermatology practice settings. A main goal of the expert panel meeting was to propose assessment tools that could be specifically designed to characterize cosmesis results after treatment of AK. The panel agreed that existing tools for measurement of cosmetic outcomes following treatment of photodamage could also be used to evaluate cosmesis after treatment of AK. Digital photography is probably the best method used for this, with validation by other technologies. Better measurement tools specifically for assessing cosmesis after AK treatment are needed. Once they are developed and validated, regulatory agencies should be educated about the importance of including cosmetic outcomes as a component of product labeling.
J Drugs Dermatol. 2017;16(3):260-265.
Neocollagenesis in Deep and Superficial Dermis by Combining Fractionated Q-Switched ND:YAG 1,064-nm With Topical Plant Stem Cell Extract and N-Acetyl Glucosamine: Open Case Series
Kavita Beri MDa and Sandy S. Milgraum MDb| |
METHOD: Six healthy females (Skin types III - V) were selected for the study with mean average age of 56 years +/- 11 years. The rhytides on the face and neck were assessed using a comprehensive grading scale. Patients were then divided into two groups, one received only laser treatment with the fractionated QSW 1,064 nm laser and the other group received combined treatment with the laser and topical. Patients were assessed again at 4 and 8 weeks.
RESULTS: We observed an enhanced anti-aging effect of the laser in the patients with combined treatment.
DISCUSSION: Understanding the effect of this novel laser therapy on human stem cells and investigating the basis of its synergistic effect with plant stem cell extract and NAG will lead us to better understand stem cell activity. Non-ablative tissue regeneration is the next step in providing optimal anti-aging treatments.
J Drugs Dermatol. 2015;14(11):1342-1346.
Safety and Effectiveness of Ustekinumab for Treatment of Moderate to Severe Psoriasis: A Prospective Study in a Clinical Setting
Alejandro Molina-Leyva MD, Husein Husein-Elahmed MD, Ramon Naranjo-Sintes PhD,
and Jose Carlos Ruiz-Carrascosa MD
OBJECTIVE: To assess the utility of ustekinumab in a psoriasis unit.
METHODS: Analysis of the prospective data gathered during the follow-up of 30 consecutive psoriasis patients treated with ustekinumab at a single referral centre. Three effectiveness endpoints were defined 12 weeks, 28 and “long-term treatment”. The main outcome measure was improvement from baseline PASI at week 28 and at a point of adjustment of prolonged treatment signed as “long-term treatment”.
RESULTS: Overall 82.1% and 42.8% patients achieved respectively PASI75 and PASI90 response rates at week 28. Long-term treatment maintained efficacy outcomes 81.5% and 40.7% PASI75 and PASI90, respectively were observed. At week 28, patients naïve to TNFα- blockers agents and patients with a baseline PASI >10 had better PASI75 and PASI90 response rates than previously treated patients.
CONCLUSIONS: In clinical practice, the efficacy and patient adherence to ustekinumab are excellent and even better to the data obtained in clinical trials. Clinical indicators of psoriasis severity: previous treatments with tumor necrosis factor α blockers agents and active treatment beside small increases in PASI determine a delayed maximal response.
J Drugs Dermatol. 2014;13(8):971-974.
Guy F. Webster MD PhD| |
J Drugs Dermatol. 2011;10(6):636-644.
Long-term Efficacy and Safety of TopicalPRK 124 (0.125%) Lotion (Pyratine-XR) in theTreatment of Mild-to-Moderate Rosacea
Anne Marie Tremaine MD, Arisa Ortiz MD, Laila Elkeeb MD, Minh Tran, Gerald Weinstein MD| |
Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design
William C. Ports DVM,a Steven R. Feldman MD PhD,b Pankaj Gupta PhD,a Huaming Tan PhD,a Theodore R. Johnson PhD,c and Robert Bissonnette MDd| |
J Drugs Dermatol. 2015;14(8):777-784.
Rosacea is a common disorder that is both under recognized and undertreated. Prevalence figures indicate that it may be present in 1 of every 10 adults in a primary care waiting room. Untreated, patients with rosacea can suffer significant emotional, workplace, and social impairments. While rosacea has been recognized since ancient times, only recently have investigators begun to identify the pathophysiologic elements responsible for the characteristic erythema, flushing, dysesthesias, and papulopustular manifestations of the disease. Although the etiology of rosacea is unclear, inflammation appears to be a central element. Experimental evidence suggests that abnormalities of the skin's innate and adaptive immune responses may play pivotal roles. Once recognized, effective topical and systemic therapies can be prescribed to lessen the impact of the disease on the patient's life. Although initially administered in an empiric fashion, it now seems clear that the role of antibiotics in patients with rosacea depends upon their anti-inflammatory rather than their antimicrobial properties. Consequently, practitioners have the opportunity to practice good antibiotic stewardship when treating the disease, particularly with systemic therapies. Therapy with subantimicrobial dosing and with topical treatments can modulate the inflammation of rosacea without exerting antibiotic pressure responsible for the emergence of antibiotic resistance.
J Drugs Dermatol.2012;11(6):725-730.
Superior Efficacy of an Herbal-based Cosmeceutical Compared With Common Prescription and Cosmetic Antiaging Therapies
Carl R. Thornfeldt MDa and Ronald L. Rizer PhDb| |
MATERIALS AND METHODS: Six randomized split face, double blind, prospective, controlled clinical trials involving a total of 110 subjects compared a cosmeceutical blend of novel herbs in regimens consisting of one to three products to several common antiaging topical treatments. These comparative products include prescription tretinoin, physician strength idebenone, kinetin, polyhydroxy, lactic and glycolic acids in reversing signs of photoaging.
RESULTS:The novel cosmeceutical blend regimen showed superior efficacy and safety in all six trials.
DISCUSSION: These trials substantiate that herbs not used in common antiaging products effectively and safely mitigate and reverse photoaging signs and symptoms. The novel concept of treating photoaging and preventing its progression by repairing and optimizing the stratum corneum barrier, while reversing and inhibiting chronic cutaneous inflammation, has now been proven.
J Drugs Dermatol. 2016;15(2):218-223.
Hypertrophic Surgical Scars: A Pilot Study Supriya G. Bellew MD, Margaret A. Weiss MD, Robert A. Weiss MD| |
Result: Mean improvement on a 0 to 3 oint scale was 2.2(55%) after the first LPDL treatment and 3.2 (80%) after the second. Mean improvement was 1.8(45%) after the first IPL treatment and 2.6(65%) after the second. Differnces in improvement between the LPDL and IPL sides were not statisdtically significant. Patients rated IPL. as more painful thatn LPDL. The incidence of post-treatment pupura was lower with IPL.
Conclusions: This pilot study suggests that LPDL and IPL are equally effective in improving the appearance of hypertrophic surgicak scars. IPL offers a movel method of treating scars that minimizes the risk of purpura.
Erin Gilbert MD PhDa and Lucia Calvisi MDb| |
OBJECTIVE: To analyse and discuss the approach to midface as well as lip and perioral volume restoration by two independent dermatologists working in the US and Italy.
METHODS: Seven patients were selected for discussion and divided into two groups: 1) those requiring midface volumization and 2) those undergoing perioral or lip volume replacement. Patients in the midface group were injected with Juvéderm Voluma® XC, Juvéderm® Volift® with lidocaine, Restylane- L®, Perlane-L® or Radiesse®. Patients in the perioral and/or lip group were injected with Juvéderm® Volbella™, with lidocaine, or Belotero Balance™. Patients were photographed before and immediately after injection to evaluate aesthetic outcomes. In each case, filler selection was based upon patient characteristics, anatomical considerations and inherent filler properties.
Results: All patients were extremely satisfied with their treatments. There were no significant immediate or delayed complications following treatment with any of the dermal fillers used.
CONCLUSIONS: Volume restoration in the midface and perioral or lip region can be effectively achieved using a variety of dermal fillers. The dermal filler portfolio available in Europe is exponentially larger than that in the US. Product selection in either market is ultimately the result of the physician’s experience injecting each dermal filler, as well as his or her personal preferences.
J Drugs Dermatol. 2014;13(1):67-74.
Clinical Equivalence of Conventional OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (Neurotoxin Free From Complexing Proteins - 150 KDa): 2013 Multidisciplinary French Consensus in Aesthetics
Bernard Poulain PhD,a Patrick Trevidic MD,b Micheline Clavé MD,c Claude Aharoni MD,d Martine
Baspeyras MD,e Patrick Bui MD,f Hugues Cartier MD,g Marie-Hélène Charavel MD,h Pierre Coulon MD,i
Serge Dahan MD,j Jean-Marie Dallara MD,k Denis Delonca MD,l Laurent Dumas MD,m
Eric Essayagh MD,n Olivier Galatoire MD,o Nicolas Georgieu MD,p Yann Grangier MD,q
Philippe Humbert PhD,r Anne Le Pillouer-Prost MD,s and Alain Mojallal MDt
J Drugs Dermatol. 2013;12(12):1434-1446.
Selective Radiofrequency Therapy as a Non-Invasive Approach for Contactless Body Contouring and Circumferential Reduction
Kateřina Fajkošová MUDr,a Alena Machovcová MD PhD MBA,b,c Meltem Onder MD,d and Klaus Fritz MDd,e| |
J Drugs Dermatol. 2014;13(3):291-296.
Efficacy and Safety of Minoxidil 2% Solution in Combination With a Botanical Hair Solution in Women With Female Pattern Hair Loss/Androgenic Alopecia
Amy McMichael MD,a Hanh Pham MA,b Erika von Grote PhD,c and Matthew H. Meckfessel PhDc| |
J Drugs Dermatol. 2016;15(4):398-404.
Microbiome of Affected and Unaffected Skin of Patients With Atopic Dermatitis Before and After Emollient Treatment
Gilberto E. Flores PhD,a Sophie Seité PhD,b Jessica B. Henley MS,c Richard Martin MS Ing,d
Hana Zelenkova MD,e Luc Aguilar PhD,f Noah Fierer PhDa,c
J Drugs Dermatol. 2014;13(11):1365-1372.
Ronen Alkalay MD MBA, Joseph Alcalay MD, Alex Maly MD, Arieh Ingber MD, Clemens Fritsch MD, Thomas Ruzicka MD PhD, Claes D Enk MD PhD| |
Objective: To ascertain whether fluorescence imaging improves the clinical tumor border assessment by investigating the consistency between tumor size determination by MMS, clinical assessment, and fluorescence imaging.
Methods: Eighteen patients with histologically verified nodular BCCs on the face scheduled for MMS were included in the study. The night before the surgical procedure, 5-aminolevulinic methyl ester cream was applied to the lesion. The following morning, tumor borders were determined clinically (clinical size), after illumination with Wood’s light (fluorescence size), and by the tumor defect left on the skin surface following removal of the MMS specimen (Mohs size).
Results: The median tumor sizes were 93.05 mm2 (Mohs size), 61.05 mm2 (clinical size), and 72.75 mm2 (fluorescence size). The interclass correlation coefficients between Mohs size and fluorescence size was 0.984 and Mohs size and clinical size was 0.752.
Conclusion: Tumor border estimation by fluorescence imaging and clinical assessment underestimate the genuine tumor size determined by MMS; however, the fluorescence size showed a higher degree of consistency with the Mohs size than did the clinical size.
Increased Prevalence of Psychiatric Disorders and Health Care-Associated Costs Among Patients With Moderate-to-Severe Psoriasis
Methods: In a retrospective, matched case-control study, data for services from nearly 75 health care plans in the United States (U.S.) were collected from PharMetrics Patient Centric Database using International Classification of Diseases, Ninth Revision Clinical Modification codes, identifying a total of 39,855 adults with moderate-to-severe psoriasis (n=7,971) and without (controls; n=31,884). Patients with psoriasis had at least one psoriasis health care claim and received at least one medical/prescription treatment claim within two consecutive years. Psychiatric comorbidities and treatments among patients and controls were determined by claims. Annual inpatient, outpatient, emergency room, and prescription costs for those with and without psoriasis and those with and without psychiatric disorders were compared.
Results: Patients had significantly higher prevalence of anxiety (6.9% versus 4.4%), depression (9.2% versus 5.3%), bipolar disorder (1.1% versus 0.5%), or delirium (0.3% versus 0.1%; P<0.05) than controls (others P<0.0001). Significantly higher proportions of patients with psoriasis received antidepressants (6.1% versus 0.9%), anxiolytics (5.0% versus 0.8%), or antipsychotics (5.9% versus 0.9%) compared with controls (each P<0.0001). Total health care costs for patients with psoriasis (US $11, 369.47) were significantly higher than for controls ($3,427.60; P<0.001). Psoriasis patients with psychiatric disorders had significantly higher health care costs ($17,637.66) than those without psychiatric disorders ($10,362.80; P<0.001).
Conclusion: The prevalence of psychiatric disorders is higher in patients with moderate-to-severe psoriasis than in controls. Annual health care costs are higher in psoriasis patients with psychiatric disorders than in those without psychiatric disorders.
J Drugs Dermatol. 2011;10(8):843-850.
The Efficacy and Tolerability of Tazarotene Foam, 0.1%, in the Treatment of Acne Vulgaris in 2 Multicenter, Randomized, Vehicle-Controlled, Double-Blind Studies
Steven R. Feldman MD PhD,a Cary P. Werner MS,b and Alessandra B. Alió Saenz MDb| |
OBJECTIVE: To evaluate efficacy and tolerability of tazarotene foam, 0.1% in adults and adolescents with acne vulgaris.
METHODS: Two randomized, double-blind, vehicle-controlled, parallel-group studies were conducted at 39 centers in the United States and Canada. The first study involved 744 participants and the second 742, aged 12 to 45 years, who were randomized to receive treatment with either tazarotene foam, 0.1% or vehicle foam once daily for 12 weeks. Lesion counts, Investigator's Static Global Assessments (ISGA), and Subject's Global Assessments (SGA) were evaluated at baseline and weeks 2, 4, 8, and 12. Tolerability was monitored throughout the study.
RESULTS: At week 12 in both studies, treatment with tazarotene foam led to greater decreases from baseline in mean absolute and percentage change in lesion counts (noninflammatory, inflammatory, and total), greater proportion of participants with ≥2-grade improvement in ISGA score, and greater proportion of participants with ISGA score of 0 or 1 than vehicle treatment (P<.001 for all). Only application-site skin irritation and dryness were reported by >5% of participants in active treatment groups in both studies.
LIMITATIONS: The efficacy and tolerability of tazarotene foam were not compared directly with those of other formulations.
CONCLUSION: Tazarotene foam, 0.1% significantly reduced the number and severity of acne lesions after 12 weeks and had a safe and acceptable tolerability profile.
J Drugs Dermatol. 2013;12(4):438-446.
Topical Treatment With an Agent Disruptive to P. acnes Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial
Michael J. Bernhardt MDa and Matthew F. Myntti PhDb| |
J Drugs Dermatol. 2016;15(6):677-683.
Eric Lee MD, Mina Zarei MD, Charlotte LaSenna BS, Gabriel Villada MD, and Paolo Romanelli MD| |
METHODS AND MATERIALS: A search of the University of Miami Dermatopathology database was performed to identify all available patient specimens within the various subtypes of psoriasis. IL-17A IHC staining was performed using 4 μm paraffin skin sections. 1:25 dilution of IL-17A antibody was used. Stained slides were analyzed using a semi-quantitative scoring method ranging from negative to three plus.
RESULTS: Palmoplantar and pustular psoriasis cases showed consistently strong IL-17A staining. Plaque psoriasis cases showed intermittent to strong IL-17A staining. The results in the scalp and guttate psoriasis cases showed variable results.
CONCLUSION: The results of our study suggests the significant role of the cytokine IL-17A in the development of palmoplantar and pustular psoriasis. However, scalp and guttate subtypes showed variable expression from negative to strongly positive, which demonstrates a case by case basis expression of IL-17A. Therefore, exploring the IHC characterization of subtypes of psoriasis will help dermatologists better understand the pathogenesis of each subtype and help clinicians optimize treatments.
J Drugs Dermatol. 2015;14(10):1133-1136.
Zoe Diana Draelos MD| |
AIM: This research evaluated the efficacy of a three step acne treatment regimen containing stabilized botanical anti-inflammatory ingredients as compared to a currently marketed acne regimen.
METHOD: 80 female/male subjects 12+ years with mild to moderate acne (at least 10 inflammatory and 10 non-inflammatory lesions) were enrolled for 12 weeks and randomized to use the study botanical anti-inflammatory acne regimen or the traditional benzoyl peroxide comparator. Evaluations included investigator global assessment, investigator tolerability assessment, acne lesion characteristics (erythema, lesion height, diameter of inflammation, and amount of pus), subject product assessment, and digital photos at baseline, 2, 4, and 12 weeks.
RESULTS: The botanical regimen outperformed the comparator in terms of target lesion erythema, height, inflammation, and pus at weeks 2 and 4, perhaps due to anti-inflammatory ingredients, however parity was reached between the two products by week 12. No difference in lesion counts between the two groups was noted at week 2, however by week 4, there was a lower lesion count with the study regimen in terms of closed comedones (P<0.001) and inflammatory (P=0.016) lesions than the comparator. This statistically significant difference continued into week 12 with a reduction in closed comedones (P=0.006) for the study regimen.
CONCLUSION: Modern OTC cosmetic formulation ingredients including emollients, anti-inflammatory/antioxidants, and sensitive skin modulators provided an improved skin appearance, less lesional erythema, and a better overall appearance in subjects with acne treated for 12 weeks.
J Drugs Dermatol. 2015;14(12):1418-1421.
Linda Stein Gold MD,a William P. Werschler MD,b Jennifer Mohawk PhDc| |
BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.
METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.
CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.
Clinicaltrials.gov registry: (NCT01880320)
J Drugs Dermatol. 2017;16(6):582-589.
Reduced Appearance of Under-eye Bags With Twice-daily Application of Epidermal Growth Factor (EGF) Serum: A Pilot Study
Rachel Seidel BAa and Ronald L. Moy MD FAADa,b| |
OBJECTIVE: We studied the ability of a topical serum containing epidermal growth factor (EGF) to minimize the appearance of under-eye bags.
METHODS: A single-center clinical trial was performed on eighteen volunteer male and female patients with under-eye bags. Subjects applied EGF serum to the infraorbital area twice daily for 12 weeks. At each visit, subjects were evaluated using clinical photography and written self-assessment. A grade on the Merz Infraorbital Hollowness Scale was also given and two independent, blind investigators assigned an Investigator’s Global Assessment (IGA) score. At the trial’s end, patients shared their final evaluation and perception of results with a questionnaire.
RESULTS: Sixteen subjects completed the trial. The final average Merz grade was 1.63 (SEM = .273), statistically significantly lower than the mean baseline average of 2.06 (SEM = .232) (P = .0019). A reduction in average IGA score was also significant (P < .0001). Average initial IGA was 2.75 (SEM = .270) and average final IGA was 2.00 (SEM = .310). All but two subjects reported improvement at the final visit. Improvement was quantified as 76-100% by two subjects, 50-75% by three subjects, and 25-49% by nine subjects. Eleven subjects classified their under-eye bags as milder at the end of the trial compared to the first visit. Seven subjects reported greater satisfaction with their overall facial appearance. Of the subjects who had used other topical treatments in the past, two reported the serum to be “significantly better” and four said it was “better” in treating their under-eye bags.
CONCLUSION: Our results offer evidence that topical EGF can reduce the appearance of under-eye bags.
J Drugs Dermatol. 2015;14(4):405-410.
Steven R. Feldman MD PhDa and Diana M. Chen MDb| |
Background: Products that may cause irritation are widely used to treat acne. Irritation has the potential to reduce treatment adherence.
How patients manage irritation and dryness is not well characterized.
Objectives: To study self-reported irritation, its impact and coping mechanisms in patients who had been treated for acne with a clindamycin-5% benzoyl peroxide (BPO) product.
Methods: An Internet-based survey of 200 subjects, aged 15-40 years who had used a clindamycin-5% BPO fixed combination product in the last six months on at least 50 percent of their face, at least five days per week.
Results: The majority of subjects (57%) had moderate acne, 28 percent had severe acne. Bothersome side effects of the clindamycin- 5% BPO combination included dry skin (55%), flaky/peeling skin (45%), irritated skin (44%), itchy skin (39%) and redness (37%). As a result, subjects used the product only as a spot treatment (33%), only when breakouts seemed worse (28%), or less often than recommended (32%); stopped using from time to time (32%); switched to a different prescription medication and/or an over-thecounter acne product (28%); or stopped using altogether (10%). 41 percent of subjects reported using moisturizers to counteract dryness and redness.
Limitations: We queried patients concerning use of combination clindamycin/BPO products and not other products.
Discussion: Irritation to clindamycin-5% BPO is a common problem that reduces patients' use of the medication. Strategies to improve treatment include communication with patients on possible side effects, providing written instruction on how to manage irritation and dryness and consideration of alternative topical treatments and treatment regimens.
J Drugs Dermatol. 2011;10(6):605-608.
Rapid Treatment of Mild Acne With a Novel Skin Care System Containing 1% Salicylic Acid, 10% Buffered Glycolic Acid, and Botanical Ingredients
Ashish C. Bhatia MDa,b and Felipe Jimenez PhDc| |
J Drugs Dermatol. 2014;13(6):678-683.
Mingliang Zhang PhD,a Chureen Carter PharmD MS,a William H. Olson PhD,b Michael P. Johnson MS,c Susan K. Brenneman PT PhD,c Seina Lee PharmD MS,d Kamyar Farahi PhDe| |
J Drugs Dermatol. 2017;16(3):220-226.
A Controlled Comparison Study of Topical Fluourouracil 5% Cream Pre-Treatment of Aminolevulinic Acid/Photodynamic Therapy for Actinic Keratosis
Emil A. Tanghetti MD, Carolyn Hamann MBA, and Margo Tanghetti BS| |
METHODS: This was an investigator-blinded randomized study in which 30 patients were randomized 1:1:1 into the following groups: Group 1 patients pretreated for 6-7 days with 5-FU, ALA applied with incubation of 2 hours, ALA removed with wet gauze, illuminated treated areas with 10 J/cm2 with Blu-U device; Group 2 patients treated with 5-FU BID for 6-7 days and no ALA/PDT; Group 3 patients received no pretreatment, ALA applied with incubation of 2 hours, ALA removed with wet gauze, illuminated treated areas with 10 J.cm2 with Blu-U device. Patients were seen at screening/baseline, treatment for ALA/PDT, 24 hours post treatment, 1 week post treatment and 3 months post treatment. All subjects were then given a re-challenge course of 5-FU for 6 days and reassessed.
RESULTS: AK counts in all groups were dramatically decreased and similar at 1 and 3 months post treatment. The re-challenge brought a significant difference with many subclinical lesions in the area of activity in the ALA and 5-FU alone groups.
CONCLUSIONS: All three arms appeared equal in treating visible AKs. These data strongly suggests a synergistic role of 5-FU with ALA/PDT over ALA/PDT or 5-FU alone in treating the subclinical lesions demonstrated on a 5-FU re-challenge. Treatment of these subclinical lesions should result in a longer remission. The data also suggests that a 5-FU re-challenge could be a clinical tool to judge the efficacy of treatment for AK if these subclinical lesions are proven to be an AK precursor.
J Drugs Dermatol. 2015;14(11):1241-1244.
Topical Tacrolimus 0.1% Improves Symptoms of Hand Dermatitis in Patients Treated With a Prednisone Taper
Jennifer Krejci-Manwaring MD, Martha Ann McCarty MS PA-C, Fabian Camacho MS MA, Janeen Manuel PhD,Jennifer Hartle MPH, Alan Fleischer Jr MD, Steven R. Feldman MD PhD| |
Objective: To evaluate symptoms of hand dermatitis in subjects treated with a prednisone taper combined with topical tacrolimus 0.1% ointment versus vehicle.
Methods: Thirty-two subjects with moderate to severe hand dermatitis were enrolled in a randomized double-blind controlled trial. Subjects received a 3-week taper of prednisone and was randomized 2:1 to apply topical tacrolimus or its vehicle twice daily for 12 weeks. Disease severity was evaluated at baseline and at 5 follow-up visits (weeks 1-14). Any occurrence of relapse was recorded by patients.
Results: Twenty-two of the 32 subjects (69%) had relapse of their disease. The mean time to recurrence for tacrolimus versus vehicle was 48 versus 39 days, respectively (P=.78). A greater improvement of induration (P=.003) and scaling (P=.003) for patients with tacrolimus compared to vehicle was detected, as well as subjective improvement (%) from week 1 to week 12 (P=.04) compared to vehicle. Improvement in erythema (P<.0001), fissuring (P=.0003), pruritus (P=.06), and investigator’s global assessment (P<.0001) with tacrolimus was not found to exceed improvement with vehicle.
Limitations: Small sample size provides limited power to detect differences in response.
Conclusions: Topical tacrolimus improves induration and scaling, and there is a trend suggesting it prolongs the time to recurrence.
Medication Choice and Associated Health Care Outcomes and Costs for Patients With Acne and Acne-Related Conditions in the United States
Palak Patel MS,a Hsien-Chang Lin PhD,b,c Steven R. Feldman MD PhD,d Alan B Fleischer Jr MD,d Milap C. Nahata MS PharmD,e Rajesh Balkrishnan PhDb,c| |
Background: Acne is a common condition for which multiple treatment options are available. The patterns of pharmacotherapy for
acne and similar conditions, and the effect of those patterns on cost, are not well characterized.
Objective: This study examined the impacts of patient demographics and medication choices on patients' health status and associated medication costs.
Methods: A retrospective cross-sectional study was conducted using the 2007 Medical Expenditure Panel Survey (MEPS) database. Information on patient demographics, health status, medication utilization and medication costs was obtained from the database representing 3,784,816 patients with acne and similar conditions.
Results: Weighted multiple linear regression analyses indicated that the use of topical retinoids was preferred in combination with other treatments rather than as monotherapy. Oral antibiotics were widely prescribed and their use was associated with a significant decrease in total annual prescription spending. Use of oral retinoids and oral contraceptives increased the annual prescription costs significantly. Increase in annual drug refills was not associated with the improvement in health status.
Conclusion: We observed an association with medication choice for acne and acne-related conditions on medication spending. Pharmacologic treatment of acne significantly adds to acne-related annual healthcare costs compared to non-pharmacologic treatment.
J Drugs Dermatol.2011;10(7):766-771.
Cost Per Additional Responder Associated With Ixekizumab and Etanercept in the Treatment of Moderate-to-Severe Psoriasis
Steven R. Feldman MD PhD,a Shonda A. Foster PharmD MS,b Baojin Zhu PhD,b Russel Burge PhD,b,c Sarah Al Sawah PhD,b and Orin M. Goldblum MDb| |
BACKGROUND: Newer psoriasis treatments can achieve greater levels of effcacy than older systemic therapies; however, current pso-riasis costs are substantial. We sought to estimate costs per additional responder associated with ixekizumab and etanercept, versus placebo, using effcacy data from phase 3 clinical trials (UNCOVER-2 and UNCOVER-3).
METHODS: In UNCOVER-2/UNCOVER-3, patients received subcutaneous placebo, etanercept 50 mg twice weekly (BIW), or ixekizumab one 80 mg injection every 2 weeks (Q2W) after a 160-mg starting dose. Twelve-week induction-phase Psoriasis Area and Severity Index (PASI) 75, PASI 90, and PASI 100 response rates for ixekizumab, etanercept, and placebo were obtained from pooled data from the overall and United States (US) subgroup intention-to-treat (ITT) populations, and used to calculate numbers needed to treat (NNTs) to achieve one additional PASI 75, PASI 90, or PASI 100 response for ixekizumab Q2W and etanercept BIW versus placebo. Twelve-week drug costs per patient were calculated based on the UNCOVER-2/UNCOVER-3 dosing schedule and wholesale acquisition costs. Mean costs per additional responder for PASI 75, PASI 90, and PASI 100 for each treatment versus placebo were calculated for pooled UN-COVER-2/UNCOVER-3 overall and US subgroup ITT populations.
RESULTS: Pooled overall ITT population: costs per additional PASI 75, PASI 90, or PASI 100 responder were US $37,540, US $46,299, or US $80,710 for ixekizumab Q2W and US $57,533, US $120,720, or US $404,695 for etanercept BIW, respectively. US subgroup ITT population: costs per additional PASI 75, PASI 90, or PASI 100 responder were US $38,165, US $49,740, or US $93,536 for ixekizumab Q2W and US $69,580, US $140,881, or US $631,875 for etanercept BIW, respectively.
CONCLUSIONS: Twelve-week costs per additional responder were lower for ixekizumab Q2W than for etanercept BIW across all levels of clearance (PASI 75, PASI 90, and PASI 100) in the pooled UNCOVER-2/UNCOVER-3 overall and US subgroup ITT populations.
J Drugs Dermatol. 2017;16(12):1246-1252.
Topical Desoximetasone 0.25% Spray and Its Vehicle Have Little Potential for Irritation or Sensitization
Anish Nadkarni BS, Mohammed D. Saleem MD, and Steven R. Feldman MD PhD| |
BACKGROUND: Topical corticosteroids are the most common dermatologic medications and are available in numerous different vehicles. Adherence is limited by traditional vehicles because they are messy and time consuming to apply. The preferred spray formulations have the advantage of being applied with ease, resulting in improved adherence and subsequently improved psoriasis. One limitation of topical treatments, especially spray vehicles, is the potential for irritation and sensitization.
OBJECTIVE: To evaluate the irritation and sensitization potential of topical desoximetasone spray formulation.
METHODS: A multicenter, double-blinded, randomized, controlled study assessed the irritancy and sensitization of 0.25% and 0.05% topical desoximetasone spray. Controls included vehicle, a positive control (0.1% sodium lauryl sulfate), negative control (0.9% saline), and an active comparator control (clobetasol spray). The primary outcome of the study was to evaluate the difference in mean cumulative irritation and potential sensitization response of desoximetasone 0.25% and 0.05% topical sprays.
RESULTS: Of the 297 enrolled, 269 completed the study per protocol for the irritation phase and 250 completed the protocol for the sensitization phase. At 22 days, desoximetasone 0.25 and 0.5% spray were less irritating than clobetasol 0.05% spray; mean irritation score difference of -0.46 and -0.57, respectively. Median total irritation score over the 22 days was 0 for all products. No subjects demonstrated any sensitization reaction to any of the six products. No serious adverse reactions were reported.
LIMITATIONS: Selection bias, use of a healthy population, limits the external validity. In addition, the duration of the study was short lived, unlike numerous inflammatory skin diseases. Conclusions: Desoximetasone spray has little potential for irritation or sensitization. The availability of another spray option for patients desiring less messy treatment may facilitate better adherence and treatment outcomes.
J Drugs Dermatol. 2017;16(8):755-758.
Nevien A. Sami PhD, Abeer T. Attia PhD, Ashraf M. Badawi| |
Objectives: To evaluate the effectiveness of pulsed dye laser (PDL), intense pulsed light (IPL) and light-emitting diode (LED) phototherapy for the treatment of moderate to severe acne vulgaris.
Methods: Forty-five patients with moderate to severe acne were randomly divided into 3 equal groups. Group 1 was treated with a PDL, group 2 was treated with IPL, and group 3 was treated with a blue-red combination LED. Treatment was continued until a ≥90% clearance of patient lesions was achieved. Clinical assessments were conducted before starting treatment, at 1 month as a midpoint evaluation, and after the final treatment session.
Results: Patients treated with the PDL reached a ≥90% clearance of their inflammatory lesions after a mean of 4.1±1.39 sessions, while patients treated with IPL required a mean of 6±2.05 sessions. Patients treated with the LED required a mean of 10±3.34 sessions. At the mid-point evaluation, the percent reduction in acne lesions treated with the PDL was 90% or more, in cases of IPL and the LED, the percent reductions were 41.7% and 35.3%, respectively. Laser and light phototherapy sessions were well tolerated with minimal adverse events experienced as being mild and usually self-limiting.
Conclusions: The encouraging results of the present study contributes evidence of phototherapy as useful therapeutic option for treatment of moderate to severe acne, and validates further studies to evaluate treatments with a larger number of patients and for a longer period of follow-up.
A Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Calcipotriene Foam, 0.005%, vs Vehicle Foam in the Treatment of Plaque-type Psoriasis of the Scalp
Steven R. Feldman MD PhD,a William J. Eastman MD,b Thomas Brundage MS,b and Mary Mills BSb| |
OBJECTIVES: To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.
METHODS: Subjects (n=363) were randomized into an 8-week, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of calcipotriene foam, 0.005% (NCT01139580). Primary end point was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement. Body involvement, target lesion score, and improvement for erythema, scaling, and plaque thickness were also assessed.
RESULTS: At week 8, more subjects in the calcipotriene foam, 0.005% group (40.9%) met the primary end point vs the vehicle foam group (24.2%; intent-to-treat [ITT] population; P<.001); a significant difference between groups was also observed at weeks 2 (P=.041) and 4 (P<.001). No significant difference was observed between treatment groups for ISGA of body psoriasis (ITT population; P=.544). In the per-protocol population, but not the ITT population, more subjects in the calcipotriene foam, 0.005%, group than the vehicle foam group met the secondary end points for scaling (P=.019) and plaque thickness (P=.027). Incidence of adverse events in both treatment groups was low; calcipotriene foam, 0.005%, was associated with erythema. Limitations: An 8-week study provides limited safety and efficacy data.
CONCLUSION: Calcipotriene foam, 0.005%, was more effective than vehicle foam for improving scalp psoriasis over an 8-week period, with improvements evident from week 2, and had a similar safety profile to vehicle foam.
J Drugs Dermatol. 2013;12(3):300-306.
Skin Rejuvenation in Asian Skin: The Analysis of Clinical Effects and Basic Mechanisms of IntensePulsed Light
Yujie Feng, Junying Zhao, Michael H. Gold MD| |
Objectives: The objective of this clinical trial was to evaluate the effects and the mechanism of action of an IPL by comparing clinical photographs and biopsy results before and after treatment.
Methods: A total of 58 patients were treated using a new IPL device. Clinical photographs were taken before treatment and compared to those taken 3 weeks after the treatment. Also, 4 cases had pathological analyses of tissues that were stained by haematoxylin-eosin and Uana orcein. Immunohistology of human collagen of types 1 and 3 and quantitative analyses of elastin and collagen were performed by a poly-functional digital image light microscope; a transmission electron microscope was used for 2 of the cases to look for additional changes.
Results: After 3 treatments, 62.1% of the patients showed improvement in wrinkles and skin texture. Pigmentation improved in 84.6% of the patients, and a reduction in telangiectasis was seen in 81.25% of the patients. Pathological examination showed that both type 1 and type 3 collagens increased following treatment, but elastin content decreased; however, the elastin fibers were arranged more neatly. In the transmission electron microscope study, the amount of fibroblast activity increased, the fibroblasts were more active, and there were more collagen fibers neatly rearranged within the stroma.
Conclusion: Clinical and pathological studies demonstrated that the IPL was effective in improving wrinkles and skin texture. The mechanism of action may be through the increasing activity of the fibroblasts, hyperplasia of the fibroblasts, and rearrangement of both collagen and elastin within the stroma.
Efficacy and Safety of Ivermectin 1% Cream in Treatment of Papulopustular Rosacea: Results of Two Randomized, Double-Blind, Vehicle-Controlled Pivotal Studies
Linda Stein Gold MD,a Leon Kircik MD,b Joseph Fowler MD,c Jerry Tan MD,d Zoe Draelos MD,e Alan
Fleischer MD,f Melanie Appell MD,g Martin Steinhoff MD,h Charles Lynde MD,i
Hong Liu MSc,j and Jean Jacovella MDk
on behalf of the Ivermectin Phase III Study Group
OBJECTIVE: To demonstrate the efficacy and safety of once-daily ivermectin 1% cream in subjects with moderate to severe PPR.
METHODS: Two identically designed, randomized, double-blind, controlled studies of ivermectin 1% cream (IVM 1%) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR. Efficacy assessments were Investigator's Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their rosacea and completed satisfaction and quality of life (QoL) questionnaires.
RESULTS: In both studies, a greater proportion of subjects in the IVM 1% group achieved treatment success (IGA “clear” or “almost clear”): 38.4% and 40.1% vs 11.6% and 18.8% for vehicle (both P<.001), respectively. Ivermectin was superior to vehicle in terms of reduction from baseline in inflammatory lesion counts (76.0% and 75.0% vs 50.0% for both vehicle groups, respectively). For all endpoints, starting at week 4 and continuing through week 12, IVM 1% was statistically significantly superior (P<.001). Fewer subjects treated by IVM 1% reported dermatologic AEs, and a higher proportion of subjects were observed to have no skin dryness or itching compared to vehicle. Significantly more subjects receiving IVM 1% reported having an “excellent” or “good” improvement, along with an improved QoL.
CONCLUSION: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.
J Drugs Dermatol. 2014;13(3):316-323.
Comparing the Clinical Attributes of AbobotulinumtoxinA and OnabotulinumtoxinA Utilizing a Novel Contralateral Frontalis Model and the Frontalis Activity Measurement Standard
Mark S. Nestor MD PhDa and Glynis R. Ablon MDb| |
Background: Studies on the pharmacodynamics of abobotulinumtoxinA (ABO) and onabotulinumtoxinA (ONA) have produced inconsistent results. This may be due to the lack of objective measurement methods.
Objective: To assess and compare pharmacodynamic attributes, including onset of action, spread and efficacy of ABO and ONA using a novel Frontalis Activity Measurement Standard (FMS) and 4-point Frontalis Rating Scale (FRS).
Methods: Twenty subjects with severe frontalis lines at maximum elevation received equal volumes of ABO or ONA using a dose ratio of 2.5:1 in five injection points on contralateral sides of the frontalis (statistical n=40). Subjects were evaluated using the FMS and FRS for 30 days using pre-defined endpoints for onset and effectiveness. Other assessments included areas of effectiveness and injection pain.
Results: For ABO vs. ONA, the FMS revealed a median Initial Onset of 12 vs. 48 hours (P<0.001), Full Onset of 24 vs. 72 hours (P<0.001) and Complete Onset of three vs. five days (P=0.01). The FRS indicated an Initial Onset for ABO and ONA of 18 hours vs. two days (P=0.002), Full Onset of two vs. three days (P=0.001) and Complete Onset of four days vs. eight days (P=0.01). The FMS showed 90 percent of ABO treatment achieved Complete Efficacy vs. 75 percent for ONO, while 90 percent of ABO treatments reached Complete Efficacy using the FRS vs. 65 percent for ONO. No differences in area of effectiveness or spread were observed. Most subjects (80%) reported ABO injections were less painful than ONA injections (P<0.05).
Conclusion: The FMS appears to be a sensitive, objective tool for measuring ABO and ONA pharmacodynamics. Using a dose ratio of 2.5:1, ABO displayed significantly earlier onset of effect and less injection pain than ONA but similar areas of effectiveness.
J Drugs Dermatol. 2011;10(10):1148-1157.
Safety and Efficacy Evaluation of Pulsed Dye Laser Treatment, CO2 Ablative Fractional Resurfacing, and Combined Treatment for Surgical Scar Clearance
Joel L. Cohen MDa and Roy Geronemus MDb| |
Infliximab is a chimeric monoclonal antibody, which acts by binding to both the soluble and membrane-bound tumor necrosis factor-a. In clinical practice, it is used as either monotherapy or in combination with other systemic therapies, particularly methotrexate. This study reviews clinical response and adverse events in 120 psoriasis patients with moderate-to-severe psoriasis who have received infliximab for a minimum of one year. The medical records of 120 infliximab-treated psoriasis patients at our referral psoriasis clinic in Dallas between 2002-2008 were reviewed for response rates, side effects and concomitant therapies. Of 120 charts reviewed, 112 (93%) patients had plaque type psoriasis, six (5%) had recalcitrant palmoplantar disease and two (1.6%) had severe acropustulosis of Hallopeau. Eighty-four (70%) patients had symptomatic psoriatic arthritis. The mean follow-up time was 2.2±1.1 years. One hundred and nine (91%) of the 120 patients had clearance of their psoriasis (response of more than 90% of initial BSA) at a median time of 12 weeks. Concomitant systemic treatments, primarily methotrexate, were given to 62 (52%) patients. Nineteen patients (16%) discontinued infliximab in the post-one-year treatment period for a variety of reasons, primarily failure to maintain adequate response. One hundred and four (87%) of patients required more than the standard dose of 5 mg/kg every eight weeks to maintain clearance. Infliximab either as monotherapy or in combination with traditional antipsoriatic agents is an effective and well-tolerated treatment option for patients with moderate to severe psoriasis and psoriatic arthritis on therapy for over one year and continuing for the long term.
J Drugs Dermatol. 2011;10(5):539-544.
Ava T. Shamban MD, Mikiko Enokibori MD, Vic Narurkar MD, Donna Wilson RN| |
Methods: In a retrospective multicenter study, clinical data were collected from 56 patients with mild to severe acne. Patients had been treated 2 to 4 times with a portable photopneumatic device (Aesthera PPx, Aesthera Corporation, Pleasanton, CA) that delivers broadband light (400 to 1200 nm) to the treatment site via a hand piece. For 11 of the 56 photographs taken before and after PPx treatment.
Results: For the 56 patients, the median physician-rated clearance increased from 50% after a single treatment to 90% after the fourth treatment, whereas the median patient-rated clearance improved form 50% after a single treatment to 78% after the fourth treatment. On a 4-point scale, both physician-rated and patient-rated median overall satisfaction levels increased from a 3 after a single treatment, to 4 after the second, third, and fourth treatments. Clinically significant adverse events were not observed. For the 11 patients evaluated by photography, the median papule and pustule lesion counts decreased from 2 to 0, respectively. Median acne severity (Burton scale) decreased from 2 before treatment to 1 after the final treatment (scale 1-4). Adverse events were limited to mild erythema.
Conclusion: Photopneumatic technology provides a safe and effective treatment of mild to sever acne vulgaris.
Efficacy and Tolerability of a Fixed Combination of Clindamycin Phosphate (1.2%) and Low Concentration Benzoyl Peroxide (2.5%) Aqueous Gel in Moderate orSevere Acne Subpopulations
Guy Webster MD PhD, Phoebe Rich MD, Michael H. Gold MD, Serena Mraz MD, Barry Calvarese MS, Diana Chen MD| |
Objective: To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations.
Methods: Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator’s global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects’ evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies.
Results: Clindamycin-BP 2.5% gel significantly reduced inflammatory, non-inflammatory and total lesions compared with each active ingredient and vehicle in subjects with moderate acne and compared with vehicle in severe acne subjects at week 12. Significant improvements in evaluator’s global severity score were evident for subjects with moderate acne in the clindamycin-BP 2.5% group compared with each active ingredient and vehicle and compared with vehicle in subjects with severe acne at week 12. Rates of adverse events were low and similar between treatment groups and baseline acne severity.
Conclusion: Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.
Cindy Wassef BA,a Adriana Lombardi MD,b Sairah Khokher MD,c and Babar K. Rao MDc| |
OBJECTIVE: The objective of this review was to describe the various surgical, laser, and alternative therapies available for vitiligo. A literature review was conducted through Pubmed and Ovid using the search terms "Vitiligo treatment”, “Vitiligo surgery”, “Vitiligo laser”. Since no articles were available about needling on both Pubmed and Ovid using the search criteria, individual articles were sought out through Google.
RESULTS: The literature review yielded many possible surgical interventions including autologous mini-punch grafting, suction epidermal blister grafting, split-thickness grafting, and cultured and noncultured melanocyte keratinocyte transfer. Laser options included the helium-neon and xenon-chloride lasers, with tattooing and needling serving as other options. While all the above techniques can provide improvement to pigmentation in vitiliginous patches, physician comfort and experience are important factors with regards to outcome. Our case series of four patients treated with the needling method yielded favorable results, with repigmentation rates ranging from 25-50%, with one patient having 90% repigmentation.
CONCLUSION: There are many surgical, laser, and alternative treatment options available for vitiligo when conventional medical therapy fails or for use in conjunction with medical therapies. Autologous mini punch grafting and needling both have minimal equipment requirements and are easy to learn. Physician experience and comfort play a large role in outcome and availability of services.
J Drugs Dermatol. 2013;12(6):685-691.
Michael T. Jarratt MD,a Terry M. Jones MD,b Joan-En Chang-Lin PhD,c Warren Tong PharmD MS,c David R. Berk MD,c Vince Lin PhD,c and Alexandre Kaoukhov MDc| |
J Drugs Dermatol. 2016;15(10):1250-1259.
A Proposed Method for Upper Eyelid and Infrabrow Tightening Using a Transcutaneous Temperature Controlled Radiofrequency Device With Opaque Plastic Eye Shields
Douglas J. Key MD and Lauren Boudreaux DO| |
Objective: We describe one patient who developed sarcoidosis while being treated for psoriasis with etanercept. We sought to review to previously reported cases and further characterize the nature of this reaction.
Methods: A literature search was performed with the key words "sarcoidosis, sarcoid, etanercept, infliximab, adalimumab, granulomatous, and drug reaction." All relevant cases in the English language were included and evaluated for demographic data, duration of therapy prior to developing sarcoid, duration of sarcoid signs/symptoms, treatments used and time to resolution after discontinuation of the drug.
Results: Including the present case, there are 34 cases of sarcoidosis developing during anti-tumor necrosis factor therapy. All previously reported cases were patients with a primarily rheumatologic diagnosis. In all but one case, discontinuation of the drug resulted in complete resolution of symptoms. The lung and surrounding lymph nodes were the areas most commonly affected. The average amount of time between initiation of therapy and onset of symptoms was 22 months. The average time to resolution of symptoms after discontinuation of the drug was 5.2 months.
Limitations: This is a retrospective case review.
Conclusions: These data indicated that sarcoid is a possible adverse effect of tumor necrosis factor inhibitor therapy that should be noted by dermatologists using these drugs. While it has been reported in the rheumatology literature, it may be under-recognized by dermatologists.
J Drugs Dermatol. 2012;11(5):609-612.
Han-deng Tu MD,a,b,c Yuan-hong Li MD PhD,b Hong-fu Xie MD,a Jia-mei Xiong MD,c Bing Wang MD,b Xue-gang Xu MD,b La-ga Tong MD,b LiLi MD,b Michael H. Gold MD,d and Hong-Duo Chen MDb| |
OBJECTIVE: The objective was to evaluate the efficacy and safety of a dual-wavelength laser device in treatment of neck and facial PWS in a direct side-by-side comparison.
METHODS: Sixteen Chinese patients with neck and/or facial PWSs were enrolled in the study. All lesions were randomly divided into two area, treated area and adjacent untreated area. Five successive treatments using a dual-wavelength laser system (595-nm PDL combined with 1,064-nm Nd:YAG laser) were delivered on treated areas at 4- to 6-week intervals. The adjacent area was not treated as self control. Two blinded dermatologists evaluated the clinical changes by comparing the before and after photos. Erythema index (EI) values were measured with a non-invasive instrument.
RESULTS: After five sessions of treatment, over 62.5% (10/16) patients achieved more than 50% (moderate or significant) improvement. The efficacy maintained at the 3-month follow-up visit. The values of EI on treated area showed a significant decrease. Adverse effects of treated area were limited.
CONCLUSION: Using this split-face module, the dual-wavelength laser system is proved to be effective and well tolerated in treating neck and facial PWSs in Chinese patients. Adverse effects were minimal and acceptable.
J Drugs Dermatol. 2015;14(11):1336-1340.
Efficacy and Safety of Aciclovir Mucoadhesive Buccal Tablet in Immunocompetent Patients With Labial Herpes (LIP Trial): A Double-Blind, Placebo-Controlled, Self-Initiated Trial
Thomas Bieber MD,a Olivier Chosidow MD PhD,b Neil Bodsworth MD,c Stephen Tyring MD,d
Jana Hercogova MD,e Mark Bloch MD,f Matthew Davis MD,g Michael Lewis MD,h
David Boutolleau MD,i Pierre Attali MD MSc,j and the LIP Study Group
METHODS: In this multicenter double-blind placebo-controlled patient-initiated trial, 775 patients with recurrent HL were randomly assigned to either a single application of ABT 50 mg or a matching placebo as soon as prodromal symptoms occurred. The primary endpoint was the time to healing (TTH) of primary vesicular lesion (modified intention-to-treat population). Other endpoints included incidence of blocked episodes, duration of herpes episodes, and incidence and time to next recurrence evaluated during a 9-month follow-up period (intention-to-treat population).
RESULTS: With ABT 50 mg, median TTH of primary vesicular lesion was reduced (7 days vs 7.3 days, P=.015), the incidence of blocked herpes episodes was increased by 24.2% (34.9% vs 28.1%; P=.042), and the median duration of herpes episodes was reduced (5.6 days vs 6.4 days, P=.003). During the 9-month follow-up period, recurrence of herpes lesions was less frequent (64.2% vs 73.6%; P=.027) and delayed (205 days vs 165 days, P=.041) in the ABT 50 mg. Both treatments were safe.
CONCLUSION: A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence and delaying the onset of the next recurrence.
J Drugs Dermatol. 2014;13(7):791-798.
Successful Short-Term and Long-Term Treatment of Melasma and Postinflammatory Hyperpigmentation Using Vitamin C With a Full-Face Iontophoresis Mask and a Mandelic/Malic Acid Skin Care Regimen
Mark B. Taylor MDa, Jamal S. Yanaki MS EdDb, David O. Draper PhDc, Joe C. Shurtz BSc, and Mark Coglianese PhDc| |
Methods: In this study, 35 patients (34 female, 1 male) were treated with a novel full-face iontophoresis mask (FFIM) and a proprietary vitamin C (ascorbyl glucoside) preparation. Patients received one in-office treatment and 12 to 24 at-home treatments over 1 to 2 months in conjunction with a strict maintenance regimen consisting of a mandelic/malic acid skin care regimen, broad-spectrum ultraviolet A/ultraviolet B sunblock, a wide-brimmed hat, and sun-avoidance behavior. Follow-up after the initial in-office treatment ranged from 1 to 54 months (mean, 26 months). Four independent observers graded improvement of melasma and PIH using a 4-point scale. Before the study, high-performance liquid chromatography was used to verify iontophoretic penetration of vitamin C into the skin to a level of 0.2 cm in healthy volunteers (2 male, 2 female).
Results: A mean 73% improvement in abnormal pigmentation was observed at the end of FFIM/vitamin C treatment. Greater than 25% improvement was observed in 32 of 35 patients, and greater than 50% improvement in 22 of 35 patients. Melasma Area and Severity Index scores demonstrated substantial improvement from baseline for all patients, with a mean improvement of 15.7.
Conclusions: Full-face iontophoresis of vitamin C appears to be an effective short-term treatment for melasma and postinflammatory hyperpigmentation. A protocol of strict sun avoidance in combination with a mandelic/malic acid skin care regimen appears to be useful in maintaining the improvement.
J Drugs Dermatol. 2013;12(1):45-50.
Christy C. Riddle MD, Shaundre N. Terrell BS, Molly B. Menser DO, Daniel J. Aires MD,Eric S. Schweiger MD| |
Objective: To review the results of clinical trials and case series with respect to light source, topical photosensitizing agent, adverse events, efficacy and skin type.
Methods: A non-critical review is presented of a PubMed search for studies examining PDT in the treatment of acne vulgaris.
Results: The authors found 21 clinical trials and case series of various designs. Eight studies employed a split-face design comparing photosensitizer to placebo, no treatment or another photosensitizer. Two trials used three test spots and one control spot per patient. Three studies utilized control subjects receiving no photosensitizer with or without light therapy. All 21 studies reported a reduction in inflammatory lesions and/or a significant improvement in acne. The light sources utilized included blue light, pulsed-dye laser (PDL), intense pulsed light (IPL) and red light. Studies comparing the use of PDT to light therapy alone demonstrated greater improvement in treatment groups pretreated with a photosensitizer.
Conclusion: All studies reported reduction in inflammatory lesions or significant improvement in acne. Several studies confirm a light source combined with photosensitizer is superior to light alone. Adverse reactions including photosensitivity, pustular eruptions, and crusting varied among photosensitizers and light sources. PDT appears to be a useful therapeutic option for acne patients who are recalcitrant to standard treatments and poor candidates for systemic retinoids. Further studies are still needed before a consensus protocol can be established. Additional investigations are needed to establish optimal incubation time, activating light source and frequency of treatment.
Contactless Abdominal Fat Reduction With Selective RF™ Evaluated by Magnetic Resonance Imaging (MRI): Case Study
Jeanine Downie MDa and Miroslav Kaspar MDb| |
MATERIALS AND METHODS: Six subjects were treated by a contactless selective radiofrequency device (BTL Vanquish ME, BTL Industries Inc., Boston, MA). The MRI fat thickness was measured at the baseline and at 4-weeks following the treatment. In addition to MRI images and measurements, digital photographs and anthropometric evaluations such as weight, abdominal circumference, and caliper fat thickness measurements were recorded. Abdominal fat thickness measurements from the MRI were performed from the same slices determined by the same tissue artefacts.
RESULTS: The MRI fat thickness difference between the baseline measurement and follow up visit showed an average reduction of 5.36 mm as calculated from the data of 5 subjects. One subject dropped out of study due to non-study related issues. The results were statistically significant based on the Student’s T-test evaluation.
CONCLUSIONS: Magnetic resonance imaging abdominal fat thickness measurements seems to be the best method for the evaluation of fat thickness reduction after non-invasive body shaping treatments. In this study, this method shows average fat thickness reduction of 5.36 mm while the weight of the subjects didn’t change significantly. A large spot size measuring 1317cm2 (204 square inches) covers the abdomen flank to flank. The average thickness of 5.36 mm of the fat layer reduced under the applicator translates into significant cumulative circumferential reduction. The reduction was not related with dieting.
J Drugs Dermatol. 2016;15(4):491-495.
Mid-Face Volumization With Hyaluronic Acid: Injection Technique and Safety Aspects from a Controlled, Randomized, Double-Blind Clinical Study
Welf Prager MD,a Karla Agsten MD,b Maria Kravtsov MSc,c and Prof. Martina Kerscher MDd| |
BACKGROUND: Injection of hyaluronic acid (HA) volumizing fillers in the malar area is intended for rejuvenation of the mid-face. The choice of products, depth, and technique of injection depends on the desired level of volume enhancement and practitioners’ preferences.
OBJECTIVE: To describe a volumizing injection technique in the scope of a controlled, randomized, double-blind, single-center, split-face clinical study. Materials & Methods: A total of 45 subjects with bilateral symmetrical moderate to severe volume loss in the malar area received a single 2 mL injection of CPM®-26 (Cohesive Polydensified Matrix®) on one side and VYC®-20 (VYCROSS®) on the contralateral side of the face. The same injection technique was applied for both sides of the face. Use of anesthetics, overcorrection, and touch-ups were not permitted. The investigator completed a product satisfaction questionnaire. Adverse events (AE) and injection-site reactions (ISRs) were reported during the study.
RESULTS: The products were placed at the epiperiosteal depth in 88.9% (n=40), at the subdermal depth in 8.9% (n=4) and at both levels in 2.2% (n=1) of subjects. Fanning technique using cannulae was applied in most cases (97.8%, n=44). Results of the investigator satisfaction questionnaire allowed to characterize CPM-26 in comparison to other volumizing gels. Both study products were generally well tolerated. Local reactions were transient and of mild to moderate intensity, with the most frequent ones being redness, pain, and swelling.
CONCLUSION: Adequate injection technique in volumizing treatments is essential to create a natural aesthetic rejuvenation while respecting the safety aspect of the procedures. A 22G blunt cannula used with CPM-26 was preferred due to an easier and a more homogeneous distribution of the product. The investigator also appreciated CPM-26 for its ease of injection, positioning, lifting, and volumizing capacity.
J Drugs Dermatol. 2017;16(4):351-357.
Clinical Evidence for the Role of a Topical Anti-Inflammatory Agent in Comedonal Acne: Findings From a Randomized Study of Dapsone Gel 5% in Combination With Tazarotene Cream 0.1% in Patients With Acne Vulgaris
Emil Tanghetti MD,a Sunil Dhawan MD,b Lawrence Green MD,c Mark Ling MD PhD,d Jeanine Downie MD,e Marguerite A. Germain MD,f J. Scott Kasteler MD,g Leon Kircik MD,h Michael G. Oefelein MD,i Zoe Draelos MDj| |
Background: Acne pathogenesis is multifactorial and includes inflammation. Combining drugs targeting multiple components of
acne pathogenesis is standard practice.
Objective: To assess the safety and efficacy of dapsone gel 5%, an anti-inflammatory agent, in combination with tazarotene cream 0.1% for treatment of acne vulgaris.
Methods: Patients were randomized to receive combination therapy (dapsone gel 5% twice-daily plus tazarotene cream 0.1% daily) or monotherapy (tazarotene cream 0.1% daily). Efficacy and safety data were collected after 1, 2, 4, 8, and 12 weeks of treatment.
Results: Patients in both arms (n=86, dapsone + tazarotene; n=85, tazarotene) showed significant reductions from baseline in inflammatory, noninflammatory and total lesion counts (P<.001 for all). At 12 weeks, patients treated with dapsone plus tazarotene showed a greater reduction from baseline in noninflammatory (comedonal) and total lesion counts than tazarotene-treated patients (noninflammatory, 59.7 percent vs. 46.5 percent, P=.01; total, 63.3% vs. 53.6%, P=.02). The percentage of patients achieving treatment success (an investigator subjective score of 0 [none] or 1 [minimal]) was greater in dapsone plus tazarotene-treated patients (42.2%) than in tazarotene-treated patients (21.8%;P=.01). Both treatments were well tolerated.
Conclusion: Combination therapy with dapsone gel 5% plus tazarotene cream 0.1% was more effective than tazarotene monotherapy for treatment of comedonal acne. The results suggest that anti-inflammatory agents such as dapsone can effectively treat early stages of acne (both comedonal and noncomedonal) when used in combination with a retinoid.
J Drugs Dermatol. 2011;10(7):783-792.
Evaluation of the Safety and Efficacy of a Non-contact Radiofrequency Device for the Improvement in Contour and Circumferential Reduction of the Inner and Outer Thigh
David McDaniel MDa and Petra Samková MDb| |
MATERIALS AND METHODS: A total of 30 female subjects age 32 to 59 (average 42.4) were enrolled in the study. After meeting the inclusion/ exclusion criteria each subject received 4 weekly 30-minute bilateral thigh treatments (1 hour total treatment time). As the primary outcomes, circumferential reduction was measured and clinical before and after photographs were taken for assessment. Safety of the device was assessed by means of reported adverse events.
RESULTS: All 30 subjects completed the entire treatment series and 1 month follow-up visit. The average reduction measured on both thighs was 3.86 cm with statistical significance P< 0.05. There was no significant change in weight for any of the subjects. During the course of the study two adverse events occurred, but were deemed unrelated to the treatment.
CONCLUSIONS: Based on the measurements obtained the device under investigation was considered safe and effective in terms of improved contour and circumferential reduction of inner and outer thighs.
J Drugs Dermatol. 2015;14(12):1422-1424.
Todd E. Schlesinger MD FAADa and Callie Rowland Powell BSN RNb| |
DESIGN and SETTING: Prospective, observational, non-blinded efficacy and tolerability study in an outpatient setting.
PARTICIPANTS: Individuals 18 to 75 years of age with mild to moderate facial rosacea.
MEASUREMENTS: Outcome measures included papules, pustules, erythema, edema, telangiectasia, burning or stinging, dryness and provider global assessment (PGA), which were all measured on a five-point scale. Subjects were assessed at baseline, week 2, week 4, and week 8.
RESULTS: Final data for 14 of 15 subjects are presented. Through visual grading assessments, hyaluronic acid sodium salt cream 0.2% was shown to improve the provider global assessment by 47.5 percent from baseline to week 4. Reductions in papules, erythema, burning or stinging, and dryness were 47, 51.7, 65, and 78.8 percent, respectively at week 4. At week 8, the provider global assessment was improved from baseline in 78.5 percent of subjects.
CONCLUSION: Improvement was noted in measured clinical parameters with use of topical low molecular weight hyaluronic acid. Topical low molecular weight hyaluronic acid is another option that may be considered for the treatment of rosacea in the adult population. Compliance and tolerance were excellent. Consideration should be given to use for individuals with rosacea characterized by an erythematous and/or papular component.
J Drugs Dermatol. 2013;12(6):664-667.
A Comparison of Psoriasis Drug Failure Rates and Reasons for Discontinuation in Biologics vs Conventional Systemic Therapies
Adriane A. Levin BA,a,b Alice B. Gottlieb MD PhD,b,c and Shiu-chung Au MDb| |
DESIGN: Retrospective, cross-sectional.
METHODS: All patient visits coded for psoriasis (ICD-0 696.1) in the clinical practice of 2 dermatologists from January 1 2008 through January 4 2012 were included in this retrospective data analysis. The practice is a comprehensive psoriasis care center in the northeastern United States serving a metropolitan population of over 4 million people. Patients were divided by treatment type: biologic or traditional systemic. Treatment failure was defined as discontinuation of treatment course for any reason. Patient time to failure for each therapy was calculated, as were previous treatments and reasons for treatment discontinuation.
RESULTS: One hundred and fifty-nine patients who underwent 284 courses of treatment were studied. Forty-eight percent of biologics failed in an average of 242 days, compared with 75% of traditional systemics (P<.0001), which failed in an average of 143 days (P<.0001). Infliximab had the longest survival time (292 days), and ustekinumab had the smallest failure rate (39%). Reasons for discontinuation differed significantly between biologics and systemics, with biologics being discontinued more often due to loss of efficacy (P=.0014), and systemics failing significantly more frequently due to adverse events (P<.001). Adverse events were observed most frequently with methotrexate and infliximab, while golimumab had the highest rates of both loss and lack of efficacy.
CONCLUSION: Biologics had longer survival times and lower failure rates than traditional systemics in the treatment of psoriasis. Biologics were more likely to be discontinued due to loss of efficacy, and systemics were more likely to fail due to adverse events.
J Drugs Dermatol. 2014;13(7):848-853.
A Randomized, Investigator-Blinded Comparison of Two Topical Regimens in Fitzpatrick Skin Types III-VI With Moderate to Severe Facial Hyperpigmentation
Monique J. Vanaman Wilson MD,a Isabela T. Jones MD,b Joanna Bolton MD,c Lisa Larsen DO,d Douglas C. Wu MD PhD,e and Mitchel P. Goldman MDe,f| |
Purpose: Though hydroquinone (HQ) remains the gold standard for treatment of hyperpigmentation, concerns about its safety have prompted the development of HQ-free topical skin lightening systems. Objective: To compare the efficacy and tolerability of a new HQ-free system and a popular HQ-based system for the improvement of facial hyperpigmentation and photoaging in darker skin types. Methods: This investigator-blinded trial randomized 30 subjects of Fitzpatrick skin types III to VI with moderate to severe hyperpigmentation to a new 7-product HQ-free system or a 7-product HQ-based system for 12 weeks. At 4, 8, and 12 week follow-up visits, a blinded investigator assessed efficacy and tolerability using standardized scales. Subjects also performed a self-assessment at each visit. Summary: Both the HQ-free and HQ-based systems produced significant improvements in Overall Hyperpigmentation that were sustained through week 12 (P=0.008, 0.0003). The HQ-based system demonstrated better improvement in overall hyperpigmentation at weeks 4, 8, 12 (P=0.01, 0.001, 0.003, respectively). Mottled Pigmentation Area Severity Index (MoPASI) scores improved with both systems (P=0.02, 0.01), with no statistically significant differences between the two treatment groups. Subject-rated hyperpigmentation was not different between groups. Subjects reported significantly more discomfort with the HQ-free system at week 8 (P=0.02); otherwise, measures of irritation were the same between groups. All irritation was described as mild to moderate. At week 12, 100% of subjects in the HQ-free group and 92.3% of subjects in the HQ-based group were satisfied with their outcome. Conclusion: Both a new HQ-free skincare system and a widely-available HQ-based system improved hyperpigmentation in Fitzpatrick skin types III to VI. Though the HQ-based system produced greater improvement in hyperpigmentation when compared to the HQ-free system, there was no difference in MoPASI scores between the treatment groups. Subjects were satisfied with both treatments and reported only mild to moderate irritation using either system.
J Drugs Dermatol. 2017;16(11):1127-1132.
Evaluation of Risk of Major Adverse Cardiovascular Events With Biologic Therapy in Patients With Psoriasis
Robert Bissonnette MD,a Francisco Kerdel MD,b Luigi Naldi MD,c Kim Papp MD,d Claudia Galindo MD,e Wayne Langholff PhD,f K. L. Tang PhD,f Philippe Szapary MD MSCE,f Steven Fakharzadeh MD PhD,e Bhaskar Srivastava MD PhD,e Kavitha Goyal MD,e and Alice B. Gottlieb MD PhDg| |
J Drugs Dermatol. 2017;16 (10):1002-1013.
Aim: Despite a mostly self-limiting course, infantile hemangiomas can cause severe functional and/or cosmetic problems. The aim of this
study was to determine the efficiency of propranolol treatment on infantile hemangiomas.
Methods: Sixty-seven infantile hemangioma patients were included in propranolol protocol in two institutions from 2009 to 2011. Participants included 36 boys and 31 girls. An associate protocol with radiology and pediatric cardiology was constructed for appropriate patient selection. Patients received a dose of 2 mg/kg/day, and all were admitted for the first 24 hours of therapy.
Results: Sixty-seven patients were included in the study. Mean age at the initiation of therapy was 7 months (1 to 24 months), and eleven patients were older than 12 months of age when propranolol was started. All patients showed improvement with varying responses. No side effects were detected during the treatment.
Conclusion: Previously defined treatments for hemangiomas were efficient, yet had a limited usage because of side effects. Propranolol, with a high efficacy (not as total involution but stabilization and regression) and feasibility deserves to be the first line therapy for infantile hemangiomas even after the proliferation phase.
J Drugs Dermatol. 2012;11(7):808-811.
Characterization and Assessment of Nanoencapsulated Sanguinarine Chloride as a Potential Treatment for Melanoma
Jamie Rosen BA,a* Angelo Landriscina BA,a* Brandon L. Adler BA,a Aimee Krauz BA,a Jessica Doerner MS,b
Mahantesh Navati PhD,c Tagai Musaev BA,a Claudia Gravekamp PhD,b Joshua Nosanchuk MD,b,d
and Adam J. Friedman MDa,c
J Drugs Dermatol. 2015;14(5):453-458.
Evaluation of a Low Energy, Low Density, Non-Ablative Fractional 1927nm Wavelength Laser for Facial Skin Resurfacing
Jeremy A. Brauer MD,a,b Hamad Alabdulrazzaq MBChB,a Yoon-Soo Cindy Bae MD,a,b
and Roy G. Geronemus MDa,b
DESIGN: Prospective non-randomized trial.
SETTING: Single center, private practice with a dedicated research department.
PARTICIPANTS: Subjects with clinically diagnosed facial photodamage, melasma, or post inflammatory hyperpigmentation
INTERVENTIONS: Subjects received four to six treatments at 14-day intervals (+/- 3days) with a low energy low density non-ablative fractional 1,927-nm laser (Solta Hayward, CA) with an energy level of 5 mJ, and density coverage of either 5%, 7.5%, or 10%, with a total of up to 8 passes.
MAIN OUTCOME AND MEASURES: Blinded assessment of clinical photos for overall improvement at one and three months post final treatment. Investigator improvement scores, and subject pain and satisfaction scores for overall improvement were recorded as well.
RESULTS: We enrolled 23 subjects, average age 45.0 years (range, 25-64 years), 22 with Fitzpatrick Skin Types I-IV and 1 with Type VI, with facial photodamage, melasma, or post inflammatory hyperpigmentation. Approximately 55% of subjects reported marked to very significant improvement at one and three months post final treatment. Blinded assessment of photography of 20 subjects revealed an average of moderate improvement at one-month follow up and mild to moderate improvement at three months. Average subject pain score was 3.4/10 during treatment.
CONCLUSIONS AND RELEVANCE: Favorable outcomes were demonstrated using the low energy low density, non-ablative fractional 1,927-nm laser in facial resurfacing for photodamage, melasma, and post inflammatory hyperpigmentation. Results were maintained at the 3-month follow up, as demonstrated by investigator and subject assessments, as well as blinded evaluations by three independent dermatologists utilizing photographs obtained from a standardized facial imaging device.
J Drugs Dermatol. 2015;14(11):1262-1267.
Daniel Y. Sugai MD,a Cheryl J. Gustafson MD,a Jacqueline F. De Luca MD,a Scott A. Davis MA,aJoseph L. Jorizzo MD,a Kenneth S. O'Rourke MD,b and Steven R. Feldman MD PhDa,c,d| |
OBJECTIVE: The objectives for this study were to evaluate trends in the medications prescribed for the management of lupus erythematosus (LE) and to assess how treatment varies among different specialists.
METHODS: Outpatient visits for treatment of lupus and its comorbidities were identified in the National Ambulatory Medical Care Survey (NAMCS), a representative survey of visits to physician offices in the United States. Data was evaluated to determine patient demographics, treatments prescribed by each specialty, and comorbidities encountered during the study period of 1993-2010.
RESULTS: From 1993-2004, prednisone was the most frequently prescribed medication; however, prednisone became the second most frequently prescribed medication in 2005-2010, as hydroxychloroquine became the leading medication prescribed for LE. In primary care physicians and other non-dermatology specialists, the most frequently prescribed medications for lupus were prednisone and hydroxychloroquine; whereas, hydroxychloroquine and triamcinolone were the top two medications preferred by dermatologists.
LIMITATIONS: The NAMCS collects cross-sectional data, such that individual patients cannot be followed over time. Hence, it does not provide data regarding the incidence of disease, patient age at the time of diagnosis, change in individual patient’s medication regimens over time, or prognosis related to patient demographics. In addition, it is possible that the physician did not always record nonprescription medication use, such as NSAIDS, since these are typically used first line.
CONCLUSION: First-line treatment of LE changed minimally from 1993 to 2010, with prednisone and hydroxychloroquine serving as the primary medications utilized by most physicians for the management of LE.
J Drugs Dermatol. 2014;13(5):545-552.
Customized Single-agent Therapy Management of Severe Inflammatory Acne: A Randomized, Double-blind, Parallel-group, Controlled Study of a New Treatment - Adapalene 0.3%-Benzoyl Peroxide 2.5% Gel
Jonathan Weiss MD,a Linda Stein Gold MD,b Matthew Leoni MD,c Maria Jose Rueda MD,d Hong Liu Msc,c and Emil Tanghetti MDe| |
OBJECTIVES: To demonstrate superior efficacy of adapalene 0.3%-benzoyl peroxide 2.5% gel (0.3% A/BPO) vs. vehicle, and to assess efficacy of 0.3% A/BPO vs. 0.1% A/BPO in subjects with severe inflammatory acne (Investigator’s Global Assessment [IGA] of 4) in the context of a larger trial in a moderate and severe population.
METHODS: This was a multicenter, randomized, double-blind, parallel-group, 12-week study. Subjects were randomized to receive 0.3% A/BPO, 0.1% A/BPO (benchmark) or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (percentage of subjects rated “clear” or “almost clear,” ≥3-grade IGA improvement), and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms.
RESULTS: In the severe inflammatory acne population, a total of 252 subjects were randomized with 106, 112 and 34 subjects in the 0.3% A/BPO, 0.1% A/BPO and vehicle groups, respectively, reaching a high rate of study completion (88.5%). At week 12, both 0.3% A/BPO and 0.1% A/BPO were superior to vehicle in terms of lesion count reduction. However for success rate, only 0.3% A/BPO achieved significantly greater efficacy over vehicle with a treatment difference of 20.1% (31.9% vs. 11.8%; 95% Confidence Interval (CI): [6.0%, 34.2%], P=.029), whereas 0.1% A/BPO did not (treatment difference vs. vehicle of 8.8%; P=.443). This translates to an 11% difference between active treatments in favor of 0.3% A/BPO. Also, 0.3% A/BPO was safe and well tolerated.
CONCLUSIONS: Availability of this new treatment option should allow clinicians to better customize severe inflammatory acne management, and the high-strength product provides a step-up treatment when needed.
J Drugs Dermatol. 2015;14(12):1427-1435.
Two-Treatment Protocol for Skin Laxity Using 90-Watt Dynamic Monopolar Radiofrequency Device With Real-Time Impedance Intelligence Monitoring
David McDaniel MD,a Robert Weiss MD,b Margaret Weiss MD,b Chris Mazur BS,a and Charmaine Griffin CCRPa| |
OBJECTIVE: The objective was to validate effectiveness of a modified treatment protocol for a unique monopolar radiofrequency device, which has been engineered with greater power and self-monitoring circuitry.
METHODS: Twenty-four female subjects received bilateral monopolar radiofrequency treatments to the mid and lower face from the sub malar region to the submentum. Subjects completed 1 and 3 month follow ups with digital imaging. Skin biopsies (on 4 subjects) and ultrasound measurements (on 12 subjects) were completed.
RESULTS: Assessments demonstrated a reduction in skin laxity of 35%, a reduction in fine lines/wrinkles of 42%, and a reduction in the appearance of global photodamage of 33%. Expert photograding demonstrated 92% of subjects showing at least a mild improvement in skin laxity at three months post treatment. 50MHz ultrasound measurements in 12 subjects showed an increase of 19% in skin density. Histology showed a marked increase in dermal collagen and elastin fibers in two subjects who demonstrated a clinically noticeable reduction in skin laxity and minimal changes in two subjects who demonstrated minimal clinical improvements. There were no significant adverse events reported.
CONCLUSION: This modified radiofrequency device and treatment protocol was well tolerated and produced improvements in the appearance of skin laxity and overall anti-aging effects in the majority of subjects. Objective measurements including ultrasound and histology help explain the clinical outcome.
J Drugs Dermatol. 2014;13(9):1112-1117.
An Over-the-Counter Moisturizer Is as Clinically Effective as, and More Cost-Effective Than, Prescription Barrier Creams in the Treatment of Children With Mild-to-Moderate Atopic Dermatitis: A Randomized, Controlled Trial
Background: Atopic dermatitis (AD) is a prevalent skin disorder with significant cost of treatment. Several prescription device moisturizers have been approved by the FDA to treat AD but are significantly more expensive than well-crafted over-the-counter (OTC) moisturizers. No studies have been performed to compare both the clinical efficacy and cost-efficacy of these prescription devices to OTC moisturizers.
Purpose: The purpose of this study is to compare the clinical efficacy and cost-efficacy of a glycyrrhetinic acid-containing barrier repair cream (BRC-Gly, Atopiclair®), a ceramide-dominant barrier repair cream (BRC-Cer, EpiCeram®) and an OTC petroleum-based skin protectant moisturizer (OTC-Pet, Aquaphor Healing Ointment®) as monotherapy for mild-to-moderate AD in children.
Methods: Thirty-nine patients, age 2-17 years, with mild-to-moderate AD were randomized 1:1:1 to receive one of three treatments—BRC-Gly, BRC-Cer or OTC-Pet—with instructions to apply the treatment three times daily for three weeks. Disease severity and improvement was assessed at baseline and on days 7 and 21.
Results: No statistically significant difference for any efficacy assessment was found between the three groups at each time point. The OTC-Pet was found to be at least 47 times more cost-effective than BRC-Gly or BRC-Cer.
Limitations: The relatively small sample size of 39 subjects was not sufficient to establish OTC-Pet as superior treatment in AD.
Conclusions: OTC-Pet is as effective in treating mild-to-moderate AD as both BRC-Gly and BRC-Cer and is at least 47 times more cost-effective.
Name of registry: II-AF-ATD-Aquaphor, Comparing the Efficacy and Cost-Effectiveness of Aquaphor to Atopiclair and EpiCeram in Children with Mild to Moderate Atopic Dermatitis
Registration Identifier: NCT01093469
J Drugs Dermatol. 2011;10(5):531-537.
Assessment of the Safety and Efficacy of Topical Copper Chlorophyllin in Women With Photodamaged Facial Skin
Monya L. Sigler PhD, and Thomas J. Stephens PhD| |
OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied sodium copper chlorophyllin complex in women with mild-moderate fine lines and wrinkles in the periocular areas and facial solar lentigenes over a course of 8 weeks.
METHODS: Subjects were supplied with the test product, a topical gel containing chlorophyllin complex salts (0.066%), with directions to apply a pea-sized amount to the periocular areas, cheeks and nose every morning and evening. Clinical assessments were performed at screening/baseline and at week 8. Standardized digital photographs were taken and self-assessment questionnaires were conducted.
RESULTS: Ten subjects completed the 8-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 8. The study product was well tolerated. Subject questionnaires showed the test product was highly rated.
CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown to be clinically effective and well tolerated for the treatment of mild-moderate photodamage and solar lentigenes when used for 8 weeks.
J Drugs Dermatol. 2015;14(4):401-404.
Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies
Linda Stein Gold MD,a Mark Lebwohl MD,b Alan Menter MD,c John Villumsen MSc,d Monika Rosen PhD,d and John Koo MDe| |
METHODS: Patients aged ≥18 years with mild–severe psoriasis were enrolled into three Phase II/III studies (nCT01536886, nCT01536938, nCT01866163); each study evaluated Cal/BD aerosol foam versus different comparators. Endpoints included: proportion of patients clear/almost clear with ≥2-step improvement in physician's global assessment of disease severity (‘treatment success’); modified (excluding head) psoriasis area and severity index (mPASI); proportion of patients with ≥75% reduction in mPASI (PASI75); change in itch (according to visual analog scale [VAS]).
RESULTS: 1104 patients were included in the pooled analysis: Cal/BD aerosol foam (n=564), Cal/BD ointment (n=135), BD aerosol foam (n=101), Cal aerosol foam (n=101), aerosol foam vehicle (n=152), ointment vehicle (n=51). At week 4, 51% of Cal/BD aerosol foam patients achieved treatment success, a higher proportion than in all other groups (Cal/BD ointment, 43%; BD aerosol foam, 31%; Cal aerosol foam, 15%; aerosol foam vehicle, 5%; ointment vehicle, 8%). Greater percentage mean decrease in mPASI with Cal/BD aerosol foam was noted versus other treatments at week 4 (72% vs 63%, 53%, 43%, 32%, and 33%, respectively); week 4 PASI75 rate was also greater (51% vs 41%, 34%, 18%, 7%, and 10%, respectively). Cal/BD aerosol foam was efficacious irrespective of baseline disease severity and on all body areas assessed (arms, legs, trunk). Cal/BD aerosol foam alleviated itch as early as week 1 (change in itch VAS: –30 mm), maintained to week 4 (change in itch VAS: –41 mm).
CONCLUSIONS: Cal/BD aerosol foam was significantly more effective than Cal/BD ointment and the individual active ingredients for treating psoriasis vulgaris, resulting in greater and faster reduction in disease severity and rapid, effective relief of itch.
J Drugs Dermatol. 2016;15(8):951-957.
In-Vivo Histological Analysis of a Fractional CO2 Laser System Intended for Treatment of Soft Tissue
Elisabeth Hurliman MD,a Brian Zelickson MD,b Jeffrey Kenkel MDc| |
BACKGROUND: Fractional ablative lasers have been shown to be safe and effective for improving wrinkles, scars, skin texture, and dyspigmentation. However, the exact effects of this technology in vivo on epidermal and dermal skin constituents have not been delineated. This study evaluated the in vivo histological effects over time of treatment with a fractional ablative CO2 system, using different treatment parameters. MATERIALS AND METHODS: Healthy adult volunteers were enrolled in this multicenter clinical study. Study participants, previously scheduled for abdominoplasty, received fractional CO2 laser treatment on the abdomen at a predetermined time prior to surgery. Biopsies were taken at baseline and after CO2 treatment. Morphological and morphometric analyses were performed in the ablated and coagulated tissue areas. RESULTS: Nine healthy adult volunteers were treated. Histologic evaluation showed 800-900 micron diameter zones of ablation and coagulation confined to the upper most layer of the skin in the mode with the greatest fractional skin coverage using Light Mode 30 - 50% (spot diameter of 150 microns, 30-60 millijoules fluence), while ablation to levels of up to 900 microns in depth using the Deep Mode (spot diameter 150 microns, 50-80 millijoules). Healing times of treated tissue varied from 1-day post-treatment with the Light Mode, and up to 10 days post-treatment with the Deep Mode. No remnants of ablation or coagulation were seen after 30 days post CO2 treatment with either mode. There were no adverse events associated with treatments. CONCLUSION: Treatment of the skin using the fractional CO2 device leads to skin resurfacing via ablation and coagulation of the treated area at a depth proportional to the delivered energy. The higher the energy used, the greater the degree of ablation and coagulation in tissue, which can lead to a greater tissue response in terms of fibroblast activity, collagen remodeling, and new collagen formation.
J Drugs Dermatol. 2017;16(11):1085-1090.
Methods: This study was conducted to assess the effect of systemic isotretinoin on the serum level of folic acid. Sixty-one patients, including 38 women and 23 men (mean age 23.6 ± 6 years) with severe or moderate acne that was resistant to conventional treatments, were supplemented with 0.5 mg/kg/d of oral isotretinoin for 30 days. They were instructed not to use any other drugs having an effect on the folic acid level nor change their diet. The serum levels of folic acid were measured at the baseline and at the end of the treatment period. Statistical analyses were carried out using the paired t test.
Results: Mean levels of folic acid were 26.75 ± 9.42 nmol/L at baseline, and and 23.6 ± 8.42 nmol/L after 30 days of isotretinoin supplementation. This showed a significant decrease in the serum level of folic acid (P=.008).
Conclusion: Given the significant decrease in the serum level of folic acid following a 30-day use of oral isotretinoin in acne patients, and considering the important role of folic acid in metabolic functions, we recommend further studies to assess the effect of longer periods of isotretinoin treatment, in addition to studies including other relevant factors in folic acid metabolism (e.g., serum homocysteine levels). Moreover, folic acid supplementation in acne patients using isotretinoin is recommended.
J Drugs Dermatol. 2012;11(9):e23-e24.
Effect of Retinoid Pretreatment on Outcomes of Patients Treated by Photodynamic Therapy for Actinic Keratosis of the Hand and Forearm
Barry I. Galitzer MD| |
Background/Objective: Photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) has been shown to be useful in both spot and field treatments of actinic keratoses (AK). This study evaluates the safety and efficacy of pretreatment of AK lesions on the dorsal hands and forearms with tazarotene gel (0.1%) twice a day for one week before broad-area ALA PDT.
Methods: Ten subjects aged 75.4 ± 11.6 years (mean ± SD) with at least four AK lesions on their dorsal forearm or hand were randomized so that one dorsal hand or forearm was pretreated with tazarotene gel (0.1%) twice daily for one week before ALA PDT with blue light. The other hand or forearm (control) was not pretreated. After seven days, ALA was applied to both sides and incubated 60 minutes before irradiation with blue light. ALA was applied first only to the AK lesions and then to the entire treatment area (defined as the extensor surface of the hand or forearm between the elbow and the base of the fingers) before 60-minute incubation. The ALA area on the control side was occluded during the 60-minute incubation. Efficacy and adverse effects were evaluated within 48 hours and eight weeks later.
Results: For both the pretreated and control group, lesion counts of the target areas decreased significantly from baseline to eight weeks after ALA PDT. Reduction percentages of the target area, however, did not differ significantly between the two groups. When reduction percentages of the entire treatment area for both groups were compared the difference between the two groups was of borderline significance (P=0.0547). When the entire treatment area was analyzed, lesion counts of the tazarotene group differed significantly from baseline at eight weeks (P=0.0002), but this was not the case with the control group (P=0.0365). Adverse events were limited to those expected after ALA PDT. Erythema was significantly more severe (P=0.0029) in the pretreated arm five minutes after ALA PDT.
Conclusion: Pretreatment of AK lesions on the dorsal hand and forearm with tazarotene gel (0.1%) may enhance the therapeutic effect of ALA PDT without serious side effects.
J Drugs Dermatol. 2011;10(10):1124-1132.