Search Results for "Microdermabrasion and Chemical Peels"
Diane S. Berson MD FAAD, Joel L. Cohen MD FAAD, Marta I. Rendon MD, Wendy E. Roberts MD,Isaac Starker MD FACS, Beatrice Wang MD FRCPC FAAD| |
Efficacy of Microdermabrasion Preceding ALA Application in Reducing the Incubation Time of ALA in Laser PDT
Bruce E. Katz MD, Sarah Truong MD, Diane C. Maiwald MD, Kathryn E. Frew MD, Dean George 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.
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.
Assessment of a Superficial Chemical Peel Combined With a Multimodal, Hydroquinone-Free Skin Brightener Using In Vivo Reflectance Confocal Microscopy
Lisa T. Goberdhan BA, Lora Colvan BA, Elizabeth T. Makino BS CCRA MBA, Caroline Aguilar RN BSN, and Rahul C. Mehta PhD| |
J Drugs Dermatol. 2013;12(3 suppl 1):s38-s41.
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.
Rachel Seidel BAa,c and Ronald Moy MD FAADb,c| |
OBJECTIVE: The aim of this study was to evaluate the ability of the CO2 facial to oxygenate the skin.
METHODS AND MATERIALS: Twelve patients were enrolled in this split-face study. They were treated one week apart with a CO2 facial on one side of the face and particle-free microdermabrasion on the other. Measurements of transcutaneous oxygen tension (tcPO2) were recorded at baseline and after each treatment. Statistical significance was assessed by comparing the average tcPO2 difference in mmHg following microdermabrasion and after a carbon dioxide facial using a 1-tailed paired t-test (α = 0.05).
RESULTS: The average increase in tcPO2 after CO2 facial treatment was statistically significantly greater (p = .0252) than after microdermabrasion.
CONCLUSION: Carbon dioxide facials improve skin oxygenation immediately following treatment, attributable to the generation of an artificial Bohr effect.
J Drugs Dermatol. 2015;14(9):976-980.
Lucija Kroepfl MBChBa and Jason J. Emer MDb| |
Michael Kockaert, MD and Martino Neumann, MD, PhD| |
J Drugs Dermatol. 2012;11(9):e10-e17.
J Drugs Dermatol. 2012;11(9):e5-e9.
Douglas E. Kligman MD PhDa and Zoe D. Draelos MDb| |
OBJECTIVE: The objective of this research was to compare the efficacy for ameliorating photodamage of topical tretinoin (0.25%) and retinol (0.25%) to baseline and with each other when applied after a 30% salicylic acid peel on human facial skin.
METHODS: Twenty female subjects received a full face 30% SA peel followed by the overnight application of tretinoin to a 1 randomized half-face and retinol to the opposite side (split-face study). The identical procedure was repeated at week 2. Double-blinded subject and investigator assessments of the results were captured at weeks 2 and 4.
RESULTS: By investigator evaluation, both peeling regimens were effective in improving photodamage parameters compared to baseline. (ATRA P-values at week 4 were: P=.00008 texture, P=.00013 roughness, P=.00221 pores, P=.00098 dryness, P=.02770 erythema, and P=.00008 overall appearance. Retinol P-values at week 4 were: P=.00019 texture, P=.00053 roughness, P=.00221 pores, P=.00147 dryness, P=.02770 erythema, and P=.0043 overall appearance.) By subject self-assessment compared with baseline, both tretinoin and retinol were effective in improving overall appearance (ATRA P=.0229 and retinol P=.0190). By investigator evaluation comparing tretinoin with retinol, tretinoin was slightly better than retinol at week 4 in improving texture P=.00506, roughness P=.01171, and overall appearance P=.00506. By subject self-assessment comparing tretinoin with retinol, there was no difference in overall appearance (ATRA P=.2367 and retinol P=.3613).
CONCLUSION: Either topical tretinoin (0.25%) or retinol (0.25%) can be used safely and effectively when applied in office immediately after SA peeling to ameliorate signs of photoaging.
J Drugs Dermatol. 2016;15(4):442-450.
Adam Rees MD, Quyn Sherrod MD, Lorraine Young MD| |
J Drugs Dermatol. 2011;10(4):414-417.
J Drugs Dermatol. 2011;10(2):125-132
The Treatment of Melasma With Topical Creams Alone, CO2 Fractional AblativeResurfacing Alone, or a Combination of the Two: A Comparative Study
Mario A. Trelles MD PhD, Mariano Velez MD, Michael H. Gold MD| |
Patients and Methods: Thirty females with melasma, mean age of 38 years, skin types II–IV, were allocated to three groups: group A received treatment with Kligman’s formula maintenance topical cream program; group B, CO2 fractional resurfacing using high power, fixed pulse width and low frequency; and group C, both laser and maintenance topical cream treatment. Subjective patient and clinician assessments based on melasma area severity index (MASI) scores were made at baseline, one, two, six and 12 months, and the satisfaction index (SI) and overall efficacy calculated.
Results: All patients completed the study. The SI and overall efficacy in groups A, B and C were 100% at one month in all groups but progressively decreased in further assessments except for group C in which better scores were maintained throughout. MASI scores for group C were statistically significantly improved compared to A and B at six and 12 months (P<0.001 for both).
Conclusion: The fractional CO2 laser and topical cream regimen produced good, well-maintained results in melasma treatment compared with the monotherapy groups.
Improvement of Atrophic Acne Scars in Skin of Color Using Topical Synthetic Epidermal Growth Factor (EGF) Serum: A Pilot Study
Marie Alexia Stoddard BS,a Jennifer Herrmann MD,b,c,d Lauren Moy MD,e and Ronald Moy MDb,f| |
BACKGROUND: Atrophic scarring in skin of color is a common, permanent, and distressing result of uncontrolled acne vulgaris. Ablative lasers and chemical peels are frequently used to improve the appearance of atrophic scars, primarily through the stimulation of collagen and elastin; however, these treatment modalities are associated with risks, such as dyspigmentation and hypertrophic scarring, especially in patients with darker skin.
OBJECTIVE: We evaluated the efficacy of topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars in skin of color.
METHODS: A single-center clinical trial was performed on twelve healthy men and women (average age 32.5) with Fitzpatrick Type IV-V skin and evidence of facial grade II-IV atrophic acne scars. Subjects applied topical EGF serum to the full-face twice daily for 12 weeks. Scar improvement was investigated at each visit using an Investigator Global Assessment (IGA), a Goodman grade, clinical photography, and patient self-assessment.
RESULTS: Eleven subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 3.36 (SEM = 0.15) to 2.18 (SEM = 0.33). Mean Goodman grade was reduced from 2.73 (SEM = 0.19) to 2.55 (SEM = 0.21). Of the eleven pairs of before and after photographs, nine were correctly chosen as the post-treatment image by a blind investigator. On self-assessment, 81% reported a “good” to “excellent” improvement in their scars compared to baseline (P = 0.004).
CONCLUSION: Topical EGF may improve the appearance of atrophic acne scars in skin of color. Additional, larger studies should be conducted to better characterize improvement.
J Drugs Dermatol. 2017;16(4):322-326.
Savita Chaudhary MD Fellow ISDa and Surabhi Dayal MDb| |
OBJECTIVE: To assess the efficacy of combination of topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling in the treatment of melasma in Indian patients.
METHODS: Forty Indian patients of moderate to severe epidermal variety melasma were divided into two groups of 20 each. One Group i.e. peel group received topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling and other group i.e. control group received topical regimen (2% hydroquinone, 1% hydrocortisone, 0.05% tretinoin).
RESULTS: There was an overall decrease in MASI from baseline in 24 weeks of therapy in both the groups (P value < 0.05). The group receiving the glycolic acid peel with topical regimen showed early and greater improvement than the group which was receiving topical regimen only.
CONCLUSION: This study concluded that combining topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling significantly enhances the therapeutic efficacy of glycolic acid peeling. The combination of glycolic acid peeling with the topical regimen is a highly effective, safe and promising therapeutic option in treatment of melasma.
J Drugs Dermatol. 2013;12(10):1149-1153.
David L. Chen MDa and Joel L. Cohen MDb| |
Jacob Levitt, MD, Terry Feldman, MD; Ildiko Riss, MD and On-Tai Leung, MD| |
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.
Michael J. Fellner MD FAADa and Nicholas Yohe BSb| |
J Drugs Dermatol. 2013;12(10):1168-1169.
J Drugs Dermatol. 2011;10(12):1370-1375.
Joseph F. Fowler Jr. MD FAAD| |
J Drugs Dermatol. 2014;13(10):1180-1183.
James M. Swinehart MD| |
J Drugs Dermatol. 2012;11(10):1166-1173.
W.Walsh Thomas MDa and Jason D. Bloom MDb| |
Rapid Treatment of Subungual Onychomycosis Using Controlled Micro Nail Penetration and Terbinafine Solution
Ivan Bristow PhD,a Robert Baran MD,b and Michelle Score BSc (Hons)c| |
J Drugs Dermatol. 2016;15(8):974-978.
Antonio Rusciani MD, Angela Motta MD, Luigi Rusciani MD, Carmine Alfano MD| |
Skin Barrier Health: Regulation and Repair of the Stratum Corneum and the Role of Over-the-Counter Skin Care
Thomas Lee MD and Adam Friedman MD| |
J Drugs Dermatol. 2016;15(9):1047-1051.
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s29-s31.
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| |
Ellen S. Kurtz PhD, Warren Wallo| |
Deborah S. Sarnoff MD FAAD FACPa and Robert H. Gotkin MD FACSb| |
J Drugs Dermatol. 2015;14(5):472-477.
Jay P. Tiesman PhD| |
Jennifer Hayes BAa and John Koo MDb| |
The potential relationship between systemic retinoids used in dermatology and affective disorders is controversial. Acitretin, which is widely used in the treatment of psoriasis is part of this controversy secondary to its chemical relation to isotretinoin, a drug which has been associated with a large number of anecdotal case reports of depression and suicidal ideation. Moreover, an FDA package insert precaution regarding acitretin's association with depression and suicide has elevated the level of concern for patient safety. The objective of this article is to review the evidence in the literature regarding acitretin's association with affective disorders. After 12 years of worldwide use only two cases involving acitretin have been reported in the literature. In addition, despite many anecdotal cases involving isotretinoin, there have been no clinical studies that have proven a causal relationship between isotretinoin and depression or suicidal ideation. For acitretin there have been no systematic clinical studies that examine such a relationship. Moreover, it is notable that the FDA precaution regarding depression and suicide on the package insert of acitretin predates the publication of the aforementioned two cases. This suggests that a relationship between acitretin and affective disorders is a class labeling rather than a scientifically proven association.
J Drugs Dermatol. 2011;10(4):409-412.
Sabrina Guillen Fabi MD,a Joel L. Cohen MD,b Jennifer D. Peterson MD,c Monika G. Kiripolsky MD,d and Mitchel P. Goldman MDa,e| |
OBJECTIVE: Evaluate the safety and efficacy of a topical antiphotoaging product containing secretions of the snail Cryptomphalus aspersa (SCA) for the improvement of facial rhytides.
MATERIALS and METHODS: This was a 2-center, double-blind, randomized, 14-week study in which 25 patients with moderate to severe facial photodamage were treated with an emulsion (with 8% SCA) and liquid serum (with 40% SCA) on one side of the face and placebo on the contralateral side for 12 weeks. Silicone skin impressions of periocular rhytides were performed at baseline and after 12 weeks of treatment. Patient and physician assessments were also performed at 8, 12, and 14 weeks.
RESULTS: Periocular rhytides on the active ingredient side showed significant improvement after 12 weeks (P=.03) and improved texture to a greater degree than placebo at 8 and 12 weeks, as well as 2 weeks after discontinuing the product (14 weeks).
CONCLUSION: Daily application of topical products containing SCA proved effective and well tolerated for improvement in coarse periocular rhytides and fine facial rhytides. Subjects noted a significant degree of improvement in fines lines at the 8-week time point on the SCA-treated side (P≤.05) but did not report a significant difference in the quality of their skin.
J Drugs Dermatol. 2013;12(4):453-457.
Tian-Hua Xu MD,a John ZS Chen MD,b Yuan-Hong Li MD,a Yan Wu MD,a Yao-Jia Luo MD,a Xing-Hua Gao MD,a Hong-Duo Chen MDa| |
Background: L−ascorbic acid has been widely used to treat photo-aged skin. However, its aqueous formula is prone to oxidation. Therefore, a new formula that contains 23.8% L−ascorbic acid and a chemical penetration enhancer was developed.
Objective: Observe the efficacy and safety of topical 23.8% L−ascorbic acid serum on photo-aged skin.
Methods: Twenty Chinese women with photo-aged skin were enrolled in this split-face study. They were treated with topical L−ascorbic acid serum with iontophoresis on one side of the face once a day for 2 weeks; the other side of the face was spared treatment through participants´ self-control. Changes in photo-aged skin were evaluated using a global evaluation, an overall self-assessment, a spectrophotometer, the phase-shift rapid in vivo measurement of skin (PRIMOS) 3D, and a corneometer.
Results: Sixteen of 20 patients (80%) experienced a score decrease of 2 or 3 grades, according to the dermatologist. Fifteen patients (75%) rated their overall satisfaction as excellent or good. Dyspigmentation, surface roughness, and fine lines on the treated side improved significantly.
Conclusion: Topical 23.8% L−ascorbic acid serum is effective for the treatment of photo-aged skin and does not cause any obvious side effects.
J Drugs Dermatol.2012;11(1):51-56.
Methods: Searches were performed in Medline and EMBASE. Extensive bibliographical research was performed in order to identify additional relevant data sets using Web of Science. Results were screened for inclusion of more than one anatomical site, the use of validated methods, and the use of human subjects.
Results: We identified eight relevant studies, from which we present data.
Conclusion: Determining regional variations in PA is a complex yet critically important task. Current data sets are scarce and inadequate for drawing complete conclusions, but the data seem to suggest increased PA in the forehead and genital skin compared with other anatomical regions. It is our hope that, with the advent of new technologies, an anatomical PA map will begin to emerge from the data. Such descriptive understanding will guide investigation into the mechanisms involved in determining anatomical site differences in PA.
J Drugs Dermatol. 2012;11(10):e48-e51.
Optimizing Topical Antifungal Therapy for Superficial Cutaneous Fungal Infections: Focus on Topical Naftifine for Cutaneous Dermatophytosis
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
A variety of topical antifungal agents are available for the treatment of SCFIs, and they encompass a few major chemical classes: the polyenes (ie, nystatin), imidazoles (ie, ketoconazole, econazole, oxiconazole, etc), allylamines (ie, naftifine, terbinafine), benzylamines (ie, butenafine), and hydroxypyridones (ie, ciclopirox). The 2 major classes that represent the majority of available topical antifungal agents are the azoles and the allylamines. Overall, the allylamines are superior to the azoles in activity against dermatophytes, although both are clinically effective. The reverse is true against yeasts such as Candida spp and Malassezia spp, although topical allylamines have proven to be efficacious in some cases of tinea versicolor and cutaneous candidiasis.
Naftifine, a topical allylamine, is fungicidal in vitro against a wide spectrum of dermatophyte fungi and has been shown to be highly effective against a variety of cutaneous dermatophyte infections. Rapid onset of clinical activity and favorable data on sustained clearance of infection have been documented with naftifine. The more recent addition of naftifine 2% cream has expanded the armamentarium, with data supporting a clinically relevant therapeutic reservoir effect after completion of therapy.
J Drugs Dermatol. 2013;12(suppl 11):s165-s171.
Kosta Y. Mumcuoglu PhD, Stephen C. Barker PhD, Ian F. Burgess MSc, Catherine Combescot-Lang PhD, Robert C. Dalgleish PhD, Kim S. Larsen PhD, Jacqueline Miller PhD, Richard J. Roberts MB BS DCH MPH, Aysegul Taylan-Ozkan MD PhD| |
James R. Schwartz PhD| |
J Drugs Dermatol. 2016;15(2):140-144.
Wendy E. Roberts MD| |
J Drugs Dermatol. 2014;13(4):472-482.
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.
Tapan Patel MBBS MRCP,a Oren Tevet MScb| |
This study evaluated the clinical efficacy and safety of pneumatic injections of Hyaluronic Acid in the treatment of acne scars.
Two patients (Fitzpatrick skin type IV-V) with acne scars received two sessions of pneumatic, needleless injections of crosslinked hyaluronic acid (HA) at 4-week intervals. The treatment response was assessed by comparing pre‐ and 3‐month posttreatment clinical photography.
The patients’ acne scar grade improved from 2 to 1 in the first case, and 3 to 2 in the second case, based on independent physician assessment. Patient degree of satisfaction was similar to the physicians' assessment. No significant adverse events were noted. We conclude that pneumatic injection technology to deliver HA to the tissue is an effective and safe method for improving acne scars, even in patients with dark complexion.
J Drugs Dermatol. 2015;14(1):74-76.
Combined Topical Delivery and Dermalinfusion of Decapeptide-12 Accelerates Resolution of Post-Inflammatory Hyperpigmentation in Skin of Color
Ashish Bhatia MD,a Jeffrey TS Hsu MD,b and Basil M. Hantash MD PhDc| |
Deborah S. Sarnoff MD FAAD FACP| |
Resident Rounds: Part I - Program Spotlight: New York Medical College Dermatology Residency Program, New York, NY
Nikoo Cheraghi MD and Bijan Safai MD| |
Candace Thornton Spann MD| |
J Drugs Dermatol. 2011;10(6):654-657.
Comparison Between 1% Tretinoin Peeling Versus 70% Glycolic Acid Peeling in the Treatment of Female Patients With Melasma
Gita Faghihi MD,a,b Anahita Shahingohar MD,a Amir Hossein Siadat MDa,b| |
Objective: The main purpose was to compare the efficiency and complications of GA 70% with Tretinoin 1% peeling.
Methods: A randomized, double-blinded clinical trial performed on 63 female patients with bilateral melasma. One facial side was treated by drug A (GA 70%) and the opposite side by agent B (Tretinoin 1%) peeling for four sessions with 2-week intervals. Descending changes in Melasma Area and Severity Index (MASI) scores, patients' discomfort and untoward complications following peeling all were evaluated and compared during the research period.
Results: The efficiency of Tretinoin 1% peelings in declining the MASI score (treatment of melasma) was similar to GA 70%, as well as the rare unwanted complications of them. However, the patients' discomfort following procedures as expressed by their own, was significantly lower with Tretinoin 1% compared to GA 70% peeling. The cases' satisfaction with the intervention was statistically similar to each other. Furthermore, we experienced almost the equal times of beginning the therapeutic responses in both groups.
J Drugs Dermatol. 2011;10(12):1439-1442.
Heather Kiraly Orkwis DO and Daniel M. Stewart DO| |
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.
Suzanne Bruce MD,a Jwala Karnik MD,b Laurence Dryer PhD,c and David Burkholder PhDd| |
METHODS: Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a 5-point scale. Subjects’ self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to each study visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
RESULTS: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects’ self-assessments were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly) with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events were recorded during the study.
CONCLUSIONS: Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years as measured by both investigator assessments and subjects’ self-assessments.
J Drugs Dermatol. 2014;13(9):1074-1081.
Efficacy of a Novel Rosacea Treatment System: An Investigator-Blind, Randomized, Parallel-Group Study
James J. Leyden MD| |
Introduction: A rosacea treatment system (cleanser, metronidazole 0.75% gel, hydrating complexion corrector, and sunscreen SPF30) has been developed to treat rosacea.
Methods: Thirty women with mild or moderate erythema of rosacea on their facial cheeks were randomly assigned to use one of the following for 28 days: the rosacea treatment system (RTS); RTS minus metronidazole (RTS-M); or metronidazole 0.75% gel plus standard skin care (standard cleanser and standard moisturizer/sunscreen) (M+SSC).
Results: At day 28, global improvement was evident in 90 percent of patients using RTS, 60 percent using RTS-M, and 67 percent using M+SSC. Erythema was significantly lower with RTS from day 14 onward, and unchanged with M+SSC. The proportion of patients reporting their skin was easily irritated at least sometimes was 40 percent with RTS, 70 percent with RTS-M, and 89 percent with M+SSC.
Conclusion: The rosacea treatment system may offer superior efficacy and tolerability to metronidazole plus the standard skin care used in this study.
J Drugs Dermatol. 2011;10(10):1179-1185.
Oge C. Onwudiwe MD,a Ellen S. Marmur MD,b and Joel L. Cohen MDc| |
J Drugs Dermatol. 2013;12(2):199-205.
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.
Lauren Meshkov Bonati MD,a Gorana Kuka Epstein MD,b and Tamara Lazic Strugar MDa| |
INTRODUCTION: Microneedling procedures are growing in popularity for a wide variety of skin conditions. This paper comprehensively reviews the medical literature regarding skin needling efficacy and safety in all skin types and in multiple dermatologic conditions.
METHODS: A PubMed literature search was conducted in all languages without restriction and bibliographies of relevant articles reviewed. Search terms included: “microneedling,” “percutaneous collagen induction,” “needling,” “skin needling,” and “dermaroller.”
RESULTS: Microneedling is most commonly used for acne scars and cosmetic rejuvenation, however, treatment benefit has also been seen in varicella scars, burn scars, keloids, acne, alopecia, and periorbital melanosis, and has improved flap and graft survival, and enhanced transdermal delivery of topical products. Side effects were mild and self-limited, with few reports of post-inflammatory hyperpigmentation, and isolated reports of tram tracking, facial allergic granuloma, and systemic hypersensitivity.
DISCUSS: Microneedling represents a safe, cost-effective, and efficacious treatment option for a variety of dermatologic conditions in all skin types. More double-blinded, randomized, controlled trials are required to make more definitive conclusions.
J Drugs Dermatol. 2017;16(4):308-314.
Evaluation of a Prescription Strength 4% Hydroquinone/10% L-Ascorbic Acid Treatment System for Normal to Oily Skin
Suzanne Bruce MDa and JoAnne Watson DPMb| |
Methods: Patients with minimal or mild facial photodamage and hyperpigmentation, and normal to oily facial skin, used the treatment system for 12 weeks.
Results: Of 34 females enrolled, 30 completed. Median scores for the overall integrated assessment of photodamage, overall intensity of pigmentation, fine lines and wrinkles, tactile roughness, and laxity were significantly improved at week 12 compared with baseline. Furthermore, ≥90 percent of patients considered their skin was smoother, softer, more evenly toned, and more radiant, and 100 percent were satisfied with the overall appearance of their skin.
Conclusion: The treatment system can help to ameliorate early signs of photodamage in normal to oily skin.
J Drugs Dermatol. 2011;10(12):1455-1461.
Background: Upper lip wrinkling is a common complaint of patients seeking perioral rejuvenation. Lately, manual dermabrasion has
become more popular due to its safety, minimal cost, and favorable results. In several hospitals, the ability to efficiently ste rilize
sand paper has been questioned.
Methods: Between 2007 and 2010, 29 patients underwent manual dermabrasion of the skin of the upper lip using an electric cautery scratch pad during their surgeries.
Results: The average patient was aged 60.2 years. The average healing period was 5.8 days. Patient satisfaction from the procedure ranged from very good to excellent. No serious or long lasting complications have been encountered during our follow-up period.
J Drugs Dermatol.2012;11(5):649-652.
Maritza Perez MD, Janiene Luke MD, Anthony Rossi MD| |
Melasma is an acquired skin condition characterized by irregular brown or hyperpigmented patches typically located on the forehead, cheeks, nose, chin and upper lip. The pathogenesis of melasma is not completely understood, but is thought to be influenced by genetics, UV exposure, thyroid dysfunction and hormonal influences from either pregnancy or hormonal therapeutic medications. Peoples of Latin descent comprise a vast array of skin colors and skin phototypes. Similarly, disorders of pigmentation, particularly melasma, occur more frequently in people of Latin descent when compared to the general population. Melasma can be particularly distressing to patients and has been shown to impact a patient's quality of life in several studies. These factors can raise significant quality of life issues and therefore treatment is not only significant for improving patient clinical outcomes, but is crucial in improving important psychological and emotional aspects of patients' overall well being. This article provides a stepwise approach to the treatment of melasma based on current literature recommendations.
J Drugs Dermatol. 2011;10(5):517-523.
Lissy Hu BA,a Christina Alexander BA,b Nicole F. Velez MD,c F. Clarissa Yang MD,c
Alvaro Laga Canales MD MMSc,c,d Stephanie Liu MD,c and Ruth Ann Vleugels MD MPHc,
J Drugs Dermatol. 2015;14(6):628-630.
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.
Eric S. Schweiger MDa,b and Lauren Sundick RPA-Ca| |
OBJECTIVE: To evaluate the safety and efficacy of a focal approach to fractional CO2 laser treatment for acne scars, coined “Focal Acne Scar Treatment” or “FAST”
PATIENTS and METHODS: This retrospective case series was conducted at Schweiger Dermatology, in New York, NY, with patients treated from November 2011 through May 2012. Overall, six patients (ages 18 to 48) were treated with the fractional CO2 laser resurfacing, using a so called “FAST” technique treating only the acne scars and leaving normal skin untreated. Evaluation was based on physician and patient assessment of improvement at one week and four weeks post-treatment.
RESULTS: All six patients treated with the Focal Acne Scar Treatment technique of fractional CO2 laser resurfacing had significant improvement post treatment ranging from 40% to 70% as estimated by the treating dermatologist and patient at four weeks post treatment. Patient satisfaction was high following FAST method. Temporary post-inflammatory hyperpigmentation was seen in two patients but resolved after a single 1550 nm Erbium Glass fractional laser treatment.
CONCLUSION: The Focal Acne Scar Treatment technique is an effective method of improving the appearance of atrophic acne scars. Higher energy and density levels can be used when utilizing this technique, resulting in improved outcomes when compared with whole face fractional CO2 laser resurfacing. Healing is improved and faster with this technique and no increased incidence of permanent adverse events were found. More studies are needed to further evaluate this new technique.
J Drugs Dermatol. 2013;12(10):1163-1167.
Mona S. Foad MD and Erin Winters BA| |
J Drugs Dermatol. 2013;12(3 suppl 1):s42-s44.
Heather Ciliberto MD,a Arta Farshidi MD,b David Berk MD,b and Susan Bayliss MDa| |
OBJECTIVE: Pilot study to determine if photopneumatic therapy (PPx) can improve the erythema and skin texture in KP.
METHODS: Ten patients with KP were treated with one session of PPx on the upper arm and then evaluated one month later for treatment efficacy.
RESULTS: Average investigator-assessed improvement was 27% in erythema and 56% in skin texture roughness. Average patient self-reported improvement was 52% in erythema and 53% in skin texture. The mean satisfaction score was 6.3 on a scale of 1 to 10 (median 7.5) and 8 out of 10 participants reported they would choose to receive PPx for their KP again in the future.
LIMITATIONS: Small number of patients, short follow-up period, and lack of blinding of the examiner and the patients making recall bias possible.
CONCLUSIONS: One treatment of PPx improved both the erythema and redness associated with KP over at least a one month period.
J Drugs Dermatol. 2013;12(7):804-806.
A Firming Neck Cream Containing N-Acetyl Glucosamine Significantly Improves Signs of Aging on the Challenging Neck and Décolletage
Joel Schlessinger,a MD, Barbara Green RPh MS,b Brenda L. Edison BA,b Lynn Murphy MA,b and Yamini Sabherwal PhDb| |
OBJECTIVE: A clinical study was conducted to evaluate the efficacy and safety of the antiaging neck/décolletage cream over a 16-week treatment period.
METHOD: Caucasian women with moderate texture (including wrinkles, fine lines, laxity, and/or crepiness) on the neck and hyperpigmentation on the décolletage used the test cream for 16 weeks. At weeks 0, 8, 12 and 16, the dermatologist investigator graded neck texture, décolletage texture and décolletage pigmentation using a 0-5 scale, and irritation/tolerability using a 0-4 scale. Subjects were photographed and provided self-assessment of their aging parameters as well as product tolerability. Chromameter measurements were collected in triplicate on the chest at weeks 0, 8, and 16 to quantitatively and objectively assess pigmentation.
RESULTS: Forty-two women completed the study. All dermatologist-graded aging parameters were significantly improved at each time point, P<0.001. Chromameter measurements demonstrated significant improvements in brightness (L*) and redness (a*), P<0.05. Self-assessed aging parameters were significantly improved on the décolletage and neck, P<0.05. Digital photography demonstrated obvious antiaging effects including improved texture of neck and décolletage areas, reduced appearance of lines and wrinkles, reduced mottled hyperpigmentation, and a more youthful, firm appearance. The test cream was well-tolerated with no significant changes in irritation parameters throughout the study.
CONCLUSION: The antiaging neck/décolletage cream delivered significant firming and smoothing effects with reduced appearance of hyperpigmentation and can be considered an effective topical homecare treatment option for patients seeking rejuvenation of this challenging area.
J Drugs Dermatol. 2016;15(1):47-52.
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.
Resident Rounds Part I. The State University of New York Downstate Medical Center Dermatology Residency Training Program
Jaimie B. Glick MD and Ravneet Ruby Kaur MD| |
Resident Rounds: Part 1 - Program Spotlight: The University of Colorado Denver Dermatology Residency Program
David A. Norris MD, Ramin Fathi MD| |
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.
Amy E. Rose MD| |
Resident Rounds: Part I - Program Spotlight: Western University of Health Sciences – Silver Falls Dermatology, Salem, Oregon
Bryce L. Desmond DO and Ben M. Perry DO| |
Eileen L. Axibal MD,a Julia D. Kreger MD,a Michael E. Contreras MD,b and Joel L. Cohen MD FAADa,b,c| |
Pearl E. Grimes MD| |
Six female subjects with Fitzpatrick skin types IV-V in good general health between the ages of 46 and 63 years with moderate epidermal facial melasma are presented herein. Subjects applied the skin brightener twice daily, morning and evening, and returned to the clinic at weeks 4, 8, and 12. By week 12, Investigator Overall Hyperpigmentation scores and MASI scores improved by an average of 22% and 38% from baseline, respectively. Additionally, 100% of subjects showed at least a 25% increase in Global Improvement at week 12. The skin brightener was well tolerated with no reports of erythema, edema, scaling, burning/stinging, or itching.
Results from these case studies suggest that this multimodality skin brightener may provide an alternative treatment to hydroquinone for moderate melasma in skin of color. However additional clinical studies would be needed.
J Drugs Dermatol. 2014;13(3):364-366.
Comparison of a Skin-Lightening Cream Targeting Melanogenesis on Multiple Levels to Triple Combination Cream for Melasma
Gary D. Monheit MDa and Frank Dreher PhDb| |
J Drugs Dermatol. 2013;12(3):270-274.
Shannon Famenini BS,a Nima M. Gharavi MD PhD,b and David P. Beynet MDb| |
J Drugs Dermatol. 2014;13(4):484-486.
Single Blind, Randomized, Controlled Trial of a Lightening Product With and Without Iontophoresis versus Tretinoin and Vehicle for Hyperpigmentation
Molly Wanner MD MBA,a Neil Houston BA,b Emilia Javorsky MPH,c Minsheng Yuan MD,d
Maria Alora-Palli MD,e Alexa B. Kimball MD MPHf
OBJECTIVE: To compare the efficacy of a new skin lightening product with and without iontophoresis to a known effective product (tretinoin) and placebo on hyperpigmentation caused by lentigines and/or melasma. Secondary objectives included an assessment of the product’s effects on the appearance of rhytides and roughness.
METHODS AND MATERIALS: Eighty subjects were randomized into one of four treatment groups: proprietary lightening product, proprietary lightening product with iontophoresis, tretinoin 0.05% cream, or vehicle control. Seventy-four subjects completed all study visits. Blinded assessments of subjects were performed at each visit under ambient and Wood’s light.
RESULTS: The proprietary skin lightening product improved facial hyperpigmentation versus placebo under ambient light (P = 0.05) and Wood’s lamp (P = 0.01) examination. Tretinoin also improved facial hyperpigmentation versus placebo under Wood’s lamp (P = 0.01). The proprietary product was better tolerated than tretinoin, with fewer subject reported side effects.
CONCLUSION: The investigational product was effective and may be better tolerated than tretinoin cream.
J Drugs Dermatol. 2015;14(1):13-18.
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.
Safety and Efficacy Evaluation of Tretinoin Cream 0.02% for the Reduction of Photodamage: A Pilot Study
Objective: We performed independent assessments to demonstrate the long-term safety and efficacy of tretinoin emollient cream 0.02% for moderate to severe facial photodamage.
Methods: A single-center, open-label, single-group observational study followed 19 patients over 52 weeks. Efficacy assessments consisted of the Glogau Photodamage Classification Scale and severity grading of photodamage signs and symptoms. Facial photography and biopsies were taken from three subjects at baseline and final visits. Tolerability was assessed by the investigator.
Results: Twelve patients completed 52 weeks of treatment. Mean change in Glogau photodamage demonstrated statistically significant differences at 3, 6, 9, and 12 months (P<.0005). All patients with moderate to severe photodamage had improved to mild photodamage status by 9 months. Statistically significant improvements (P<.05) were observed at all time points for fine wrinkling, tactile roughness, and mottled hyperpigmentation as well as for lentigines at 6, 9, and 12 months and telangiectasia at 12 months. Biopsy samples revealed microscopic improvement in photodamage. Tretinoin cream 0.02% was generally well-tolerated, with few subjects experiencing adverse events.
Limitations: Our pilot study is limited by lack of control and the small study sample.
Conclusions: Tretinoin cream 0.02% was safe and effective for moderate to severe photodamage of facial skin and demonstrated sustainable benefits over an entire year based on the clinically validated Glogau classification system and expert visual grading analysis.
J Drugs Dermatol. 2012;11(1):83-90.
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa| |
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.
An Evaluation of the Benefits of a Topical Treatment in the Improvement of Photodamaged Hands With Age Spots, Freckles, and/or Discolorations
Michael H. Gold MDa,b and Conor Gallagher PhDc| |
OBJECTIVE: To evaluate the efficacy of a topically applied cream formulated with an alpha-hydroxy acid, depigmenting agents, and antioxidants to improve the appearance of characteristics associated with photodamaged hands.
METHODS: This was a single-site, open-label study of a proprietary topical treatment (Vivité Vibrance Décolleté, Allergan, Inc.) in adult female subjects with moderate-to-severe photoaging of the hands. The treatment was administered to the hands twice daily over an 8-week period. Treatment efficacy was assessed at baseline and weeks 4 and 8 using the Investigator Global Assessment (IGA) score based on the percentage coverage and color depth of photodamaged areas. The severity of age spots, freckles, and hand skin discoloration were also assessed; digital and ultraviolet photography of the hands was performed. Subject-reported assessments of treatment efficacy were evaluated using a questionnaire administered at week 8. Statistical significance was defined with an α set at P≤.05.
RESULTS: Thirty-five subjects were enrolled with a mean age of 55.6 years; 33 subjects completed the study. The IGA of the appearance of hand photodamage improved from a mean (standard deviation) score of 5.0 (0.8) at baseline to 3.1 (1.5) and 2.6 (1.3) at weeks 4 and 8, respectively (1=mild; 9=severe). Based on expert-grader evaluation, subjects demonstrated statistically significant improvements from baseline in IGA at weeks 4 and 8 in age spots and freckling at weeks 4 and 8, (P<.0003) and in skin discolorations at week 8 (P<.05). The majority of subjects reported that they perceived improvements in each of the 9 parameters associated with skin appearance. No adverse events were reported.
CONCLUSIONS: The appearance of age-related hand pigmentation characteristics were significantly improved at 4 and 8 weeks of treatment. Subjects reported post-treatment improvements in other characteristics associated with healthy skin.
J Drugs Dermatol. 2013;12(12):1468-1472.
A Multicenter, Randomized, Vehicle-Controlled Phase 2 Study of Blue Light Photodynamic Therapy With Aminolevulinic Acid HCl 20% Topical Solution for the Treatment of Actinic Keratoses on the Upper Extremities: The Effect of Occlusion During the Drug Incubation Period
George J. Schmieder DO,a Eugene Y. Huang MD PhD,b and Michael Jarratt MDc| |
Objectives: To determine and compare the safety and ef!cacy of blue light ALA-PDT vs blue light placebo vehicle (VEH) in the treatment of AKs of the upper extremities and to evaluate the effect of occlusion after application of ALA vs VEH.
Methods: ALA or VEH was applied to both dorsal hands/forearms for the 3-hour incubation period before blue light treatment (10 J/ cm2). One extremity of each subject was covered with occlusive dressing during the incubation period. Treatment was repeated at week 8 if any AK lesions remained.
Results: The median AK lesion clearance rate at week 12 was 88.7% for extremities treated with occluded ALA (ALA+OCC), 70.0% for extremities treated with nonoccluded ALA, 16.7% for extremities treated with occluded VEH (VEH+OCC), and 5.6% for extremities treated with nonoccluded VEH (P<.0001). ALA+OCC resulted in a significantly higher clearance rate compared with the nonoccluded extremity at weeks 8 (P=.0006) and 12 (P=.0029). Thirty-four percent (12/35) of extremities treated with ALA+OCC had complete clearance of lesions at week 12 compared with 0% (0/35) of extremities treated with VEH+OCC (P=.0002). The safety pro!le in this study is consistent with previously reported side effects of the therapy.
Conclusion: Blue light ALA-PDT following a 3-hour incubation appears efficacious for AK clearance of the upper extremities. Incubation using an occlusive dressing significantly increases the efficacy of the procedure and also increases the incidence and severity of some acute inflammatory side effects of PDT.
J Drugs Dermatol. 2012;11(12):1483-1489.
Fran E. Cook-Bolden 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.
Michael H. Gold MD,a,b Leon H. Kircik MD,c-e Vivian W. Bucay MD,f,g
Monika G. Kiripolsky MD,h,i and Julie A. Biron BSca
OBJECTIVE: To determine the efficacy of a new topical formulation of 1% retinol and the effects of this same formulation using a 0.5% retinol concentration to minimize irritation.
METHODS: Patients at 2 sites (n=6, n=5) with photodamaged skin applied a novel suspension of retinol (1%) daily to their faces for 8 to 12 weeks. Clinicians graded improvement in ultraviolet-induced features at 4 to 6 weeks and at 8 to 12 weeks. Positive results of the observational pilot study warranted a follow-up study on the low concentration. At a third site, females (n=30) with facial photodamage applied the same formulation with or without retinol (0.5%) daily for 8 weeks. Twenty-two subjects applied the test product and 8 applied vehicle according to a randomized, double-blinded, institutional review board–approved protocol. Improvements in photodamage features were graded at 4 and 8 weeks.
RESULTS: In the observational pilot study, most participants showed improvement in overall photodamage, crow’s feet, elasticity,wrinkles, brightness, and hyperpigmentation at 60 to 80 days. Improvements at 60 to 80 days were greater than at 30 to 46 days. In the low-concentration study with 0.5% retinol, improvements were modest, most likely due to the lower retinol concentration. Burning, pruritus, dryness, and erythema were minimal with the 0.5% retinol concentration.
CONCLUSIONS: The topical formulation of 1% retinol improves photodamaged skin for at least 8 to 12 weeks. Although improvements with the 0.5% retinol were more modest, side effects such as burning, dryness, pruritus, and erythema during the 8-week study period were minimal. These encouraging results justify a longer-term study to determine whether topically applied 0.5% retinol can provide benefits comparable with those seen with topically applied 1% retinol.
J Drugs Dermatol. 2013;12(5):533-541.
Ramin Fathi MD1 and Joel L. Cohen MD FAAD1,2,3| |
J Drugs Dermatol. 2016;15(7):809-815.
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.
Comparative Study of Professional vs Mass Market Topical Products for Treatment of Facial Photodamage
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa| |
OBJECTIVE: This split face study compares a mass market skincare regimen with a prescription skin care regimen for improvement in photo damaged skin.
METHODS: Twenty-seven subjects with moderate photo damaged facial skin were enrolled. Each subject was consented and assigned with the mass market anti-aging system (Treatment A) to one side of the face and the prescription anti-aging system (Treatment B or Treatment C) to the other side of the face. Treatment B contained 13 subjects whom did not use 0.025% Retinol cream. Treatment C contained 14 subjects who used a 0.025% Retinol Cream. Subjects had 4 visits over 12 weeks for digital photography and surveys. Photographs were evaluated by blinded physicians.
RESULTS: Physician objective analysis showed all three systems to have a statistically significant clinical improvement in photoaged skin seen in as little as 4 weeks of use. Participant’s surveys rated the mass market system higher than both of the professional systems for visible skin changes, ease of use, and likelihood to recommend to a friend. Twelve of twenty-seven subjects preferred the mass market system for overall improvement while twelve thought each system gave the same improvement.
CONCLUSION: This study demonstrates that a mass marketed skin care system can give similar clinical improvements in photo-aged skin as a professionally dispensed prescription system and the majority of participants preferred the mass-marketed system.
J Drugs Dermatol. 2016;15(1):37-44.
Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region
Hema Sundaram MD,a Michael Gold MD,b Heidi Waldorf MD,c Mary Lupo MD,d Vivien L. Nguyen PharmD,e and Jwala Karnik MDe| |
METHODS: Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness, and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales.
RESULTS: Subjects’ self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema, and one case of mild eye irritation, both of which were respectively resolved.
CONCLUSIONS: This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.
J Drugs Dermatol. 2015;14(12):1410-1417.
Cutaneous Non-Tuberculous Mycobacterial Infections in the Outpatient Setting: Presentation of a Case, Review of the Literature, and Therapeutic Considerations
Tara Spicer and Kenneth Beer MD| |
J Drugs Dermatol. 2014;13(12):1495-1497.
Open-Label Evaluation of a Novel Skin Brightening System Containing 0.01% Decapeptide-12 in Combination With 20% Buffered Glycolic Acid for the Treatment of Mild to Moderate Facial Melasma
Sandra P. Ramírez MD,a Alfonso C. Carvajal MD,b Juan C. Salazar MD,c Gladys Arroyave MD,d Ana M. Flórez MD,e and Hector F. Echeverry MDf| |
J Drugs Dermatol. 2013;12(6):e106-e110.
Shlomit Halachmi, MD PhD,a Dan Ben Amitai MD,b,d and Moshe Lapidoth MD MPHc,d| |
MATERIALS and METHODS: Twelve consecutive patients with moderate to severe acne scarring, who had completed a series of fractional laser resurfacing, underwent microinjections of 20 mg/mL hyaluronic acid (HA) gel into discrete depressed acne scars on the face.
RESULTS: Immediate visual improvement was observed in all lesions. The procedure was well tolerated. Adverse events were limited to transient pinpoint bleeding at the injection site.
CONCLUSION: Microinjection of low viscosity HA offers a valuable technique for the treatment of discrete depressed acne scars.
J Drugs Dermatol. 2013;12(7):e121-e123.
Horatio F. Wildman MD and Richard D. Granstein MD| |
Objective Assessment of Erythema and Pigmentation of Melasma Lesions and Surrounding Areas in Long-Term Management Regimens With Triple Combination
Doris Hexsel MD,a,b Mariana Soirefmann MD MsC,a,b Juliana Dumêt Fernandes MD PhD,c and Carolina Siega BSca| |
OBJECTIVES: To evaluate the erythema and pigmentation of melasma lesions and the surrounding areas in patients receiving triple combination (TC: hydroquinone, tretinoin, and fluocinolone acetonide) regimens.
METHODS: Patients first received an 8-week daily TC treatment and were then randomized to twice weekly or tapering regimen with TC. Melanin and erythema levels of lesions and surrounding areas were objectively measured using a narrowband reflectance spectrophotometer.
RESULTS: Progressive reduction in the mean melanin levels was observed in the treatment phase. Following both maintenance regimens, there was no difference between melanin levels in the melasma lesions. Adverse effects were rare in both phases of the study and there was borderline reduction in erythema with regimen II.
CONCLUSION: Both maintenance regimens were effective in maintaining results obtained during the initial treatment phase, and were safe and well-tolerated. Erythema was less intense with the tapering regimen.
J Drugs Dermatol. 2014;13(4):444-448.
A Comparative Study of the Safety and Efficacy of 75% Mulberry (Morus alba) Extract Oil Versus Placebo as a Topical Treatment for Melasma: A Randomized, Single-Blind, Placebo-Controlled Trial
Glen Alvin MD, Nino Catambay MD, Ailynne Vergara MD, Maria Jasmin Jamora MD| |
Background: Melasma is an aesthetically undesirable skin condition which remains difficult to treat. Mulberry is a whitening agent with antioxidant properties.
Objective: To evaluate the safety and efficacy of 75% mulberry extract oil as a treatment for melasma versus placebo.
Patients and Methods: 50 patients were recruited and randomly assigned into two groups, with 25 treated with 75% mulberry extract oil and the other 25 treated with placebo. All patients had a negative repeat open application test (ROAT) to both mulberry extract and placebo. Patients were followed up regularly at four-week intervals for a total of eight weeks. The severity of the melasma was assessed using the melasma area and severity score (MASI), Mexameter reading, melasma quality of life score (MelasQOL) and any adverse events noted.
Results: The mean MASI score significantly improved from 4.076 (±0.24) at baseline to 2.884 (±0.25) at week 8 for the 75% mulberry extract oil group while the placebo group showed an improvement of a lesser magnitude. Mexameter readings for the mulberry group showed a significant drop from 355.56 (±59.51) at baseline to 312.52 (±57.03) at week 8 compared to the placebo group, whose Mexameter readings deteriorated from 368.24 (±46.62) at baseline to 372.12 (±44.47) at week 8. The MelasQOL score also improved tremendously for the 75% mulberry extract oil group, falling from 58.84 (SD: ±3.18) at baseline to 44.16 (SD: ±4.29) at week 8, unlike the placebo group that showed a less dramatic improvement from 57.44 (SD: ±4.66) at baseline to 54.28 (SD: ±4.79) at week 8. With regards to the adverse events, only mild itching was reported in four patients from the 75% mulberry extract oil group while there were 12 cases of either itching or erythema reported from the placebo group.
J Drugs Dermatol. 2011;10(9):1025-1031.
Leslie Baumann MDa and Brian Zelickson MDb| |
OBJECTIVE: The following study was performed to test the hypothesis that customized application of MFU-V at two focal depths will produce clinical results that are superior to treatment at a single focal depth.
METHODS AND MATERIALS: Adult subjects (N=71) with skin laxity in the lower face and neck were enrolled; 64 met all entrance criteria and received treatment. On the basis of physical and anatomical characteristics, patients were assigned in nonrandomized fashion to one of three treatment groups to undergo treatment on the submental, submandibular, lower neck, and platysmal areas with MFU-V at single or dual depths.
RESULTS: Among evaluable subjects (N=64), investigator-assessment and subject-self-assessment demonstrated improved aesthetic changes at 60, 90, and 180 days after treatment. Overall, subjects that received MFU-V at two focal depths to the entire treatment area achieved slightly greater aesthetic improvement than subjects receiving MFU-V at single focal depths. There were no unexpected adverse events.
CONCLUSION: Applying treatment with MFU-V at two focal depths may provide improved aesthetic results in some subjects.
J Drugs Dermatol. 2016;15(5):607-614.
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.
The projections of increases in the number of skin of color patients over the next several decades, necessitates expertise in cultural competence for health care providers. Acquiring competency begins with practitioners reflecting on their self identity and personal beliefs. Additionally, understanding African-American cultural habits and practices and their impact on disease is critically important. We review, in this article, the fundamentals of becoming cultural competent. Patients are best served when their physician embraces their culture, their view of the health care system as well as habits and practices.
J Drugs Dermatol. 2012;11(4):460-465.
Aanand N. Geria MD, Christina N. Lawson MD, Rebat M. Halder MD| |
J Drugs Dermatol. 2011;10(5):483-489.
Background: The non-inflammatory linear verrucous subtype of epidermal nevi (LVEN) although generally benign, can be aestheti-
cally displeasing and functionally disfiguring to patients.
Objective: To provide a permanent improvement in the clinical appearance of LVEN with minimal scarring.
Method: Electroplaning with Surgitron®FFPF EMC was the chosen method of treatment.
Results: Electroplaning is a simple, safe, and effective method for improving the appearance of non-inflammatory linear epidermal nevi.
J Drugs Dermatol. 2012;11(4):474-477.
Joel L. Cohen MD| |
METHODS: A patient with profoundly severe perioral photodamage etched-in lines underwent full-field ablative perioral resurfacing with an erbium laser (Contour TRL, Sciton Inc., Palo Alto, CA) that allows separate control of ablation and coagulation. The pre-procedure consultations included evaluation of the severity of etched-in lines, and discussion of patient goals, expectations, and appropriate treatment options, as well as a review of patient photos and post-treatment care required. The author generally avoids full-field erbium ablation in patients with Fitzpatrick type IV and above. For each of 2 treatment sessions (separated by approximately 4 months), the patient received (12 cc plain 2% lidodaine) sulcus blocks before undergoing 4 passes with the erbium laser at 150 μ ablation, no coagulation, and then some very focal 30 μ ablation to areas of residual lines still visualized through the pinpoint bleeding. Similarly, full-field ablative resurfacing can be very reliable for significant wrinkles and creping in the lower eyelid skin – where often a single treatment of 80 μ ablation, 50 μ coagulation can lead to a nice improvement.
RESULTS: Standardized digital imaging revealed significant improvement in deeply etched rhytides without significant adverse events.
CONCLUSION: For appropriately selected patients requiring perioral (or periorbital) rejuvenation, full-field ablative erbium resurfacing is safe, efficacious and merits consideration.
J Drugs Dermatol. 2015;14(11):1363-1366.
A Randomized, Blinded, Bilateral Intraindividual, Vehicle-Controlled Trial of the Use of Photodynamic Therapy With 5-Aminolevulinic Acid and Blue Light for the Treatment of Actinic Keratoses of the Upper Extremities
Background/Objective: Actinic keratoses (AKs) on the upper extremities are difficult to treat. This study compares the efficacy and tolerability of photodynamic therapy (PDT) using 20% 5-aminolevulinic acid solution (ALA) and blue light versus ALA vehicle and blue light for the treatment of AKs of the dorsal hand and forearm.
Methods: Subjects were treated twice at an eight-week interval by ALA with blue light on one hand and forearm and with ALA vehicle and blue light on the contralateral hand and forearm. ALA incubation time was two hours under occlusion. Efficacy and tolerability were compared.
Results: The mean lesion count reductions (58.4±22.2% and 24.8±20.6% four weeks after the second treatment for the ALA and vehicle-treated sides, respectively) differed significantly (P=0.0004). Eleven of 15 subjects (73%) in the ALA-treated side achieved at least 50 percent reduction in lesion count compared to only two subjects (13%) in the vehicle-treated side four weeks after the second treatment. The difference was significant (P=0.0143). Photodamage grade reduction was also significant (P=0.0309) after the second treatment. Subject satisfaction was moderate to very satisfied (86.7%) on the ALA-treated side. Transient adverse events were significantly greater on the ALA-treated side for erythema (P=0.0011), edema (P=0.0199) and stinging and burning (P=0.0016) 48 hours after the first treatment.
Conclusions: Two sessions of PDT using ALA with blue light is a moderately effective, well-tolerated treatment of actinic keratoses of the dorsal hand and forearm.
J Drugs Dermatol. 2011;10(9):1049-1056.
Allison P. Weinkle BS,a Bryan Sofen MD,b and Jason Emer MDc| |
J Drugs Dermatol. 2015;14(11):1215-1228.
Martin Ray MDa and Michael Gold MDb| |
J Drugs Dermatol. 2015;14(11):1268-1271.
J Drugs Dermatol. 2012;11(11):1296-1299.
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.
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.
Leon H. Kircik MD| |
Comparison of the Effects of Contractubex® Gel in an Experimental Model of Scar Formation in Rats: An Immunohistochemical and Ultrastructural Study
Mustafa T. Sahin MD,a Sevinc Inan MD,b Serap Ozturkcan MD,a Elif Guzel MDc Cemal Bilac MD,a Gülsen Giray MD,b Sevda Muftuoglu MDd| |
Background: Contractubex® gel, a commercial treatment for scars, consists of a mixture of onion extract (cepea extract), heparin sodium,
and allantoin. It exerts a softening and smoothing effect on indurated, hypertrophic, painful, and cosmetically-disfiguring scar tissue.
Aim: To compare and discuss the immunohistochemical and ultrastructural effects of treatment of an experimental scar in a rat model with Contractubex gel.
Methods: Thirty-two Sprague-Dawley rats were divided into four groups. Skin biopsies were taken to develop full thickness wounds. After 10 days, Contractubex gel, heparin, and allantoin were topically applied daily to groups 2, 3, and 4, respectively. Group 1 was the control group. On the 30th day, scar tissues were excised to investigate the immunohistochemical and ultrastructural effects of these agents. For this purpose we used TGF-beta, laminin, and fibronectin primary antibodies.
Results: Increased immunoreactivities of laminin, fibronectin, and TGF-beta in control group, moderate immunoreactivities in heparin and allantoin groups, and mild immunoreactivities in the Contractubex gel group were observed. In semi-thin sections, Group 2 showed the thinnest epidermis of the four groups. In electron micrographs of Group 2, completely keratinized and normally appearing cells could be seen.
Conclusions: Immunohistochemical and ultrastructural observations demonstrated that the Contractubex gel significantly improved the quality of wound healing and reduction of scar formation. Also, it was a more appropriate treatment choice than heparin monotherapy and allantoin monotherapy in keloidal and hypertrophic scars.
J Drugs Dermatol. 2012;11(1):74-81.
Safety and Effectiveness of Small and Large Gel-Particle Hyaluronic Acid in the Correction of Perioral Wrinkles
Background: FDA-approved for the correction of moderate-to-severe facial wrinkles and folds, small gel-particle hyaluronic acid (SGP-HA, Restylane,® Medicis Aesthetics, Inc., Scottsdale, AZ) and large gel-particle hyaluronic acid (LGP-HA, Perlane,® Medicis Aesthetics, Inc., Scottsdale, AZ) were studied to evaluate their safety for the correction of oral commissures, marionette lines, upper perioral rhytides and nasolabial folds (NLFs).
Objectives: The primary objective of this study was to investigate the safety of SGP-HA and LGP-HA in treating facial wrinkles and folds around the mouth; the secondary objective was to evaluate the effectiveness of these products.
Methods: This open-label, 4-week study at two US centers evaluated SGP-HA and LGP-HA in patients who intended to undergo intradermal injection for correction of of perioral wrinkles and folds. At screening, a 5-grade Wrinkle Severity Rating Scale (WSRS) was used to evaluate the baseline appearance of bilateral NLFs, and a 6-grade Wrinkle Severity (WS) scale was used to evaluate the appearance of bilateral oral commissures, marionette lines and upper perioral rhytides. To qualify, each patient must have had moderate-to-severe wrinkles at one pair of marionette lines and upper perioral rhytides. Each wrinkle was treated to optimal correction with either SGP-HA or LGP-HA at the discretion of the treating investigator. All reported local and systemic adverse events (AEs) were recorded. At two weeks after treatment or touch-up, the treating investigator and the patient assessed appearance using the Global Aesthetic Improvement Scale (GAIS).
Results: Twenty patients with a mean age of 59.6 years (range 49 to 65 years) were treated with an average of 5.58±1.15 mL of HA for the entire perioral area. Treatment areas included NLFs, marionette lines, oral commissures and perioral rhytides. Eighteen of 20 patients received both SGP-HA and LGP-HA. Product was injected into the mid or deep dermis using primarily linear threading and multiple punctate pools. Patients experienced a total of 66 treatment-emergent AEs (TEAEs); each patient experienced at least one TEAE. The reported events in decreasing order of occurrence were bruising, tenderness, swelling, redness, headache and discomfort. Bruising was more common in the NLFs and marionette lines than in the oral commissures and perioral rhytides. Tenderness occurred more often in the perioral rhytides than in the other areas. The maximum intensity of all TEAEs was considered mild. Most TEAEs resolved within seven days, with an average duration of four days. No serious TEAEs occurred during the study. One hundred percent of GAIS evaluations by both investigators and patients indicated improvement, regardless of filler used or area treated.
Conclusion: Both SGP-HA and LGP-HA were found to be safe and effective for the correction of perioral wrinkles and folds, with few differences among treatment areas Both investigator and patient GAIS evaluations indicated aesthetic improvement after SGP-HA and LGP-HA treatment in the perioral area.
J Drugs Dermatol. 2011;10(9):982-987.
Jonathan S. Weiss MD| |
J Drugs Dermatol. 2013;12(suppl 6):s70-s72.
The Impact of Natural Sunlight Exposure on the UVB-Sun Protection Factor (UVB-SPF) and UVA Protection Factor (UVA-PF) of a UVA/UVB SPF 50 Sunscreen
Thomas J. Stephens PhD,a James H. Herndon Jr. MD FAAD,b Luz E. Colón MS CCRC CCRA,c Ronald W. Gottschalk MD FRCPCc| |
Methods: These two randomized, controlled, evaluator-blinded, single-center trials were conducted according to the methods outlined in the 2007 Proposed Amendment to the Final Monograph, “Sunscreen Drug Products for Over-the-Counter Human Use.” Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal erythemal doses (MED) ranging from 2–16 MED (42–336 mJ/cm2). Three test sites were identified on the back of each study subject. Exposed sunscreen (one of four doses), unexposed sunscreen, and a UVB-SPF 15 control sunscreen were applied to the three test sites in a randomized fashion, followed by UV irradiation of incremental doses. Erythema and pigment darkening responses were assessed immediately following UV exposure and again 16–24 hours (erythema) or three to 24 hours (pigment darkening) after exposure. UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples.
Results: The calculated UVB-SPF and UVA-PF values for all test samples (exposed and unexposed) were >50 and >9, respectively, which were greater than the stated UVB-SPF and UVA-PF values on the product label. No differences were observed between the exposed and unexposed samples in UVB-SPF or UVA-PF.
Conclusion: The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable despite exposure of the sunscreen to natural sunlight containing UVB ranging from 2–16 MED (41–336 mJ/cm2) and coexistent UVA.
J Drugs Dermatol. 2011;10(2):150-155.
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.
Joel Schlessinger MD,a Subhash Saxena PhD,b and Stuart Mohrb| |
J Drugs Dermatol. 2016;15(4):496-503.
Robert M. Hurwitz MD, Larry J. Buckel MD, Thomas J. Eads MD| |
Objective: To demonstrate the pattern of cutaneous reactions related to PPI usage and to evaluate the risk of developing PPI drug eruptions among adult patients.
Methods: We reviewed the spontaneous reports of any adverse events associated with PPI use, as reported from January 2005 through May 2010 to the Adverse Drug Reaction Center at Siriraj Hospital in Thailand. Each control was sampled from 15 patients who had consecutive hospital numbers from each study case.
Results: The prevalence of cutaneous reactions to PPIs varied, ranging from three to 20 per 100,000 of the treated population. Sixty-four patients with a history of reaction to PPIs, and 65 controls were enrolled. Most cutaneous reactions were attributed to omeprazole (n=50; 78.1%), and the most frequently observed cutaneous reaction was maculopapular rash (43.8%). None of the patients experienced a cross-reaction between individual PPIs.
Conclusion: Cutaneous adverse reactions to PPIs range from minor drug rashes to a severe, life-threatening reaction. Individuals with a history of adverse drug reaction have an increased risk of cutaneous reaction to PPIs.
J Drugs Dermatol. 2012;11(10):e43-e47.
Prevalence and Risk Factors of Acne Scarring Among Patients Consulting Dermatologists in the Unites States
Jerry Tan MD,a/sup> Sewon Kang MD,b/sup> and James Leyden MDc| |
J Drugs Dermatol. 2017;16(2):97-102.
Pilot Evaluation of a Novel Topical Formulation Containing High Level, Cholesterol-Dominant, Physiological Lipids for Specific Targeting of Skin Barrier Deficits in Aging Skin
Hema Sundaram MD,a Ana Du BS,b Margarita Yatskayer MS,b Stephen Lynch PhD,b Yevgeniy Krol,c and Christian Oresajo PhDb| |
A Prospective Split-Face Study of the Picosecond Alexandrite Laser With Specialized Lens Array for Facial Photoaging in Chinese
Yiping Ge MD, Lifang Guo MD, Qiuju Wu MD, Mengli Zhang MD, Rong Zeng MD, and Tong Lin MD PhD| |
Ramsin Joseph Yadgar BS,a and Adam J. Friedman MDa,b| |
Stabilized Hyaluronic Acid-based Gel of Non-animal Origin for Skin Rejuvenation: Face, Hand, and Decolletage
Meike Streker MD, Tilmann Reuther MD, Nils Krueger MD PhD, and Martina Kerscher MD| |
OBJECTIVE: To assess the efficacy and safety of a stabilized HA-based gel of non-animal origin manufactured using the patented NASHA® technology (Restylane® Vital Light, Q-Med AB, Uppsala, Sweden) administered using a pre-filled micropuncture injector device for rejuvenation of the skin.
METHODS: Three treatment sessions 4 weeks apart were performed on one side of the face, the dorsum of one of the hands and one side of the decolletage, leaving the other side untreated. Skin quality was assessed via blinded live evaluation and subject satisfaction by questionnaire. Aesthetic change was evaluated independently by the subject and a blinded evaluator. Subjects were followed up to week 36.
RESULTS: Thirty subjects aged 40–65 years were enrolled. Overall skin quality across all three treatment areas was judged to be improved on the treated side in over 80% of subjects throughout the study. Significant aesthetic improvements on the treated sides were observed at all visits, with the exception of the decolletage at week 36.
CONCLUSIONS: This was the first study that used a micropuncture injector device for injection of NASHA gel, and reveals that this is a promising treatment option for rejuvenation of the skin.
J Drugs Dermatol. 2013;12(9):990-994.
J Drugs Dermatol. 2012;11(11):1316-1230.
J Drugs Dermatol. 2011;10(5):494-498.
Andrew F. Alexis MD MPH| |
A Randomized, Double-blind, Split-face Study Comparing the Efficacy and Tolerability of Three Retinol-based Products vs. Three Tretinoin-based Products in Subjects With Moderate to Severe Facial Photodamage
Michael Babcock MD,1 Rahul C. Mehta PhD,2 Elizabeth T. Makino BS CCRA MBA2| |
J Drugs Dermatol. 2015;14(1):24-30.
Scott KM Barr MD FRCPC,a Arie Benchetrit MD FRCPC,b Mariusz Sapijaszko MD FRCP,c
and Anneke Andriessen PhDd
OBJECTIVE: A 24-week study evaluated clinical efficacy with HA.
METHODS AND MATERIALS: Included were 15 healthy subjects recruited from 4 centers, between ages of 35 to 65 years, who had a Wrinkle Severity Rating Scale (WSRS) score ≥ 3, indicating moderate volume loss. Revanesse® Ultra (Prollenium), a HA dermal filler, was used. Primary study outcome was physicians scored facial volume correction, using the Global Aesthetic Improvement Scale (GAIS), comparing baseline (day 0) versus 24 weeks (end) and blindly assessed photographs. Subject satisfaction and comfort was evaluated using self-administered questionnaires at day 0 and at week 24.
RESULTS: N = 15, 13 female and 2 males with a mean age (years) of 48.52 ( SD ± 10.46) received treatment with HA and completed the 24-week study. At screening they had a moderate (mean 2.85, SD ± 0.45) WSRS score. At week 24 a market facial volume restoration was shown and no adverse events were reported. All patients reported to be satisfied with the obtained results.
CONCLUSION: Good – excellent volume enhancement was noted almost immediately after the HA injections, improving patient reported quality of life aspects. HA treatment was shown to be safe.
J Drugs Dermatol. 2015;14(1):19-23.
Antimicrobial Activity of Pomegranate and Green Tea Extract on Propionibacterium Acnes, Propionibacterium Granulosum, Staphylococcus Aureus and Staphylococcus Epidermidis
Zhaoping Li MD PhD,a,c,d,e Paula H. Summanen MS,a Julia Downes BS,a Karen Corbett BS,a Tomoe
Komoriya PhD,a,e Susanne M. Henning PhD,c,d Jenny Kim MD PhD,a,c,d and Sydney M. Finegold MDa,b,c
J Drugs Dermatol. 2015;14(6):574-578.
Prospective, Case-Based Assessment of Sequential Therapy With Topical Fluorouracil Cream 0.5% and ALA-PDT for the Treatment of Actinic Keratosis
George Martin, MD| |
The sequential use of topical therapies and short-incubation photodynamic therapy for actinic keratosis (AK) has not been extensively studied. The author reports on treatment with sequential 5-fluorouracil (5-FU) cream 0.5% and 5-aminolevulinic acid-photodynamic therapy (ALA-PDT) in three older men with photodamaged skin and a history of AK. These findings suggest that this combination therapy, when compared with short-contact (1 hour) ALA-PDT alone, is more effective, minimizes the recurrence of areas of field cancerization and improves the appearance of the skin. The use of 5-FU cream 0.5% before and after photodynamic therapy is effective in revealing the presence of both clinical and subclinical AK lesions.
J Drugs Dermatol. 2011;10(4):372-378.
A Phase I Safety and Pharmacokinetic Study of ATX-101: Injectable, Synthetic Deoxycholic Acid for Submental Contouring
Patricia Walker MD PhD,a,b Jere Fellmann PhD,b and Paul F. Lizzul MD PhD MBA MPHb| |
J Drugs Dermatol. 2015;14(3):279-284.
The Efficacy and Safety of Topical Dapsone Gel, 5% for the Treatment of Acne Vulgaris in Adult Females With Skin of Color
Andrew F. Alexis MD MPH,a Cheryl Burgess MD,b Valerie D. Callender MD,c Jo L. Herzog MD,d Wendy E. Roberts MD,e Eric S. Schweiger MD,f Toni C. Stockton MD,g and Conor J. Gallagher PhDh| |
OBJECTIVE: Evaluate safety and efficacy of dapsone gel, 5% applied topically twice daily for 12 weeks in women with SOC.
METHODS: Females with SOC aged 18 years and older with facial acne participated in a multicenter, open-label, single-group, 12-week pilot study of twice-daily monotherapy with dapsone gel, 5%. The investigator-rated 5-point Global Acne Assessment Score (GAAS) was used to assess efficacy. The impact of acne on subjects was assessed using the validated Acne Symptom and Impact Scale (ASIS).
RESULTS: The study enrolled and treated 68 women with SOC and facial acne. GAAS decreased significantly from baseline to week 12 (mean, -1.2 [95% CI, -1.4, -1.0]; P<.001), a 39.0% improvement. Overall, 42.9% of subjects were responders based on a GAAS of 0 or 1 at week 12. Subjects also experienced significant reductions in mean total lesions (52% decrease), inflammatory lesions (65%), and comedo counts (41%; all P<.001). Dapsone gel, 5% monotherapy was associated with significant improvement in subject-assessed acne signs (P<.001) and impact on quality of life (QOL; P<.001), based on ASIS. Dapsone gel, 5% used twice daily was well tolerated, with no treatment-related adverse events. The local dermal tolerability scores tended to remain stable or decrease from baseline to week 12.
CONCLUSIONS: Monotherapy with dapsone gel, 5% administered twice daily was safe and effective for treatment of facial acne in women with SOC. Significant improvement in overall acne severity and both inflammatory lesions and comedones was observed. Further, study subjects reported considerable improvement in both acne signs and impact on QOL.
J Drugs Dermatol. 2016;15(2):197-204.
Melanie Tuerk MD, Heidi Goodarzi MD, Summer Youker MD| |
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.
Hair Regrowth Following a Wnt- and Follistatin- Containing Treatment: Safety and Efficacy in a First-in-Man Phase 1 Clinical Trial
J Drugs Dermatol. 2011;10(11):1308-1312.
Leon H. Kircik MD| |
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.
Flor A. Mayoral MD,a Julie R. Kenner MD PhD,b and Zoe Diana Draelos MDc| |
J Drugs Dermatol. 2014;13(4):414-421.
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.
Effect of Different Crosslinking Technologies on Hyaluronic Acid Behavior: A Visual and Microscopic Study of Seven Hyaluronic Acid Gels
Patrick Micheels MD,a Didier Sarazin MD,b Christian Tran MD,c and Denis Salomon MDd| |
OBJECTIVE: To examine the different properties of a range of HA gels using simple and easily reproducible laboratory tests to better understand their suitability for particular indications.
METHODS AND MATERIALS: Hyaluronic acid gels produced by one of 7 different crosslinking technologies were subjected to tests for cohesivity, resistance to stretch, and microscopic examination. These 7 gels were: non-animal stabilized HA (NASHA® [Restylane®]), 3D Matrix (Surgiderm® 24 XP), cohesive polydensified matrix (CPM® [Belotero® Balance]), interpenetrating network-like (IPN-like [Stylage® M]), Vycross® (Juvéderm Volbella®), optimal balance technology (OBT® [Emervel Classic]), and resilient HA (RHA® [Teosyal Global Action]).
RESULTS: Cohesivity varied for the 7 gels, with NASHA being the least cohesive and CPM the most cohesive. The remaining gels could be described as partially cohesive. The resistance to stretch test confirmed the cohesivity findings, with CPM having the greatest resistance. Light microscopy of the 7 gels revealed HA particles of varying size and distribution. CPM was the only gel to have no particles visible at a microscopic level.
CONCLUSION: Hyaluronic acid gels are produced with a range of different crosslinking technologies. Simple laboratory tests show how these can influence a gel’s behavior, and can help physicians select the optimal product for a specific treatment indication.
Versions of this paper have been previously published in French and in Dutch in the Belgian journal Dermatologie Actualité. Micheels P, Sarazin D, Tran C, Salomon D. Un gel d’acide hyaluronique est-il semblable à son concurrent? Derm-Actu. 2015;14:38-43.
J Drugs Dermatol. 2016;15(5):600-606.
Kimberly Sansalone, Kenneth Beer MD, and Janelle Pavlis MD| |
J Drugs Dermatol. 2016;15(7):891-892.
A Two-Center, Open-Label, Randomized, Split-Face Study to Assess the Efficacy and Safety of One Versus Three Intradermal Injection Sites of AbobotulinumtoxinA in the Treatment of Lateral Periocular Rhytides
Sabrina G. Fabi MD,a Hema Sundaram MD,b Isabella Guiha BS,a and Mitchel P. Goldman MDa,| |
OBJECTIVE: To determine the efficacy of one versus three injection sites of AbobotulinumtoxinA (ABO) in the treatment of lateral canthal rhytides.
METHODS: This was a two-center, evaluator-masked, 120 day study in which 40 patients with moderate to severe hyperdynamic lateral canthal rhytides at maximal contracture were randomized to receive one injection of 36 Units of ABO into the middle of the lateral orbital rhytides on one side, with the contralateral side treated with the same total dose of ABO, divided into three intradermal injections of 12 Units each, along the lateral canthal area. A blinded evaluator assessed lateral orbital rhytides at rest and maximal contraction at baseline, 7, 42, 90, and 120 days post treatment. Standardized digital photography and subject self- assessment were performed at each visit.
RESULTS: No statistically significant difference was seen at any visit between sides treated with one injection and those treated with three injections in any evaluation category. There was no difference in adverse events between the two sides.
CONCLUSION: Sites treated with three injections of ABO showed no statistically significant difference from those treated with one injection.
J Drugs Dermatol. 2013;12(8):932-937.
Andrew F. Alexis MD MPH| |
J Drugs Dermatol. 2014;13(suppl 6):s61-s65.
J Drugs Dermatol. 2012;11(2):220-224.
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
Background: Melasma is a cutaneous disorder associated with an overproduction of melanin by the tyrosinase enzyme. A proprietary oligopeptide (Lumixyl TM ) was previously shown to competitively inhibit mushroom and human tyrosinase in vitro without the
associated cytotoxicity of hydroquinone and to diminish the appearance of facial melasma.
Objective: The aim of this case study was to determine if the Lumixyl Topical Brightening System (0.01% oligopeptide cream, an antioxidant cleanser, 20% glycolic acid lotion and physical sunscreen) accelerates clearance of mild-to-moderate melasma.
Results: All patients showed improvement in their facial melasma with 1 of 4 patients showing complete clearance after just 6 weeks.
Conclusions: Results suggest that this regimen may be a useful new tool to treat mild to moderate melasma.
J Drugs Dermatol.2012;11(5):660-662.
J Drugs Dermatol. 2012;11(7):879-880.
Macrene Alexiades MD PhD| |
J Drugs Dermatol. 2016;15(2):206-207.
Microneedling Prior to Levulan PDT for the Treatment of Actinic Keratoses: A Split-Face, Blinded Trial
James M. Spencer MD MSa,b and Scott A. Freeman PAb| |
METHODS: 20 patients each with at least 4 non hyperkeratotic AKs on each side of their face were enrolled. All patients were randomized to receive multiple passes with a microneedling device to ½ of their face, left or right, followed by application of Levulan to the entire face. The Levulan was allowed to incubate 1 hour followed by exposure to blue light (Blu U) for 1000 seconds.
RESULTS: 19 patients completed the study with 4-month follow up. The mean percentage reduction in AKs was 89.3% on the microneedling side versus 69.5% on the PDT alone side, a significant difference. A physician’s global cosmetic assessment was performed based on Canfield Visia photographs: 15 of the 19 patients had a noticeable improved cosmetic appearance on one side of the face versus the other, and in 13 of these patients the improved side was the microneedled side.
DISCUSSION: Prior microneedling significantly enhances the effect of Levulan PDT. It also seems to provide a cosmetic benefit above and beyond the PDT alone. It was safe and well tolerated in this study.
J Drugs Dermatol. 2016;15(9):1072-1074.
Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study
Dedee F. Murrell MD FRCP,a Kurt Gebauer MD,b Lynda Spelman MBBS FACD,c and Lee T. Zane MDd| |
METHODS: This phase 2a, randomized, double-blind, bilateral, 6-week study of crisaborole topical ointment, 2% was conducted in adult patients with mild to moderate AD with 2 comparable target AD lesions. Patients were randomly assigned to twice-daily application of crisaborole topical ointment, 2% or vehicle, each to 1 of the 2 target lesions. The primary efficacy endpoint was change from baseline in Atopic Dermatitis Severity Index (ADSI) score at day 28. Safety assessments included local tolerability and incidence of adverse events (AEs).
RESULTS: A total of 25 enrolled patients received study medication. At day 28, 17 patients (68%) experienced a greater decrease in ADSI score in the active-treated lesion than in the vehicle-treated lesion; 5 patients (20%) had a greater decrease in ADSI score in the vehicle-treated lesion than in the active-treated lesion. Local application-site reactions were reported in 3 patients (12%). A total of 29 AEs were reported in 11 patients; most (90%) were mild in intensity and unrelated to study medication. No serious or severe AEs were reported, and no patient discontinued due to an AE.
CONCLUSIONS: These findings provide preliminary evidence of the efficacy and safety of treatment with crisaborole topical ointment, 2% in adults with mild to moderate AD.
The study is registered on ClinicalTrials.gov (identifier NCT01301508).
J Drugs Dermatol. 2015;14(10):1108-1112.
Response to the Possibility of the Application of Topical Photodynamic Therapy Leading to Development of More Histologically Aggressive Subtypes of Basal Cell Carcinomas
Irene J. Vergilis-Kalner MD and Joel Cohen MD| |
Hannah Liu BS, Rachel Schleichert MD, and Anthony A. Gaspari MD| |
J Drugs Dermatol. 2013;12(3):360-361.
Noelani Gonzalez MD and Maritza Perez MD| |
J Drugs Dermatol. 2016;15(1):26-34.
Pain Management With a Topical Lidocaine and Tetracaine 7%/7% Cream With Laser Dermatologic Procedures
Joel L. Cohen MD| |
J Drugs Dermatol. 2013;12(9):986-989.
Macrene R. Alexiades-Armenakas MD PhD,a,b Jeffrey S. Dover MD,a-c and Kenneth A. Arndt MDc-e| |
J Drugs Dermatol. 2012;11(11):1274-1287.
J Drugs Dermatol. 2012;11(7):846-851.
Ife J. Rodney MD, Oge C. Onwudiwe MD, Valerie D. Callender MD, and Rebat M. Halder MD| |
J Drugs Dermatol. 2013;12(4):420-427.
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.
Ralph C. Daniel MD| |
J Drugs Dermatol. 2013;12(11):1263-1266.
Robert A. Swerlick MD aand Caren F. Campbell MD b| |
J Drugs Dermatol. 2013;12(1):99-102.
The Two Faces of Fractionated Photodynamic Therapy: Increasing Efficacy With Light Fractionation or Adjuvant Use of Fractional Laser Technology
Margit L.W. Juhasz MD,a,b Melissa K. Levin MD,a and Ellen S. Marmur MDa,c| |
The Therapeutic Effects of a Topical Tretinoin and Corticosteroid Combination for Vitiligo: A Placebo-Controlled, Paired-Comparison, Left-Right Study
Hyok Bu Kwon MD,a Yunseok Choi MD,a Hwa Jung Kim MD,b and Ai-Young Lee MDa| |
OBJECTIVE: The goal of this study was to determine the efficacy of tretinoin plus topical corticosteroids (tretinoin plus) for repigmentation in patients with vitiligo.
METHODS: A placebo-controlled, paired-comparison, left-right study was conducted for a period of 6 months on tretinoin plus and the vehicle plus the same topical corticosteroid (vehicle plus) treatment in 50 patients diagnosed with generalized vitiligo. Clinical responses were assessed using the computerized analysis, and the results were compared with the visual analysis.
RESULTS: The percentage agreement between the 2 analyses was 91.8%. Among 49 participants who successfully completed this study, 27 (55%) showed a better response to tretinoin plus than to vehicle plus. The improved response was noted at an early stage of treatment, during the first 3 months in 60% of patients.
CONCLUSION: Combined therapy with tretinoin plus topical corticosteroids is safe and effective and provides another option for treatment of patients with vitiligo.
J Drugs Dermatol. 2013;12(4):e63-e67.
Rebecca Kleinerman MD, Thomas H. King MD, and Daniel B. Eisen MD| |
J Drugs Dermatol. 2013;12(1):60-65.
Results of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Botulinum Toxin Type A Topical Gel for the Treatment of Moderate-to-Severe Lateral Canthal Lines
Richard Glogau MD,a,b Andrew Blitzer MD DDS,c Fredric Brandt MD,d Michael Kane MD,e Gary D. Monheit MD,f Jacob M. Waugh MDG| |
Objectives: To assess the safety and efficacy of RT001 for the treatment of lateral canthal lines in a randomized, double-blind, placebo-controlled study.
Materials & Methods: Adult subjects were enrolled to receive a single treatment of RT001 (n=45) or placebo (n=45) applied topically in the lateral canthal area. The primary endpoint was the composite of the Investigator Global Assessment of Lateral Canthal Line Severity (IGA-LCL) and the Patient Severity Assessment of lateral canthal line severity (PSA) defined as a 2-point or greater improvement on both scales.
Results: At four weeks, 44.4 percent of subjects treated with RT001 achieved a 2-point or greater improvement on a rigorous composite of both the IGA-LCL and PSA scales compared to 0.0% for the placebo subjects (P<0.0001). At four weeks, 88.9 percent of subjects achieved clinically relevant improvement by investigator assessment. Adverse events were mild in severity and unrelated to study treatment.
Conclusions: RT001 appears to be a safe and well-tolerated treatment for improvement of lateral canthal lines.
J Drugs Dermatol. 2012;11(1):38-45.
Tolerance and Efficacy of a Product Containing Ellagic and Salicylic Acids in Reducing Hyperpigmentation and Dark Spots in Comparison With 4% Hydroquinone
Amanda Dahl BS, Margarita Yatskayer MS, Susana Raab BS, and Christian Oresajo PhD| |
J Drugs Dermatol. 2013;12(1):52-58.
Kendra Gail Bergstrom MD FAAD| |
Efficacy and Tolerability of Two Commercial Hyperpigmentation Kits in the Treatment of Facial Hyperpigmentation and Photo-Aging
Objective: This investigator-blinded, randomized trial was undertaken to compare two commercial hyperpigmentation systems (kits) used for the treatment of facial hyperpigmentation and photo-aging.
Methods: Female subjects with at least mild facial hyperpigmentation and photo-aging were randomized to treatment with either the four product SkinMedica (SKM) regimen or the 7-product Obagi (OMP) regimen. Evaluations were conducted at baseline, 4, 8, and 12 weeks. Subjects were evaluated by the blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs were taken at baseline and week 12. Self-assessment questionnaires were completed at week 12. Thirty-five females (SKM=17, OMP=18) completed the 12-week study.
Results: Both treatment regimens showed a significant improvement at week 12 (compared to baseline) for Overall Hyperpigmentation, Global Photo-aging and Sallowness. At week 12, there was no significant difference between treatment groups in Global Response to Treatment. Tolerability was good for both regimens based on investigator assessments. Subject self-assessments showed no consistent differences in efficacy between the two regimens. Similarly, there was no significant difference in subject satisfaction or intent to continue use between the two regimens.
Conclusion: This clinical study demonstrated that both systems were equally effective at reducing hyperpigmentation and global photo-aging in females with mottled pigmentation and photodamaged facial skin.
J Drugs Dermatol. 2012;11(8):964-968.
Urticaria After Methyl Aminolevulinate Photodynamic Therapy in a Patient With Nevoid Basal Cell Carcinoma Syndrome
J Drugs Dermatol. 2012;11(11):1364-1365.
In Vitro PLK1 Inhibition by BI 2536 Decreases Proliferation and Induces Cell-Cycle Arrest in Melanoma Cells
J Drugs Dermatol. 2012;11(5):587-592.
The Use of Photodynamic Therapy as Chemoprevention for the Treatment of Actinic Keratoses and Reduction in the Number of Non-Melanoma Skin Cancers
Irene J. Vergilis-Kalner MDa and Joel L. Cohen MDb| |
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.
Topical Liposomal Rose Bengal for Photodynamic White Hair Removal: Randomized, Controlled, Double-Blind Study
Nevien Samy PhDa and Maha Fadel PhDb| |
OBJECTIVE: To investigate if repetitive sessions of photodynamic therapy (PDT) using external application of liposomal Rose bengal (RB) photosensitizer followed by intense pulsed light (IPL) exposure enables removal of gray and white hair.
MATERIALS and METHODS: Rose bengal loaded in liposomes (LRB) was constructed, prepared in hydrogel, and was studied for some pharmaceutical properties. Penetration and selective hair follicle damage in mice skin were studied. Topical gel containing LRB was used for treating fifteen adult females who were complaining of facial white terminal hair. Unwanted facial hair was treated for three sessions at intervals of 4–6 weeks using intense pulsed light (IPL). At each session, the treatment area was pre-treated with topical LRB gel, while a control group of another 15 patients applied placebo gel before IPL treatment. Evaluations included hair regrowth, which was measured 4 weeks after each treatment session and at 6 months follow-up by counting the number of terminal hair compared with baseline pretreatment values. Treatment outcomes and complications if any were also reported.
RESULTS: Average hair regrowth in the LRB group was 56% after 3 treatment cycles. After six-months follow up, average terminal hair count compared with baseline pretreatment showed 40% reduction and no recorded side effects. A significant difference (P<0.05) was seen compared with the control group; the clinical results were promising.
CONCLUSIONS: Photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with IPL treatment showed significant efficacy in the treatment of white hair compared with a control group.
J Drugs Dermatol. 2014;13(4):436-442.
Hilary E. Baldwin MD,a Marge Nighland BS,b Clare Kendall MA,c David A. Mays PharmD MBA,c Rachel Grossman MD,b,c and Joan Newburger PhDc| |
J Drugs Dermatol. 2013;12(6):638-642, e94-e105.
Derek Ho BS,a and Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2015;14(1):68-70.
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.
Evaluation of a Hydroquinone-Free Skin Brightening Product Using In Vitro Inhibition of Melanogenesis and Clinical Reduction of Ultraviolet-Induced Hyperpigmentation
Elizabeth T. Makino BS CCRA MBA,a Sujatha Sonti PhD,a Monya L. Sigler PhD,b Piyush Jain PhD,c Ajay Banga PhD,c and Rahul C. Mehta PhDa| |
METHODS: Select formulations were tested in several studies using the MelanoDerm™ Skin Model (MatTek Corporation, Ashland, MA) to assess the ability of the product to reduce melanin production and distribution. A single-center, double-blind comparison clinical study of 18 subjects was conducted to evaluate the efficacy of the product in reducing ultraviolet-induced hyperpigmentation. Test sites were irradiated with 1.0, 1.5, 2.0, and 2.5 minimal erythema doses. After 5 days, to allow for pigmentation development, the product or 4% HQ cream was applied to the respective test sites, once daily for 4 weeks. Chroma Meter measurements (L* brightness) and standardized digital photographs were taken of the test sites twice a week.
RESULTS: The test product resulted in greater reduction in melanin as measured by melanin content and histological staining compared with the positive control in the MelanoDerm Skin Model. The product also demonstrated statistically significant reductions in pigmentation compared with baseline (all P≤.0001) at the end of the clinical study, and produced greater increases in L*, compared with 4% HQ. Results from these studies indicate that a product designed to affect multiple pathways of melanogenesis and melanin distribution may provide an additional treatment option beyond HQ for hyperpigmentation.
J Drugs Dermatol. 2013;12(3 suppl 1):s16-s20.
Rosacea Fulminans With Extrafacial Lesions in an Elderly Man: Successful Treatment With Subantimicrobial-Dose Doxycycline
Lauren A. Smith MD, Shane A. Meehan MD, and David E. Cohen MD MPH| |
J Drugs Dermatol. 2014;13(6):763-765.
Mary L. Stevenson MD,a Julie K. Karen MD,a,b and Elizabeth K. Hale MDa,b| |
Photodynamic therapy (PDT) uses a topical photosensitizing agent which is activated by a light source to cause destruction of specific cells. Commonly used for the treatment of actinic keratoses and photodamage, PDT can also be used for other conditions including acne and sebaceous hyperplasia. Here we report our experience with two treatment protocols. The first protocol utilizes laser assisted delivery of topical 5-aminolevulinic acid for enhanced efficacy of blue light photodynamic therapy in the treatment of actinic keratoses and photodamage. The second protocol utilizes red light photodynamic therapy followed by pulsed dye laser to effectively target sebaceous glands in patients with extensive sebaceous hyperplasia.
J Drugs Dermatol. 2017;16(4):329-331.
Kenneth R. Beer MD FAAD,a Stephanie Bayers BSBA,b and Jacob Beerc| |
J Drugs Dermatol. 2014;13(suppl 1):s17-s20.
Levamisole Induced Necrosis of the Skin and Neutropenia Following Intranasal Cocaine Use: A Newly Recognized Syndrome
John Mouzakis MD,a Charurut Somboonwit MD,b Seetha Lakshmi MBBS,c Mark Rumbak MDd John Sinnott MD,e Basil Cherpelis MD,f Jonathan Keshishian MDg| |
Levamisole is a veterinary anti-helminthic used to treat several autoimmune conditions but also commonly utilized as an additive in cocaine distribution. Toxicity resulting in agranulocytosis and cutaneous necrosis in association with cocaine use is an infrequently described phenomenon of an emerging problem. Although levamisole is found extensively in the cocaine supply of the United States, relatively few cases of necrotic skin lesions associated with intranasal use have been reported. The skin necrosis secondary to levamisole toxicity is characterized by variable findings on biopsy, ranging from leukocytoclastic vasculitis to occlusive vasculopathy. The following case describes a 54-year-old male who developed fever, agranulocytosis, p-ANCA autoantibodies and extensive skin necrosis following heavy intranasal cocaine use. Necrosis of greater than 50% of the patient's total body surface area resulted and was followed by thorough wound debridement.
J Drugs Dermatol. 2011;10(10:1204-1207.
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.
Clobetasol Propionate 0.05% Spray for the Management of Moderate-to-Severe Plaque Psoriasis of the Scalp: Results From a Randomized Controlled Trial
Background: Clobetasol propionate 0.05% spray is available for treating moderate-to-severe plaque psoriasis; however, there is limited information with plaque psoriasis of the scalp.
Objective: Evaluate the efficacy, safety, and quality-of-life impact of clobetasol propionate 0.05% spray in patients with moderate to severe plaque psoriasis of the scalp.
Methods: Multicenter, randomized, double-blind, vehicle-controlled study involving 81 men and women with moderate-to-severe (Global Severity Score [GSS] = 3 or 4) plaque psoriasis of the scalp. Eligible patients were treated with clobetasol propionate 0.05% spray or vehicle spray, which was applied twice daily for up to four weeks. The primary efficacy end point was the GSS of psoriasis of the scalp after four weeks. Safety assessments included local tolerability, presence of Cushing's syndrome, and adverse events.
Results: At the end of treatment, 85 percent (35/41) of patients in the clobetasol propionate 0.05% spray group achieved success (GSS clear or almost clear), compared with 13 percent (5/40) in the vehicle spray group (P < .001). The proportion of patients treated with clobetasol propionate 0.05% spray who achieved a rating of clear (GSS = 0) after two weeks and at the end of treatment was 12 percent and 51 percent, respectively. Clobetasol propionate 0.05% spray was well tolerated, and there were no serious adverse events or reported cases of folliculitis or Cushing's syndrome.
Conclusion: Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp.
J Drugs Dermatol. 2011;10(8):888-895.
Kathleen J. Smith MD| |
Access of Efinaconazole Topical Solution, 10%, to the Infection Site by Spreading Through the Subungual Space
Boni E. Elewski MD,a Richard A. Pollak, DPM MS,b Radhakrishnan Pillai PhD,c Jason T. Olin PhDd| |
METHODS: 11 patients (mean age 48.5 years) were entered with clinically determined onychomycosis. Presence of fungal infection was confirmed by KOH testing in eight patients. Two separate applications of vehicle (with fluorescein incorporated for better visualization) were applied at the hyponychium, avoiding application to the exterior nail plate surface. Affected nails were later clipped to allow examination of the nail bed and further examination of the underside of the nail. Spread of formulation was assessed under visible and UV light conditions by photographing target toenails after vehicle application, and after nail clipping.
RESULTS: Assessments under both visible and UV light indicated that the vehicle had spread into the subungual space, with deposition of flourescein wherever vehicle had reached, including in the nail bed. Nail clippings also indicated deposition to the underside of the nail plate.
LIMITATIONS: The relative contributions of spreading into the subungual space, or permeation through the nail plate to the efficacy of efinaconazole topical solution, 10% in treating onychomycosis were not assessed.
CONCLUSIONS: This study suggests that the vehicle developed for efinaconazole topical solution, 10%, when applied at the hyponychium, spreads into the subungual space between the nail plate and nail bed, reaching the site of infection.
J Drugs Dermatol. 2014;13(11):1394-1398.
DeoxyArbutin and Its Derivatives Inhibit Tyrosinase Activity and Melanin Synthesis Without Inducing Reactive Oxygen Species or Apoptosis
J Drugs Dermatol. 2012;11(10):e28-e34.
Nils Krueger PhD,a Stefanie Luebberding MSc,a Gerhard Sattler MD,b C. William Hanke MD,c
Macrene Alexiades-Armenakas MD,d and Neil Sadick MDe
J Drugs Dermatol. 2013;12(7):737-742.
Leon H. Kircik MD| |
J Drugs Dermatol. 2016;15(Suppl 2):s44-48.
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for Rosacea: Summary of a Placebo-Controlled, Double-Blind Trial
J Drugs Dermatol. 2012;11(12):1410-1414.
A Randomized, Double-Blind, Vehicle-Controlled Crossover Study to Determine the Anti-Pruritic Efficacy, Safety and Local Dermal Tolerability of a Topical Formulation (SRD174 Cream) of the Long-Acting Opiod Antagonist Nalmefene in Subjects With Atopic Dermatitis
Jo Lynne Herzog MD,a James A.Solomon MD PhD,b Zoe Draelos MD,c Alan Fleischer Jr. MD,d Dow Stough MD,e David I.Wolf MD,f William Abramovits MD,g William Werschler MD,h Emma Green BSc,i Maeve Duffy PhD,i Alan Rothaul PhD,i Robert Tansley MBBSi| |
Objective: To investigate the efficacy, safety and tolerability of topical nalmefene (SRD174), a long acting opioid antagonist for the management of pruritus associated with atopic dermatitis (AD).
Design: Double-blind, vehicle-controlled, randomized, cross-over trial.
Setting: Eleven dermatology outpatient clinics in the U.S.
Patients: Sixty-two out of 136 screened adult subjects with confirmed AD affecting ≤20% of body surface area and with moderate-to-severe pruritus.
Interventions: SRD174 cream or matching vehicle cream applied as required during two 7-day periods separated by a wash-out period.
Main Outcome Measure(s): The primary efficacy variable was the period mean of the sum of pruritus intensity difference (SPID) from 0 to 4 hours (SPID0-4) where pruritus was measured on a 0-100 scale Visual Analog Scale (VAS) at seven pre-specified time-points following study drug application. A range of secondary efficacy, safety and tolerance endpoints were included.
Results: The LS means for the SPID0-4 (±SD) for SRD174 cream and Vehicle were 210.7 (20.4) and 212.1 (20.2), respectively (Difference = -1.3 (95% CI: -25.9, 23.3). None of the secondary efficacy endpoints tested demonstrated a statistically significant or clinically important difference between the test product and the vehicle. Overall, the SRD174 cream was well tolerated although there was a higher incidence of AEs when subjects took SRD174 cream (22, 36.7 percent of subjects) compared with when they were taking vehicle (14, 23.3 percent of subjects).
Conclusions: SRD174 cream did not demonstrate efficacy in the treatment of pruritus associated with atopic dermatitis raising questions on the role of peripheral opioid receptors as a target for the treatment of pruritus in this population. NCT00838708
J Drugs Dermatol. 2011;10(8):853-860.
Comparative Study of Hydroquinone-Free and Hydroquinone-Based Hyperpigmentation Regimens in Treating Facial Hyperpigmentation and Photoaging
Sabrina G. Fabi MD and Mitchel P. Goldman MD| |
OBJECTIVE: This investigator-blinded, randomized trial was conducted to compare a new hydroquinone (HQ)-free hyperpigmentation regimen against a leading HQ-based hyperpigmentation regimen for the treatment of facial hyperpigmentation and photoaging.
METHODS: Subjects with mottled pigmentation and photodamaged facial skin were randomized to treatment with either the new 4-product (HQ-free) SkinMedica® Hyperpigmentation System (SKM; SkinMedica, an Allergan Company, Carlsbad, CA) kit or the 7-product (HQ-containing) Obagi Nu-Derm System (OMP; Obagi Medical Products, Long Beach, CA) kit. Subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales at baseline and at weeks 4, 8, and 12. Standardized digital photographs were taken at baseline and week 12. Self-assessment questionnaires were completed at week 12.
RESULTS: Thirty-six female subjects (16: SKM; 20: OMP) completed the 12-week comparative study. Both hyperpigmentation regimens significantly reduced Overall Hyperpigmentation, Mottled Pigmentation Area and Severity Index (MoPASI), global photoaging, and sallowness at week 12 compared to baseline. Significant reductions in tactile roughness were seen with the OMP regimen at week 12. In these investigator-blinded assessments, there were no significant differences between treatment groups, nor was there a difference in global response to treatment. Investigator assessments of tolerability showed mean scores were mild or below for all parameters with both treatment regimens.
CONCLUSION: A new 4-product (HQ-free) regimen was shown to be as effective and tolerable as a 7-product (HQ-based) regimen in reducing facial hyperpigmentation and photoaging in females with mottled pigmentation and photodamaged facial skin.
J Drugs Dermatol. 2013;12(3 suppl 1):s32-s37.
Managing Occupational Irritant Contact Dermatitis Using a Two-Step Skincare Regimen Designed to Prevent Skin Damage and Support Skin Recovery
Erika C. von Grote PhD, Kiruthi Palaniswamy PharmD, and Matthew H. Meckfessel PhD| |
Spotlight on the Use of Nitric Oxide in Dermatology: What Is It? What Does It Do? Can It Become an Important Addition to the Therapeutic Armamentarium for Skin Disease?
James Q. Del Rosso DO FAOCD FAADa,b,c and Leon Kircik MDd,e,f,g| |
Adam J. Luber BA, Shaheen H. Ensanyat BS, and Joshua A. Zeichner MD| |
J Drugs Dermatol. 2014;13(2):130-134.
Frank Dreher PhD| |
J Drugs Dermatol. 2016;15(4):457-464.
Protective Effects of a Topical Antioxidant Complex Containing Vitamins C and E and Ferulic Acid Against Ultraviolet Irradiation-InducedPhotodamage in Chinese Women
Yan Wu MD PhD,a* Xin Zheng,a* Xue-Gang Xu MD,a Yuan-Hong Li MD PhD,a Bin Wang PhD,a Xing-Hua Gao MD PhD,a Hong-Duo Chen MD,a Margarita Yatskayer MS,b and Christian Oresajo PhDb,c| |
METHOD: Twelve healthy female Chinese subjects were enrolled in this study. Four unexposed sites on dorsal skin were marked for the experiment. The products containing antioxidant complex and vehicle were applied onto 2 sites, respectively, for 4 consecutive days. On day 4, the antioxidant complex-treated site, the vehicle-treated site, and the untreated site (positive control) received ssUVR (5 times the minimal erythema dose). The fourth site (negative control) received neither ssUVR nor treatment. Digital photographs were taken, and skin color was measured pre- and postirradiation. Skin biopsies were obtained 24 hours after exposure to ssUVR, for hematoxylin and eosin and immunohistochemical staining.
RESULTS: A single, 5 times the minimal erythema dose of ssUVR substantially induced large amounts of sunburn cell formation, thymine dimer formation, overexpression of p53 protein, and depletion of CD1a+ Langerhans cells. The antioxidant complex containing vitamins C and E and ferulic acid conferred significant protection against biological events compared with other irradiated sites.
CONCLUSION: A topical antioxidant complex containing vitamins C and E and ferulic acid has potential photoprotective effects against ssUVR-induced acute photodamage in human skin.
J Drugs Dermatol. 2013;12(4):464-468.
Alejandra Vivas MD,a Joshua D. Fox BS,a Katherine L. Baquerizo Nole MD,a Andrea D. Maderal MD,a Evangelos Badiavas MD PhD,a D. Innes Cargill PhD,b Herbert B. Slade MD,b Steven R. Feldman MD PhD,c Robert S. Kirsner MD PhDa| |
METHODS: On forearms of 8 healthy adult volunteers, freeze injuries were induced using liquid nitrogen spray delivered onto a target area of a 1 cm circular opening at a distance from the cryo-device to the skin of 0.5-1 cm. Several freeze-thaw time cycles were implemented by administering pulses ranging from 3 to 12 seconds. Clinical evaluation was performed at a 24-hour follow-up period. Blister roofs were histologically analyzed by a blinded dermatophathologist. Clinical assessment of time to heal was determined.
RESULTS: Freeze-times greater than 5 seconds caused a majority of subjects to develop blisters, and freeze-times greater than 8 seconds resulted in uniform blister formation. Consistent histology of full thickness necrotic epidermis with intact detached basement membrane with minimal acute neutrophilic inflammatory infiltrate was observed in all blister specimens examined. The 8-second freeze-time group had a time to heal of 13-14 days, while the 12-second freeze-time group required 3 weeks to heal. After healing, an area of hypopigmented skin and slightly hypertrophic scarring remained.
DISCUSSION: This novel cryo-induced wound model is a potential simple, efficient and reliable model for studying the dynamic processes involved in acute wound healing and to aid in the development of new wound healing therapies.
Clinicaltrials.gov identifier: NCT01253135.
J Drugs Dermatol. 2015;14(7):734-738.
A High-Potency, Multimechanism Skin Care Regimen Provides SignificantAntiaging Effects: Results From a Double-Blind, Vehicle-Controlled Clinical Trial
Patricia K. Farris MD, Brenda L. Edison BA, Irina Brouda MA, Ronni L. Weinkauf PhD, andBarbara A. Green RPh MSPatricia K. Farris MD,a Brenda L. Edison BA,b Irina Brouda MA,b Ronni L. Weinkauf PhD,b and Barbara A. Green RPh MSb| |
J Drugs Dermatol 2012;11(12):1447-1454.
Combination of Essential Oil of Melaleuca alternifolia and Iodine in the Treatment of Molluscum Contagiosum in Children
Molluscum contagiosum is a common childhood viral skin condition and is increasingly found as a sexually transmitted disease in adults. Current treatment options are invasive, requiring tissue destruction and attendant discomfort. Fifty-three children (mean age 6.3+5.1 years) with the diagnosis of molluscum contagiosum were treated with twice daily topical application of either essential oil of Melaleuca alternifolia (TTO), a combination of TTO and organically bound iodine (TTO-I), or iodine alone. At the end of 30 days, 48 children were available for follow up. A greater than 90% reduction in the number of lesions was observed in 16 of 19 children treated with TTO-I, while 1 of 16 and 3 of 18 children met the same criteria for improvement in the iodine and TTO groups (P<0.01, ANOVA) respectively by intention-to-treat analysis. No child discontinued treatment due to adverse events. The combination of essential oil of M. alternifolia with organically bound iodine offers a safe therapeutic alternative in the treatment of childhood molluscum. Clinical Trial Registry ACTRN12610000984099.
J Drugs Dermatol. 2012;11(3):349-354. 2012;11(3):349-354.
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.
Pyoderma Gangrenosum Following Breast Reconstructive Surgery: A Case Report of Treatment With Immunosuppression and Adjunctive Xenogeneic Matrix Scaffolds
Amy E. Rose MD| |
Patricia Farris MD,a,b Jean Krutmann MD,h Yuan-Hong Li MD PhD,i
David McDaniel MD,c,d,e,f,g and Yevgeniy Krolj
J Drugs Dermatol. 2013;12(12):1389-1394.
Alina Markova MD,a Rene Duquesnoy PhD,b and William Levis MDc| |
Real-time, High-resolution, In Vivo Characterization of Superficial Skin With Microscopy Using Ultraviolet Surface Excitation (MUSE)
Derek Ho BS,a,b Farzad Fereidouni PhD,c Richard M. Levenson MD,c and Jared Jagdeo MD MSa,b,d| |
Comparative Study of Topical 80% Trichloroacetic Acid With 35% TrichloroaceticAcid in the Treatment of the Common Wart
Fakhrozaman Pezeshkpoor MD,a Mahnaz Banihashemi MD,a Mohammad Javad Yazdanpanah MD,a Hadis Yousefzadeh,b Mohammad Sharghi MD,c Hossein Hoseinzadehd| |
Methods: In this single-blinded clinical trial, 62 eligible patients with common warts referred to the dermatology clinic of Ghaem Hospital in Mashhad, Iran. Patients were randomly divided into two groups, each treated with a TCA solution (group A, TCA 80%; group B, TCA 35%) once per week until complete clearance of the lesions or for a maximum duration of six weeks. Seven patients were excluded from the final analysis (one patient in group A and six patients in group B) for various reasons, including irregular follow-up, using physical tools such as razor blades to remove the lesion, and failure to complete treatment; and 55 patients were included in the final analysis.
Results: Improvement to treatment responses was classified as: no change (no changes in the number of warts), mild (clearing of less than 25% of warts), moderate (clearing of 25% to 75% of warts), and good (clearing of more than 75% of warts). At the end of follow-up, the clinical improvement of group A (n=30) was: 10 patients (33.3%) with a mild response, 6 patients (20%) with a moderate response, and 14 patients (46.7%) with a good response. In group B (n=25), 16 patients (64%) showed a mild response, 6 patients (24%) a moderate response, and 3 patients (12%) a good response. There was a statistically significant difference in improvement between the two treatment groups (P=.017). Improvement was greater with a higher concentration of TCA solution.
Conclusion: This study showed that a different concentration of TCA solution was an effective form of treatment for common warts. Trichloroacetic acid 80% is more effective, but this solution must be used only with careful consideration by a physician.
J Drugs Dermatol. 2012;11(11)e66-e69.
The Emervel French Survey: A Prospective Real-Practice Descriptive Study of 1,822 Patients Treated for Facial Rejuvenation With a New Hyaluronic Acid Filler
David Farhi MD,a,b Patrick Trevidic MD,c Philippe Kestemont MD,d Dominique Boineau MD,e
Hugues Cartier MD,f Isaac Bodokh MD,g Patrick Brun MD,g Benjamin Ascher MD,h
and Jacques Savary MD,b,i for the Emervel French Survey Group
OBJECTIVES: To describe the current use of Emervel fillers in France.
METHODS: Prospective multicenter, cross-sectional, real-practice, descriptive survey, including 1,822 patients injected with Emervel fillers for face rejuvenation by 58 French physicians between September 2010 and July 2011. The injection modalities were left to the respective physician’s discretion.
RESULTS: The physicians were dermatologists (52.3%), surgeons (43.8%), or general practitioners (14.1%). Nasolabial folds (NLF) with a mean severity 2.4 were mainly injected with Emervel Deep (51.0%) and Emervel Classic (36.0%) (mean volume: 1.0 mL), and primarily with the linear retrograde (LR) technique (89.3%). Marionette lines (ML), with a mean severity 2.6 were mainly injected with Emervel Deep (52.5%) and Emervel Classic (34.6%) (mean volume: 0.8 mL), and mainly with the LR technique (79.5%). More than 90% of patients had scores of 0 or 1 for erythema, bruising, edema, and pain. No serious adverse events were reported up to 15 months after the injection.
CONCLUSION: These data could contribute to upcoming international consensus on optimal injection modalities of the Emervel range of HA fillers.
J Drugs Dermatol. 2013;12(5):e88-e93.
Fractional CO2 Laser Treatment vs Autologous Fat Transfer in the Treatment of Acne Scars: A Comparative Study
Omar A. Azzam MD a, Ahmed T. Atta MDb, Rehab M. Sobhi MD, and Pakinam I.N. Mostafa MSca| |
Objective: To compare fractional CO2 laser treatment and fat grafting in the treatment of acne scars.
Materials and methods: Twenty patients were included in this study, 10 received 3 sessions of fractional CO2 laser therapy, and 10 received fat grafting. All patients were then followed up for 3 months, and results were assessed with digital photographs taken by a committee of 3 physicians, by a single-blinded physician, and by reports of patient satisfaction.
Results: In the fractional CO2 laser treatment group, under 20% of patients were graded as having excellent scar improvement, 0 as having marked scar improvement, under 10% as having mild scar improvement, and almost 70% as having moderate scar improvement. In the fat-grafting group, the scar and overall improvement were graded as 30% excellent, 30% marked, 20% moderate, and 20% mild.
Conclusion: Fat grafting proved to be more effective in the treatment of acne scars than ablative fractional CO2 laser treatment. There were many points in its favor, the most significant being the clinical improvement in scars and texture. This supports the stem cell theory of adipose tissue in regenerative medicine.
J Drugs Dermatol. 2013;12(1):e7-e13.
Julia Schwartz MDa and Adam J. Friedman MDa,b| |
Whitney P. Bowe MD| |
J Drugs Dermatol. 2013;12(suppl 9):s133-s136.
J Drugs Dermatol. 2013;12(10):1177-1179.
Amanda Pickert BS, Michele Hughes MD, Michael Wells MD| |
Sorafenib is a chemotherapeutic agent primarily used to treat metastatic renal cell carcinoma. It is a multikinase inhibitor that blocks cell proliferation and angiogenesis. Numerous cutaneous side effects have been reported in association with this medication, including acral erythema, inflammation of actinic keratoses, erythema multiforme, vasculitis, and keratoacanthomas. Up to 40 percent of patients on this medication develop dermatologic manifestations. We describe chloracne-like eruptions in two different patients with no exposure to aromatic hydrocarbons but who were recently started on sorafenib for treatment of metastatic renal carcinoma. The primary reason for discontinuation of sorafenib is secondary to its adverse side effect profile. Recognizing these effects early and administering appropriate treatment will likely increase medication compliance and minimize both dose reductions and discontinuation of the medication resulting in optimal treatment outcomes.
J Drugs Dermatol. 2011;10(11):1331-1334.
Objective: To evaluate their therapeutic regimen of 8% and 10% topical precipitated sulfur in petrolatum ointment for single day, three successive nights or three successive days in management of scabies.
Patients and Methods: This single-blinded, comparative study was conducted in the Department of Dermatology-Baghdad Teaching Hospital from April 2008 through October 2009. A total of 97 patients with scabies were enrolled in this study. The diagnosis was established on clinical basis. The patients treated with 8% and 10% topical sulfur in petrolatum ointment were divided randomly into three groups: Group A: 33 patients treated for single day (24 hours); Group B: 32 patients treated for three successive nights (from 6 p.m. to 8 p.m. to 6 a.m. to 8 a.m. and bathing every day); and Group C: 32 patients treated for three successive days (bathing every 24 hours). The patients were seen regularly every two weeks for the duration of four weeks.
Results: Study included 58 (59.8%) males and 39 (40.2%) females, with a male to female ratio 1.4:1. The age range of males at presentation from 3 to 64 (26.74±15.98) years, while the females age ranged at presentation from 3 to 60 (24.05±14.53) years of age. At the end of the study, the response to treatment was: Group A, response in 14 (42.4%) patients and no response in 19 (57.6%); Group B, response in 29 (90.6%) patients and no response in 3 (9.4%); and Group C, response in 31 (96.9%) patients and no response in 1 (3.1%). There is significant statistical difference among the response of 3 groups with (P=0.00000011), but no statistically significant difference between the response of Group C and Group B, (P=0.6055). Mild burning sensation and irritating (sulfur) dermatitis were the only side effects of 8% and 10% sulfur. Pruritic rash occurred in Group C mainly, in 11 (34.4%) patients, 8 (25%) in Group B and 4 (12.1%) in Group A, with no significance (P=0.1058). Recurrence or relapse occurred in Group A mainly, with 4 (12.1%) patients, and in Group B, 1 patient, (3.1%), with no recurrence in group C, with significance (P=0.0060).
Conclusion: Three successive days and three successive nights of 8% and 10% sulfur ointment were effective regimens with no statistical difference in favor of three successive days, while single-day application was much less effective but with fewer side effects.
J Drugs Dermatol. 2012;11(3):357-364.
Mohamed L. Elsaie MD MBA,a,b Mahmoud F. Abdelhamid MD PhD,b
Lotfy T. Elsaaiee MD PhD FACTM,c and Hanaa M. Emam MD PhD b
Background: Botanical extracts and preparations have been used in different pathological conditions with success. An important group of phytochemical phenolic compounds are the catechins found in green tea. Acne is a widely occurring inflammatory condition that is estimated to affect 40 to 50 million Americans. Finding an effective, safe, cost-effective and well-tolerated treatment is the challenge.
Objective: To determine the efficacy of 2% green tea lotion in mild-to-moderate acne vulgaris.
Methods: Twenty patients fulfilling enrolment criteria were included. Green tea was given and applied twice daily for a period of 6 weeks. The patients were seen every 2 weeks to evaluate the lesions and any side effects. To determine efficacy on acne severity, the authors used both total lesion count (TLC) and their devised severity index (SI). Total lesions count (TLC) was calculated as papules + pustules while SI was scaled with numbers (1, 2 or 3) correlating to TLC in order of increasing intensity. TLC < 10 was given an SI of 1, TLC 10-20 was given an SI of 2 and TLC > 20 was given an SI of 3.
Results: The mean total lesion count (TLC) decreased from 24 before the treatment to 10 after 6 weeks after treatment, a reduction of 58.33%. The difference was statistically significant (P < 0.0001, 95% confidence interval [CI] of the difference = 8.58 – 19.42). The mean severity index (SI) decreased from 2.05 before treatment to 1.25 after 6 weeks treatment, a decrease of 39.02%. The difference was statistically significant (P < 0.0001, confidence interval [CI] of the difference = 0.54-1.26).
Conclusion: Topical 2% green tea lotion is an effective, cost-effective treatment for mild-to-moderate acne vulgaris.
Jerry Bagel MD| |
Reconstruction of Full-Thickness Defects With Bovine-Derived Collagen/Elastin Matrix: A Series of Challenging Cases and the First Reported Post-Burn Facial Reconstruction
J Drugs Dermatol. 2012;11(7):866-868.
In Vitro Nail Penetration of Tavaborole Topical Solution, 5%, Through Nail Polish on Ex Vivo Human Fingernails
Tracey Vlahovic DPM,a Tejal Merchant MPharm,b Sanjay Chanda PhD,b Lee T. Zane MD,b and Dina Coronado BSb| |
OBJECTIVE: To evaluate the in vitro nail penetration properties of tavaborole topical solution, 5%, through nail polish using ex vivo, non-diseased human fingernails.
METHODS: In study 1, tavaborole penetration was evaluated over 20 days of dosing using the Franz finite dose technique and modified Franz diffusion cells. Nails received either 1 coat of over-the-counter (OTC) typical polish or were left unpolished (controls). In study 2, tavaborole penetration was measured over 14 days of dosing using the finite dose technique and vertical diffusion cells. Nails were polished with either 4 coats or 1 coat of salon typical polish or with 2 coats or 1 coat of OTC typical polish, or they were left unpolished.
RESULTS: In study 1, the mean ± standard deviation (SD) cumulative tavaborole penetration at day 21 was numerically higher, though not statistically significant, through polished nails (3,526 ± 1,433 μg/cm2) vs unpolished nails (2,661 ± 1,319 μg/cm2). In study 2, the mean cumulative tavaborole penetration was also numerically higher (statistical significance not assessed) through all nails that received polish vs unpolished nails. At day 15, mean ± SD cumulative tavaborole nail penetration was 1,179 ± 554 μg/cm2 through 4 coats of salon typical polish, 1,227 ± 974 μg/cm2 through 1 coat of salon typical polish, 1,493 ± 1,322 μg/cm2 through 2 coats of OTC typical polish, 1,428 ± 841 μg/cm2 through 1 coat of OTC typical polish, and 566 ± 318 μg/cm2 through unpolished nails.
CONCLUSION: Results from these in vitro studies demonstrated that tavaborole penetrated through human nails with up to 4 layers of nail polish.
J Drugs Dermatol. 2015;14(7):675-678.
A Comparative Review of the Efficacy and Tolerability of Retinoid-Containing Combination Regimens for the Treatment of Acne Vulgaris
James L. Campbell Jr. MD MS| |
Bilateral Comparison Study of Pimecrolimus Cream 1% and a Ceramide-Hyaluronic Acid Emollient Foam in the Treatment of Patients With Atopic Dermatitis
Topical corticosteroids have been the mainstay of treatment for atopic dermatitis (AD) over the last decade, especially in the setting of acute flares. However, heavy and prolonged use of topical corticosteroid is undesirable as it is associated with side effects such as, skin atrophy, telangiectasia, striae, steroid-induced dermatoses, rosacea, acne exacerbation, and in some severe and rare cases, systemic effects such as hypothalamic-pituitary-adrenal axis suppression, growth retardation and ocular problems. Non-steroidal antinflammatory agents specific for the treatment of AD (topical calcineurin inhibitors, or TCIs) are now available and they are a viable alternative to topical corticosteroids in treating dermatitis of the face, neck, eyelids, and intertriginous areas where there is a greater risk of the steroid-induced side effects. More recently, medical device emollients have entered the marketplace. These medical devices provide, but are not limited to, anti-oxidant, anti-protease, anti-inflammatory activity, and aid in restoring the natural balance of lipids, which is one of the causes of the epidermal abnormalities seen with AD. The present study evaluated the short-term effectiveness and appeal of a non-steroidal medicated device foam as compared to pimecrolimus cream 1% in the treatment of AD within a wide age group of subjects with active disease at baseline. In this study, both pimecrolimus and the medical device foam exhibited efficacy in mild-to-moderate AD. Primary efficacy was measured by IGA. After four weeks of treatment with the medical device foam, 82% of target lesions were scored "clear" (0) or "almost clear" (1) compared to 71% of target lesions under the pimecrolimus arm. This study confirmed that pimecrolimus cream 1% and the medical device foam work well in the treatment of AD in both adults and children with no associated adverse effects.
J Drugs Dermatol. 2011;10(6):666-672.
Evaluation of the Chemopreventative Effects of ALA PDT in Patients With Multiple Actinic Keratoses and a History of Skin Cancer
Objective: To evaluate the time to development of new non-melanoma skin cancers (NMSC) within one year of ALA-PDT treatment in immunocompetent patients with AK and a history of skin cancer.
Methods and Materials: One hundred forty anatomic sites in 114 patients were treated with topical ALA for a 1 to 3 hour incubation period followed by photodynamic therapy (PDT) with a blue light. All new NMSCs within the treatment areas were recorded over a 1-year observational period.
Results: Eighty-three anatomic sites (59%) did not develop new skin cancers within 1 year. Additionally, 92%, 78%, and 64% of anatomic sites were free of new skin cancers at 3, 6, and 9 months after treatment was initiated. Although approximately 41% of patients treated on both the scalp and face developed new skin cancers within 1 year of treatment, the average time to develop skin cancer was longer for the face (7.09 months) than for the scalp (5.34 months).
Conclusion: In patients with a history of NMSC and multiple AKs, ALA PDT may be a valuable option for the prevention and delay of new NMSCs.
J Drugs Dermatol. 2012;11(5):593-597.
Current Understanding of Seborrheic Keratosis: Prevalence, Etiology, Clinical Presentation, Diagnosis, and Management
J. Mark Jackson MD FAAD,a Andrew Alexis FAAD MPH FAAD,b Brian Berman MD PhD FAAD,c Diane S. Berson MD FAAD,d Susan Taylor MD FAAD,e Jonathan S. Weiss MD FAADf| |
J Drugs Dermatol. 2015;14(10):1119-1125.
Surgical Corner: A Prospective Randomized Evaluation of Cyanoacrylate Glue Devices in the Closure of Surgical Wounds
Joseph Maloney BA,a Gary S. Rogers MD,b,c and Mitesh Kapadia MD PhDd| |
OBJECTIVE: To compare the use of two currently marketed medical adhesives; LiquiBand® Flow Control and High Viscosity Dermabond ™ for the topical closure of surgical incisions.
METHODS: In a prospective blinded manner, subjects were randomly assigned LiquiBand® or DermabondTM for topical closure of a surgical incision. Variables compared included ease of use, time taken to close wound, subject and surgeon satisfaction with device and wound closure, cosmetic outcome at 90 days, and complication rates.
RESULTS: Use of both devices resulted in effective wound closure with similar high levels of cosmesis subject and surgeon satisfaction, with only minor complications reported. There was no statistically significant difference between the devices for all the parameters studied, with the exception that the Liquiband device was found to significantly reduce the amount of time required for closure.
CONCLUSION: As the two devices appear substantially equivalent in terms of key surgeon and patient variables, product cost should be the primary determinant in selection of the tissue glue device.
J Drugs Dermatol. 2013;12(7):810-814.
Vic A. Narurkar MD,a Sabrina G. Fabi MD FAAD FAACS,b Vivian W. Bucay MD FAAD,c Ruth Tedaldi MD,d Jeanine B. Downie MD,e Joshua A. Zeichner MD,f Kimberly Butterwick MD,g Amy Taub MD,h Kuniko Kadoya PhD,i Elizabeth T. Makino BS MBA CCRA,i Rahul C. Mehta PhD,i and Virginia L. Vega PhDi| |
SkinMedica’s HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles.
Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.
J Drugs Dermatol. 2016;15(1 Suppl 2):s24-s37.
Isabela T. Wieczorek MD,a Brian P. Hibler BS,b and Anthony M. Rossi MDc| |
J Drugs Dermatol. 2015;14(9):1043-1051.
Rachel Seidel,b.c Nicolette Lavi,c and Lisa Chipps MD MSa,c| |
CASE: A woman in her second trimester presented with an intensely pruritic vesiculobullous rash diagnosed as PG. She was started on prednisone and gradually tapered to an appropriate maintenance dose until her uncomplicated delivery of a full-term healthy newborn.
CONCLUSION: Proper management of PG requires a suitable pharmacotherapy regimen, close observation, and collaboration with a multi-disciplinary treatment team. These steps are crucial to reduce maternal morbidity, lessen fetal risk, and adequately prepare for the possibility of unfavorable obstetric outcomes.
J Drugs Dermatol. 2015;14(8):904-907.
Derek Ho BSa and Jared Jagdeo MD MSa, b, c| |
OBJECTIVE: Evaluate the biological properties, including biochemical, biophysical and rheological, of this new 20 mg/ml HA dermal filler and discuss the importance of these properties in clinical applications.
METHODS AND MATERIALS: A systematic search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch, Pascal, HCAPlus, IPA, and Dissertation Abstracts with key term “Voluma.” Four articles on the biological properties of this new 20 mg/ ml HA dermal filler were suitable for inclusion in this review.
RESULTS: Biological analysis of elasticity and viscosity values of this new 20 mg/ml HA dermal filler demonstrated intermediate properties in three studies and high in one study compared to other HA dermal fillers. This 20 mg/ml HA dermal filler retained the highest elasticity and viscosity values at temperature of 37°C. Histology demonstrated that this 20 mg/ml HA dermal filler has an intermediate pattern of distribution within the superficial and deep reticular dermis.
CONCLUSION: This 20 mg/ml HA dermal filler demonstrated volumizing ability, and maintaining viscosity and free-flowing characteristics for easy injection, tissue lifting, and molding. We hope future research incorporates biological properties analysis of this HA dermal filler in clinical trials.
J Drugs Dermatol. 2015;14(1):50-54.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.
Tina Bhutani MD and John Koo MD| |
J Drugs Dermatol. 2011;10(11):1292-1298.
Claudia Hossain BS,a Dennis A. Porto MD,b Iltefat Hamzavi MD,b and Henry W. Lim MDb| |
J Drugs Dermatol. 2016;15(4):384-387.
Evaluation of Clinical Improvement in Acne Scars and Active Acne in Patients Treated With the 1540-nm Non-Ablative Fractional Laser
María José Isarría MD, Paloma Cornejo MD, Estefanía Muñoz BSc, Josefina Royo de la Torre MD, Javier Moreno Moraga MD| |
Introduction. Acne is a characteristic condition of puberty; however, adults who continue to have acne outbreaks frequently attend dermatology clinics. Two conditions—active acne and residual scarring—often co-occur in these patients. The objective of the present study was to evaluate the improvement in scarring and active acne after treatment with a 1540-nm erbium: glass fractional laser.
Material and Methods. The authors treated 20 patients with acne and scarring. Each patient received panfacial treatment in four sessions with a 1-month interval between sessions. Patients, the treating physician and a blinded observer evaluated the results in four areas: improvement in scars, improvement in pores, improvement in acne, and improvement in sebum secretion. Improvements were graded using the Global Aesthetic Improvement Scale. The evaluation was made 12 weeks after treatment finished.
Results. Patients presented an improvement in both acne and scars. In 80 percent of cases, patients felt that the appearance of the scars had improved, and the improvement was classified as very much improved in 40 percent. In 85 percent of cases, patients felt that active acne had improved, and the improvement was classified as very much improved in 45 percent. Pore size was evaluated as improved by 75 percent of patients. Sebum secretion improved in 80 percent of cases.
Conclusion. A 1540-nm non-ablative fractional laser provides effective treatment of acne scars. Patient satisfaction is high and active acne lesions improve significantly. Treatment of this mixed condition (scarring and active acne) with a single device is reliable, with a favorable safety profile and a high degree of patient acceptance.
J Drugs Dermatol. 2011;10(8):916-921.
Joy Makdisi BS and Adam Friedman MD FAAD| |
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| |
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.
A Double-Blind, Randomized Clinical Trial of 20% Alpha/Poly Hydroxy Acid Cream to Reduce Scaling of Lesions Associated With Moderate, Chronic Plaque Psoriasis
Kristie L. Akamine MD,a Cheryl J. Gustafson MD,a Brad A. Yentzer MD,a Brenda L. Edison BA,d Barbara A. Green RPh MS,d Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: To evaluate the therapeutic efficacy of topical 20% alpha-hydroxy/polyhydroxy acid versus standard salicylic acid to reduce scaling in patients with moderate, chronic psoriasis.
METHODS: Twenty-five subjects with moderate, chronic psoriasis were enrolled in a 2-week, double-blind, left-right, randomized, bilateral comparison clinical trial to compare the efficacy of 20% alpha-hydroxy/polyhydroxy acid emollient versus 6% salicylic acid cream and 24 were randomized/completed. Clinical evaluations to assess the severity of psoriasis and scaling were performed using a 6-point scale prior to treatment, as well as following 1 and 2 weeks of therapy.
RESULTS: Twenty-four participants completed the study. Both 20% alpha-hydroxy/polyhydroxy acid emollient and 6% salicylic acid cream were efficacious in reducing scale of psoriatic lesions. The topical 20% alpha-hydroxy/polyhydroxyacid reduced scaling at a faster rate; however, following 2 weeks of treatment the efficacy of both products were relatively the same.
CONCLUSION: 20% alpha-hydroxy/polyhydroxyacid is as efficacious as salicylic acid in regards to the de-scaling of psoriatic plaques. Additionally, 20% alpha-hydroxy/polyhydroxyacid cream may yield quicker results and less toxicity than salicylic acid.
J Drugs Dermatol. 2013;12(8):855-859.
A 12-Month, Prospective, Evaluator-Blinded Study of Small Gel Particle Hyaluronic Acid Filler in the Correction of Temporal Fossa Volume Loss
Amir Moradi MD,a Azadeh Shirazi MD,b and Jeanette Moradi CRCa| |
STUDY DESIGN: This is a US Food and Drug Administration-approved, blinded, prospective, single-center, open-label trial enrolling 20 subjects undergoing subcutaneous injection of SGP-HA for rejuvenation of the temples. Primary outcomes were measured using a standardized grading system—the Hollowness Severity Rating Scale (HSRS)—at each visit by the treating investigator, a blinded physician assessment of randomized photos using the HSRS, and patient questionnaires over a 12-month period. AEs were monitored by the investigator and via patient diaries.
RESULTS: At weeks 4, 12, and 24, and month 12, all graders (ie, investigator, blinded physician assessor, and patients) reported improvement overall in hollowness. At baseline, temporal fossa hollowness was measured as moderate to severe. At week 4 to month 12, temporal fossa was graded at none or only mild hollowness. No touch-ups were necessary at week 4 on all subjects. All AEs were mild or moderate and resolved within 2 weeks.
CONCLUSION: Our study demonstrates clinically significant efficacy and safety in the use of Restylane for temple augmentation and, thus, facial rejuventation.
J Drugs Dermatol. 2013;12(4):470-475.
A Randomized, Double-Blind, Controlled Comparative Trial of the Anti-Aging Properties of Non-Prescription Tri-Retinol 1.1% vs. Prescription Tretinoin 0.025%
Elizabeth T. Ho BS,a Nathan S. Trookman MD,b Brian R. Sperber MD PhD,b Ronald L. Rizer PhD,c Ralph Spindler PhD,d Sujatha Sonti PhD,a Vincent Gotz MS Pharm,e Rahul Mehta PhDa| |
J Drugs Dermatol. 2012;11(1):64-69.
Single-Center, Open-Label Study of a Proprietary Topical 0.5% Salicylic Acid-Based Treatment Regimen Containing Sandalwood Oil in Adolescents and Adults With Mild to Moderate Acne
Methods: The investigational regimen consisted of a foaming cleanser, an acne serum, a spot treatment, and a mask. Patients applied the treatment regimen as directed for 8 weeks. The primary ef!cacy measure was the percentage of patients assessed as improved, much improved, or very much improved according to the Global Aesthetic Improvement Scale (GAIS) ratings at week 8. Severity was rated using the Evaluato's Global Severity Scores (EGSS) at baseline and weeks 2, 4, and 8. Tolerability was assessed at baseline and weeks 2, 4, and 8 by asking patients to rate the severity of itching, scaling, erythema, burning, dryness, and stinging. Patients were also asked to complete an acne questionnaire.
Results: 89.4% (42/47) met the primary end point determined by the GAIS of improved (66%), much improved (19%), or very much improved (4%). Notable reductions in lesion counts were observed in patients with more severe or in"amed lesions. Tolerability was queried at all visits. No itching, scaling, or erythema was reported after initial application. Symptoms of intolerability peaked at week 2; however, most events were mild to moderate and were typically reported with use of the mask component. Intolerance decreased by week 4 and by week 8. The treatment regimen was well tolerated by patients.
Conclusions: Results from this study support the use of a proprietary investigational regimen in patients with mild to moderate acne and warrant further investigation to determine whether longer-term therapy (ie, beyond 8 weeks) results in enhanced efficacy with minimal side effects, leading to continued patient compliance and skin improvement.
J Drugs Dermatol. 2012;11(12):1403-1408.
M. Shane Hamman MD,a Sabrina G. Fabi MD,b and Mitchel P. Goldman MDb
aDepartment of Dermatology, University of California San Diego, San Diego, CAbGoldman Butterwick Fitzpatrick Groff & Fabi, Cosmetic Laser Dermatology, San Diego, CA
Objective: To report and compare the efficacy and safety of HA used to treat tear trough deformities with two different injection techniques.
Materials and Methods: This is a retrospective, single-center study of 81 patients comparing the two injection techniques used for the treatment of tear trough deformities from 2003 to 2011. Hyaluronic acid was administered either in a single depot in the nasojugal groove and massaged into position or in multiple small aliquots along the inferior orbital rim and massaged into position. Patient satisfaction and the incidence of adverse reactions were evaluated.
Results: Of the 194 patients treated during the study period, 81 (42%) were successfully contacted. The overall patient satisfaction with the correction was similar for both techniques. Two patients treated with a single depot of HA were later given hyaluronidase, but otherwise, there was no statistically significant difference in the incidence and severity of side effects.
Conclusions: We describe and compare an alternative technique for the correction of tear trough deformity using a single deposition of HA in the nasojugal groove with favorable outcomes.
J Drugs Dermatol. 2012;11(12):e80-e84.
Hilary E. Baldwin MD,a Neal D. Bhatia MD,b Adam Friedman MD,c Richard Martin Eng,d and Sophie Seité PhD e| |
Aimee Krausz BA and Adam J. Friedman MD| |
J Drugs Dermatol. 2012;11(9):1089-1093.
A Randomized, Double-Blind Phase 4 Study of the Efficacy and Safety of Ethanol-Free Clobetasol Propionate Foam, 0.05%, vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis
Leon H. Kircik MD,a-c William J. Eastman MD,d and Jennifer Gwazdauskas MBAe| |
OBJECTIVES: To demonstrate superior efficacy, similar safety, and superior QOL outcomes in subjects with moderate to severe chronic hand dermatitis following treatment with clobetasol propionate foam, 0.05%, compared with vehicle foam.
METHODS: In this randomized, double-blind, vehicle-controlled, parallel-group, multicenter study (ClinicalTrials.gov identifier NCT01323673), subjects aged 12 years and older with moderate to severe chronic hand dermatitis and an Investigator's Static Global Assessment (ISGA) score of 3 or 4 at baseline were randomized 1:1 to receive clobetasol propionate foam, 0.05%, or vehicle foam, twice daily over 15 days. The primary end point was the proportion of subjects who achieved treatment success, defined as improvement from baseline of ≥2 ISGA grades for the target hand at day 15.
RESULTS: In total, 125 subjects were enrolled: 62 subjects were randomized to the clobetasol propionate foam group and 63 subjects were randomized to the vehicle foam group. The proportion of subjects with treatment success at day 15 did not differ significantly between treatment groups. Adverse events (AEs) were reported in 18% of subjects in the clobetasol propionate foam group and 8% of subjects in the vehicle foam group. No serious AEs, AEs resulting in discontinuation of study product, or severe AEs were reported in the clobetasol propionate foam group.
CONCLUSIONS: Clobetasol propionate foam, 0.05%, was not significantly more efficacious than vehicle foam at improving chronic hand dermatitis on investigator-assessed end points. Emollient properties of the study product vehicle may be a confounder in the study.
J Drugs Dermatol. 2013;12(3):328-334.
Aimee Krausz,a Holly Gunn MD,b and Adam Friedman MD FAADa,c| |
J Drugs Dermatol. 2014;13(8):937-943.
A Phase 2, Randomized, Controlled, Dose-Ranging Study Evaluating Crisaborole Topical Ointment, 0.5% and 2% in Adolescents With Mild to Moderate Atopic Dermatitis
Linda F. Stein Gold MD,a Lynda Spelman MBBS FACD,b Mary C. Spellman MD,c Matilda H. Hughes CCRA,d and Lee T. Zane MDd| |
METHODS: In this multicenter, randomized, double-blind, dose-ranging, phase 2 study, adolescent patients 12 to 17 years of age with mild to moderate AD and 2 distinct target AD lesions were randomized to once-daily (QD) or twice-daily (BID) treatment with crisaborole topical ointment. For each patient, 2 target lesions were randomized to receive 29 days of treatment with 0.5% or 2% crisaborole topical ointment. The primary endpoint was change from baseline in AD severity index (ADSI) score for each lesion. Exploratory efficacy endpoints and safety were also assessed.
RESULTS: A total of 86 patients were enrolled and received crisaborole topical ointment 0.5% or 2% QD (n=44) or BID (n=42). All dosing regimens produced dose-related improvements in ADSI as well as in all 5 component signs and symptoms of AD (erythema, excoriation, exudation, lichenification, and pruritus). The greatest improvements were consistently observed with crisaborole topical ointment, 2% applied BID. With this regimen, ADSI improved from baseline by 71%, and total or partial clearance of target lesions (ADSI ≤2) was achieved by 62% of patients after 29 days of treatment. Both doses of crisaborole topical ointment were well tolerated; mild application site reactions were the only treatment-related adverse events (QD, n=3; BID, n=1).
CONCLUSION: These results provide preliminary evidence of the efficacy and safety of crisaborole topical ointment, 2% applied topically BID in adolescents with mild to moderate AD.
J Drugs Dermatol. 2015;14(12):1394-1399.
Adam J. Friedman MD FAAD,a Erika C. von Grote PhD,b Matthew H. Meckfessel PhDb| |
J Drugs Dermatol. 2016;15(5):633-639.
Leon H. Kircik, MD| |
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.
Halobetasol Propionate Lotion, 0.05% Provides Superior Hydration Compared to Halobetasol Propionate Cream, 0.05% in a Double-Blinded Study of Occlusivity and Hydration
Gary Grove PhD,a Charles Zerweck PhD,a Tim Houser MS,a Anthony Andrasfay BS,b Bob Gauthier MS,b Charles Holland PhD,b and Daniel Piacquadio MDb| |
J Drugs Dermatol. 2017;16(2):140-144.
Evaluation of the Physician Global Assessment and Body Surface Area Composite Tool for Assessing Psoriasis Response to Apremilast Therapy: Results from ESTEEM 1 and ESTEEM 2
Kristina C. Duffin MD MS,a Kim A. Papp MD PhD,b Jerry Bagel MD,c Eugenia Levi PharmD BCPS,d Rongdean Chen PhD,d and Alice B. Gottlieb MD PhDe| |
J Drugs Dermatol. 2017;16(2):147-153.
Hernan Pinto MDa and Luis G. Garrido MDb,c| |
J Drugs Dermatol. 2013;12(3):322-326.
Subhash J. Saxena PhD,a Deysi Duque MS,b and Michael J. Schirripa PhDb| |
METHODS: 85 adult females ages 35-65 with Fitzpatrick skin types I through IV applied the test neck cream twice daily for a 3-month study period. Screening was conducted at Baseline, 2, 30, 60, and 90 days via a virtual trial. Subjects rated satisfaction in each of 4 anti-aging categories including hydration, texture, appearance of wrinkles, and appearance of laxity as well as three product attributes including application, feel, and smell.
RESULTS: Improvement was statistically significant for all measured categories (hydration, texture, appearance of wrinkles, and appearance of laxity) with 94% of study subjects noting improvement in one or more of the measured categories. Further, the quantity of “Satisfied” and “Highly Satisfied” assessments increased 8-fold from baseline with a 94x increase in the quantity of “Highly Satisfied” assessments.
DISCUSSION: The results demonstrate the product’s rapid and continuing ability to improve the self-perceived signs of aging in the neck area including improvement in skin texture on the neck and a reduction in the appearance of wrinkles and laxity along the jawline. Future studies are recommended to determine the primary action mechanisms and to assess the degree of improvement by blinded physician assessment.
J Drugs Dermatol. 2015;14(9):997-1002.
The Treatment of Inflammatory Facial Dermatoses With Topical Corticosteroids:Focus on Clocortolone Pivalate 0.1% Cream
Methods: Clocortolone pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin.
Results: Treatment with clocortolone pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis).
Conclusion: Clocortolone pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.
J Drugs Dermatol. 2012;11(10):1194-1198.
Anjana Ray PhD,a,* Breanne Mordorski BA,b,* Angelo Landriscina BA,b Jamie Rosen BA,b Joshua Nosanchuk MD,a,c and Adam Friedman MDd| |
J Drugs Dermatol. 2016;15(7):836-840.
Malignancy Arising Within Cutaneous Tattoos: Case of Dermatofibrosarcoma Protuberans and Review of Literature
Kavitha K. Reddy MD,a C. William Hanke MD, MPH,b Emily P. Tierney MDa,b| |
Background. Dermatofibrosarcoma protuberans (DFSP) is an uncommon tumor of the skin with high rates of local recurrence. Several
reports describe a frequent history of local trauma. In one prior case, a DFSP arising in a tattoo site has been reported. Mohs micrographic surgery (MMS) has been used successfully for treatment.
Objective. To present a case of dermatofibrosarcoma protuberans arising in the site of a prior and current tattoo, and treated with Mohs micrographic surgery.
Methods. We present findings of a case of a DFSP arising in a tattoo and a review of Medline literature on the association between tattoos and cutaneous malignancy, and treatment of DFSP with MMS.
Results. Review of the literature confirms multiple reports of DFSP arising in sites of local trauma, as well as malignancies arising in sites of tattoos. The recurrence rate for MMS treatment of DFSP (0-6.6%) was found to be significantly lower than that for patients treated with wide local excision (13% to 95%).
Conclusions. DFSP should be considered in the differential diagnosis of neoplasms arising within areas of tattoos. Sites of local trauma and tattoos may show predilection for benign and malignant changes and should be evaluated during regular skin exams. Review of the literature confirms MMS is an ideal treatment modality for DFSP as the tumor often extends far beyond clinical margins.
J Drugs Dermatol. 2011;10(8):910-915.
Patrick Micheels MD,a Stéphanie Besse MD,b and Didier Sarrazin MDc| |
METHOD: The “resistance traction test” and “cohesiveness test” were conducted according to standard methods. Juvéderm® Volbella™ gel was injected into the buttock area, both in the superficial reticular and mid-reticular dermis. Tissue samples were analyzed at days 0, 15, and 90 by histology and immunohistochemistry, and visualized using electron microscopy. For Volbella™ gel, the same ultrasound devices as previously used were employed.
RESULTS: Prior to staining, Volbella™ gel presented resistance to spreading, suggesting a certain degree of cohesiveness. When smeared between two slides and following toluidine blue staining, the gel was visible through the microscope in the form of multiple tiny discrete particles, possibly resulting from gel desintegration. At 1/3 dilution with saline serum, Volbella™ gel disintegrated into several lumps, whereas at 1/1 dilution, Volbella gel appeared more cohesive. Yet when adding one drop 70% ethanol, the gel resembled a poorly defined magma, with numerous small lumps. On ultrasound, Volbella™ gel was found to leak in the hypodermis. On histological analysis, Volbella™ gel was visible as pools of variables sizes, particularly in the superficial and mid-reticular dermis, but also hypodermis.
CONCLUSION: Juvéderm Volbella™ gel appears to be a gel characterized by low-medium cohesiveness. The study findings, combined with our previous work, show that HA fillers using Vycross™ technology are not ideally suited for superficial use, unlike HA fillers using CPM technology™.
J Drugs Dermatol. 2016;15(9):1092-1098.
J Drugs Dermatol. 2012;11(9):1081-1088.
Comparative Effects of Sunscreens Alone vs Sunscreens Plus DNA Repair Enzymes in Patients With Actinic Keratosis: Clinical and Molecular Findings from a 6-Month, Randomized, Clinical Study
Mauro Carducci MD,a Paolo Sergio Pavone MD,b Giuseppe De Marco MD,a Silvia Lovati MD,b
Velimir Altabas MD,d Karmela Altabas MD,d and Enzo Emanuele MDc
J Drugs Dermatol. 2015;14(9):986-990.
Linda Stein Gold MD| |
J Drugs Dermatol. 2015;14(6):567-572.
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.
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.
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.
The Active Natural Anti-Oxidant Properties of Chamomile, Milk Thistle, and Halophilic Bacterial Components in Human Skin In Vitro
Andrew Mamalis BS,a, b Duc-Huy Nguyen,a Neil Brody MD PhD,c and Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2013;12(7):780-784.
Dina Coronado BS, Tejal Merchant MPharm, Sanjay Chanda PhD, and Lee T. Zane MD| |
J Drugs Dermatol. 2015;14(6):609-614.
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.
DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray, Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis
Joseph F. Fowler Jr. MD,a Adelaide A. Hebert MD,b Jeffrey Sugarman MD PhDc| |
OBJECTIVE: To compare the efficacy and safety of medium potency DFD-01 with super potent augmented betamethasone dipropionate 0.05% lotion (Diprolene) for the topical treatment of moderate plaque psoriasis.
METHODS: Adults with moderate plaque psoriasis (Investigator Global Assessment [IGA]=3; 10–20% BSA) were randomized 2:1:1 to DFD-01, Diprolene, or Vehicle. Products were applied twice daily to affected areas for 14 days. Treatment success was defined as IGA=0 or 1 and ≥2-grade improvement from baseline. IGA and target lesion Total Sign Score (TSS; sum of erythema, scaling, and plaque elevation scores) were assessed at baseline and at days 4, 8, and 15. Adverse events (AEs) were recorded.
RESULTS: 351 subjects with moderate psoriasis were randomized to DFD-01 (n=174), Diprolene (n=90), or Vehicle (n=87). Mean BSA was 13–14%. Treatment success was achieved in 19.0% DFD-01, 18.9% Diprolene, and 2.3% Vehicle (P<0.001 DFD-01 vs Vehicle) at day 15. Treatment success at day 8 was 10% DFD-01, 6.7% Diprolene, and 1.2% Vehicle (P=0.003 DFD-01 vs Vehicle). TSS was significantly reduced with DFD-01 compared with Vehicle at days 4, 8, and 15 (P≤0.006) and compared with Diprolene at day 4 (P=0.010). DFD-01 relieved signs of erythema and scaling earlier than Diprolene or Vehicle, showing significant improvements on day 4 (P≤0.048). All products were well tolerated. Significantly more burning/stinging was reported with Diprolene than DFD-01 (13.6% vs 4.1%, P=0.006).
CONCLUSION: Medium potency DFD-01 was efficacious for the treatment of moderate psoriasis. DFD-01 demonstrated similar efficacy to super potent Diprolene lotion. Results at 4 and 8 days indicate that DFD-01 shows early improvement in some subjects. DFD-01 was well tolerated and had an excellent safety profile.
J Drugs Dermatol. 2016;15(2):154-162.
Richard L. Gallo MD PhD,a Vivian W. Bucay MD,b Ava T. Shamban MD,c Janice Lima-Maribona DO,d Amy B.
Lewis MD,e Cherie M. Ditre MD,f Flor A. Mayoral MD,g Michael H. Gold MDh
J Drugs Dermatol. 2015;14(7):669-674.
Richard R. Winkelmann DO,a James Del Rosso DO FAOCD,b and Darrell S. Rigel MD MSc| |
J Drugs Dermatol. 2015;14(3):254-259.
David Stocks BSc (Hons),a Hema Sundaram MD,b Jason Michaels MD,c Manzer J. Durrani PhD,d Mitchell S. Wortzman PhD, d Diane B. Nelson BSN MPHd| |
Background: Hyaluronic acid (HA) gels are commonly injected into the skin to lift rhytides and to improve facial appearance. The different processes used in their manufacture and formulation yield products with unique physical characteristics that play an important role in predicting their clinical performance.
Objective: The following rheologic evaluation was performed to objectively measure the physical characteristics of HA dermal filler products derived from similar bacterial sources and containing the same butanediol diglycidyl ether cross-linker, but formulated using different manufacturing techniques. The objective of this study was to evaluate the physical characteristics of two distinct families of HA products, thereby providing clinicians with a greater understanding of these products' attributes and the ability to optimize their use in the treatment of patients seeking facial rejuvenation.
Materials and Methods: The physical properties of commercially-available dermal fillers containing HA were evaluated using rheologic testing methods under clinically-relevant conditions. Additionally, light microscopy was used to assess the particulate nature of each product.
Results: The gels tested demonstrated a broad range of elasticity, firmness and viscosity. Light microscopy confirmed the particulate nature of each product and revealed HA particles of varying size and distribution.
Conclusion: This rheologic evaluation demonstrates that differences exist among the HA products tested including gel elasticity, viscosity, and the range and distribution of gel particle sizes. Understanding the distinct physical characteristics of different HA dermal fillers and how these characteristics may predict their clinical behavior can assist clinicians in achieving the desired results in patients seeking facial rejuvenation.
J Drugs Dermatol. 2011;10(9):974-980.
Benzoyl Peroxide Development, Pharmacology, Formulation and Clinical Uses in Topical Fixed-combinations
Julie C. Harper MD| |
Alison Harvey PhD MS and Tu T. Huynh PhD| |
J Drugs Dermatol. 2014;13(4):459-463.
Improved Neocollagenesis and Skin Mechanical Properties After Injection of Diluted Calcium Hydroxylapatite in the Neck and Décolletage:A Pilot Study
Yana Alexandrovna Yutskovskaya MD PhDa and Evgeniya Alexandrovna Kogan MD PhDb| |
Ted Rosen M.D.| |
Within a relatively short period of time after the first antimicrobial drugs were introduced, bacteria began exhibiting varying degrees of resistance. The excessive use (and abuse) of antibiotics in agriculture, and in both human and veterinary medicine, has played a critical causative role in the development of antibiotic resistance, which is now recognized as a global public health threat. Increasing concern over this issue should impact the practice of cutaneous medicine and surgery, as dermatologists can easily adopt new healthcare delivery patterns that might reduce the development of antibiotic resistance and still achieve acceptable treatment outcomes. Dermatologists should seriously consider any and all alternative therapies before committing to an extended course of antibiotic therapy for disease entities that are almost certainly not infectious. Conversely, dermatologists should carefully and closely adhere to dosage and duration recommendations when using antibiotics to treat a bona fide infectious disorder.
J Drugs Dermatol.2011;10(7):724-733.
Efficacy and Tolerability Assessment of a Topical Formulation Containing Copper Sulfate and Hypericum perforatum on Patients With Herpes Skin Lesions: A Comparative, Randomized Controlled Trial
Objectives: The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use.
Methods: A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14.
Results: Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group.
Conclusions: The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.
J Drugs Dermatol. 2012;11(2):209-215.
Eliot F. Battle Jr. MD| |
Laser hair removal, previously contraindicated in patients with ethnically dark (phototypes IV-VI) or sun-tanned skin, is now recognized as a safe and effective method of permanent hair reduction in all patients. Longer wavelengths, conservative fluences, longer pulse durations and appropriate cooling methods are necessary to minimize untoward side effects and maximize efficacy. The longer wavelength Nd:YAG laser is considered safest in treating darker skin of color. An added benefit of laser epilation is that side effects of conventional hair removal such as pseudo-folliculitis barbae and post inflammatory dyspigmentation, more commonly seen in skin of color, may also respond favorably to the laser, thus increasing the potential for patient satisfaction.
J Drugs Dermatol. 2011;10(11):1235-1239.
A Novel Microgel Complex Delivers Acne Medicine Deep into Follicles While Demonstrating High Patient Tolerance
Jeff Wu PhD, Jeannette Chantalat MBA, Jue-Chen Liu PhD| |
J Drugs Dermatol. 2015;14(2):176-182.
A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females
Romain Roure MS,a Virginie Nollent Pharm.D,a Liliane Dayan MD,b Etienne Camel Pharm.D,c
Christiane Bertin MSa
J Drugs Dermatol. 2016;15(6):750-758.
Anthony Rossi MD,a,d Rebecca Lu MD,a Melissa K. Frey MD,d Takako Kubota MD,c
Lauren A. Smith MD,e and Maritza Perez MDa,b
OBJECTIVE: We examined the use of the 300 microsecond 1064 nanometer (nm) Nd:YAG laser for the treatment keloids in patients with skin types ranging from Fitzpatrick I through VI.
METHODS & MATERIALS: A retrospective analysis of treatment efficacy was conducted on 44 patients with keloids. Three separate treatment groups were compared. The groups consisted of: a “control group” in which the whole keloid was only treated with intralesional corticosteroid (triamcinolone 10mg/cc) (16 patients); a “laser only” group in which the patient’s keloid was only treated with the 1064nm Nd:YAG laser at a fluency of 13 to 18 Joules / centimeter2 (J/cm2), a fixed pulse duration of 300 microseconds, 5mm spot size, and a total of 2000 pulses (14 patients); and a “combination group” that received both the aforementioned laser therapy and adjuvant intralesional triamcinolone (14 patients).
RESULTS: Patients in the "combination group" treated with the 300 microsecond 1064nm Nd:YAG laser therapy plus intralesional corticosteroid and the "laser only" group both were observed to have durable clinical reduction in the thickness and erythema of the keloids. These results were shown to be superior to the "control group" whom were only treated with intralesional corticosteroids. Only mild and transient post treatment erythema was noted as an adverse effect.
STATISTICAL ANALYSIS: Data analysis was performed using IBM SPSS Statistics 19.0.0 (Armonk, NY). In order to assess the statistical significance of differences in keloid improvement among the three treatment groups, The Kruskal-Wallis test (non-parametric ANOVA test) was applied. The level of statistical significance was set at P<0.05. A statistically significant difference in keloid improvement was appreciated between treatment groups (P<0.0001).
LIMITATIONS: A small sample size and the retrospective nature of the analysis are limitations to the study.
CONCLUSION: The 300 microsecond 1064nm Nd:YAG laser proved effective in improving the clinical appearance of keloids. We recommended this laser protocol in conjunction with intralesional corticosteroids as a treatment option for patients with keloids, especially in the skin of color population. The 1064nm Nd:YAG laser did not show post inflammatory hyperpigmentation nor hypopigmenatation, which are concerns for skin types IV to VI, and therefore is a suitable option for such patients.
J Drugs Dermatol. 2013;12(11):1256-1262.
Brandon L. Adler BA and Adam J. Friedman MD| |
Catherine N. Tchanque-Fossuo MD MS,a,b,* Derek Ho BS,a,b,* Sara E. Dahle DPM MPH,b,c Eugene Koo MS,a R. Rivkah Isseroff MD,a,b and Jared Jagdeo MD MSa,b,d| |
OBJECTIVE: To review published clinical experiences (case series and case reports) using LLLT for treatment of DFU, and provide evidence-based recommendations and future directions on the potential of LLLT as a therapeutic modality for DFU.
METHODS AND MATERIALS: On January 16, 2016 we searched the published literature using databases: PubMed, EMBASE, CINAHL, and Web of Science with key terms: “diabetic foot” AND (“low level laser therapy” OR “low level light therapy” OR “LLLT” OR “light emitting diode” OR “phototherapy” OR “laser”).
RESULTS: After screening of titles, abstracts and/or full-text, 7 original articles were suitable in our review. Our review contains 5 case series and 2 case reports that evaluated LLLT for treatment of DFU, and all reviewed studies have shown positive improvement of DFU using LLLT with no adverse events, albeit with limitations that may be minimized with future RCTs.
CONCLUSIONS: LLLT is an emerging and promising treatment modality to current alternatives that are costly and have shown limited success. Based upon the published evidence, we envision additional research may allow for stronger recommendation with LLLT for treatment of DFU.
J Drugs Dermatol. 2016;15(7):843-848.
Jordan Fabrikant DO,a Khasha Touloei DO,b and Stuart M. Brown MDc| |
J Drugs Dermatol. 2013;12(7):775-779.
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.
Ellinor R. Quay MD,a Yunyoung C. Chang MD,a and Emmy Graber MD MBAb| |
As the market for South Korean skin care products grows in the U.S. and worldwide, consumers will increasingly seek advice from dermatologists regarding their efficacy. In this paper, the evidence behind the anti-aging and skin whitening activity of ingredients in the most popular South Korean skin care products was reviewed and critically evaluated. Industry profit data from Euromonitor was obtained to identify the top cosmeceutical brands by retail value in South Korea. The top selling products and their ingredients were then identified from individual brand websites. A comprehensive literature search was conducted using Pubmed to identify and grade the anti-aging and whitening efficacy for nine popular ingredients: licorice, niacinamide, beta-glucan, snail mucus, ginkgo biloba, ginseng, green tea, pomegranate, and soy. Of the various ingredients reviewed, niacinamide, green tea, licorice, and soy have the most published data for anti-aging and whitening activity. Although the literature shows modest results, small sample sizes limit interpretation. High-level evidence to support the use of South Korean skin care products in anti-aging and skin whitening is lacking.
J Drugs Dermatol. 2017;16(4):358-364.
Samreen Z. Choudhry MD,a Neal Bhatia MD,b Roger Ceilley MD,c Firas Hougeir MD,d
Robert Lieberman MD,e Iltefat Hamzavi MD,a and Henry W. Lim MDa
J Drugs Dermatol. 2014;13(2):148-153.
Taurine Chloramine Inhibits NO and TNF-α Production in Zymosan Plus Interferon-γ Activated RAW 264.7 Cells
Bo Sook Kim,a In Soo Cho,b Seung Yong Park,c Georgia Schuller-Levis,d William Levis,e Eunkyue Parkd| |
Taurine is present abundantly in various tissues, especially in leukocytes embattled to foreign invaders such as microorganisms or oxidants. Taurine-chloramine (Tau-Cl) is produced from taurine at the site of inflammation via the myeoloperoxidase-halide pathway in leukocytes induced by oxidants and/or infectious materials. Previously, our data demonstrated that Tau-Cl inhibited nitric oxide (NO) production and TNF-α secretion induced by lipopolysaccharide (LPS), a Toll-like receptor 4 (TLR-4) ligand or lipoarabinomannan (LAM), a TLR-2 ligand plus interferon-γ (IFN-γ) in peritoneal macrophages or RAW 264.7 cells. Zymosan, a β-glucan of yeast cell wall, is a ligand for TLR-2 and dectin-1 and stimulates macrophages to produce proinflammatory mediators such as NO and TNF-α. Based on our previous data, we examined the effect of zymosan and IFN-γ induced production of NO and TNF-α in the absence or presence of Tau-Cl or taurine using RAW 264.7 cells. Production of NO and secretion of TNF-α is increased when zymosan is combined with IFN-γ. Tau-Cl inhibited production of NO and secretion of TNF-α in zymosan plus IFN-γ activated RAW 264.7 cells in a dose-dependent manner (99% vs. 48% using 0.8mM Tau-Cl). Taurine was without effect. Nitric oxide synthase protein (iNOS), induced by zymosan plus IFN-γ, was inhibited by Tau-Cl (0.8mM) as measured using western blot analysis. NOS mRNA was inhibited by Tau-Cl at four, eight and 16 hours post activation, but not at 24 hours. TNF-α mRNA was inhibited at four hours and eight hours, but not at 16 and 24 hours. These data suggest that expression of both iNOS and TNF-α mRNAs are inhibited by treatment with Tau-Cl within four and eight hours, but not at later time points. Transient suppression of activation of RAW 264.7 cells induced by zymosan may play a critical physiological role for taurine in protecting against tissue injury from initial overt inflammation. This study indicates that tropical treatment of taurine may ameliorate inflammatory dermatoses caused by an environmental yeast or abnormal immune function.
J Drugs Dermatol. 2011;10(6):659-665.
Efficacy of Cream-Based Novel Formulations of Hyaluronic Acid of Different Molecular Weights in Anti-Wrinkle Treatment
Tatjana Pavicic,b Gerd G. Gauglitz,b Peter Lersch,a Khadija Schwach-Abdellaoui,c Birgitte Malle,c Hans Christian Korting,b Mike Farwickaa| |
Background: Due to its strong water-binding potential, hyaluronic acid (HA) is a well-known active ingredient for cosmetic applications. Native HA is proposed to help the skin to retain and maintain elasticity, turgor and moisture.
Objective: To observe the efficacy of topical application of 0.1% hyaluronan formulations of different molecular weights (MW) (50, 130, 300, 800 and 2000 kDa, respectively) in the periocular area as anti-wrinkle treatment.
Material and Methods: Seventy-six female subjects between 30 and 60 years of age with clinical signs of periocular wrinkles applied one of the formulations twice-daily to the area of interest in a randomized fashion for 60 days. Around the other eye, a vehicle control cream was applied. Measurements of skin hydration and skin elasticity were performed before treatment, 30 and 60 days thereafter. At similar time points negative replicas were taken and evaluated by semi-automated morphometry.
Results: All HA-based creams utilized in this study demonstrated a significant improvement in skin hydration and overall elasticity values (R2) when compared to placebo. Measurements of wrinkle depth using mean roughness (Ra) and maximum roughness (Rz) values revealed significant improvement in the 130 and the 50 kDa HA group after 60 days of treatment compared to placebo-treated area.
Conclusion: Topical application of all 0.1% HA formulations used in this study led to significant improvement in skin hydration and elasticity. Application of low-molecular-weight (LMW) HA was associated with significant reduction of wrinkle depth, which may be due to better penetration abilities of LMW HA.
J Drugs Dermatol. 2011;10(9):990-1000.
Crisaborole Topical Ointment, 2%: A Nonsteroidal, Topical, Anti-Inflammatory Phosphodiesterase 4 Inhibitor in Clinical Development for the Treatment of Atopic Dermatitis
Kurt Jarnagin PhD,a Sanjay Chanda PhD,b Dina Coronado BS,a Vic Ciaravino PhD,a Lee T. Zane MD,a Emma Guttman-Yassky MD PhD,b and Mark G. Lebwohl MDb| |
J Drugs Dermatol. 2016;15(4):390-396.
Complementary Antioxidant Function of Caffeine and Green Tea Polyphenols in Normal Human Skin Fibroblasts
Jared Jagdeo MD MS and Neil Brody MD PhD| |
The study of free radicals is particularly relevant in the context of human skin carcinogenesis and photoaging because of these oxidants´ ability to induce DNA mutations and produce lipid peroxidation byproducts, including 4-hydroxy-2-nonenal (HNE). Therefore, it is important to identify and evaluate agents with the ability to modulate intracellular free radicals and HNE. The purpose of this research is to investigate the ability of antioxidants green tea polyphenols (GTPs) and caffeine, alone and in combination, to modulate the hydrogen peroxide (H2O2)-induced upregulation of reactive oxygen species (ROS) free radicals and HNE in normal human skin fibroblast WS-1 cells in vitro. GTPs and caffeine were selected for evaluation because these compounds have demonstrated antioxidative properties in various skin models. Furthermore, GTPs and caffeine share a close natural botanical association as caffeine is present in green tea, as well. Hydrogen peroxide is a well-known generator of free radicals that is produced during endogenous and UV-induced oxidation processes in human skin and was used to upregulate ROS and HNE in normal human fibroblast WS-1 cells. Using a flow cytometry-based assay, the results demonstrate that at 0.001% concentration, green tea polyphenols alone, and in combination with 0.1 mM caffeine, inhibited the upregulation of H2O2-generated free radicals and HNE in human skin fibroblasts in vitro. Caffeine alone demonstrated limited anti-oxidant properties.
J Drugs Dermatol. 2011;10(7):753-761.
J Drugs Dermatol 2012;11(12):1462-1467.
Development and Clinical Assessment of a Comprehensive Product for Pigmentation Control in Multiple Ethnic Populations
Elizabeth T. Makino BS CCRA MBA,a Kuniko Kadoya PhD,a Monya L. Sigler PhD,b Peter D. Hino MD FAAD,b and Rahul C. Mehta PhDa| |
The Efficacy and Safety of Tavaborole, a Novel, Boron-Based Pharmaceutical Agent: Phase 2 Studies Conducted for the Topical Treatment of Toenail Onychomycosis
Mirna E. Toledo-Bahena MD,a Alicia Bucko DO JD,b Jorge Ocampo-Candiani MD,c Maira E. Herz-Ruelas MD,c
Terry M. Jones MD,d Michael T. Jarratt MD,e Richard A. Pollak DPM MS,f Lee T. Zane MDg
METHODS: One double-blind, randomized, vehicle-controlled study (study 1) and two open-label studies (studies 2 and 3) examined the efficacy, safety, and optimal dosing concentration of tavaborole topical solution applied once daily or three times weekly for 180 days at concentrations of 1.0%, 2.5%, 5.0%, or 7.5%. Patient cohort 3 of study 2 received open-label tavaborole 5.0% once daily for 360 days. All three studies assessed day 180 treatment success, defined as complete or partial clinical evidence of clear nail growth plus negative fungal culture.
RESULTS: A total of 336 patients were included in the intent-to-treat (ITT) or modified ITT populations and efficacy analyses across the 3 studies. In study 1, treatment success rates at day 180 were higher with tavaborole 2.5%, 5.0%, and 7.5% vs vehicle (27%, 26%, and 32% vs 14%, respectively; slope P=0.030). In cohort 3 of study 2, 7% of patients achieved treatment success with tavaborole 5.0% at day 360. Negative culture rates at day 180 in study 1 were numerically higher for tavaborole 2.5%, 5.0%, and 7.5% vs vehicle (slope P=0.046). Application-site reactions of general irritation, erythema, scaling, and stinging/burning were most common with tavaborole 7.5%, were generally mild to moderate, and resolved with treatment discontinuation and/or a reduction in dosing frequency. No systemic safety concerns were observed.
CONCLUSION: Tavaborole solution demonstrated favorable efficacy and safety in phase 2 clinical studies. Based on these findings, tavaborole topical solution, 5% was further investigated in larger, more definitive phase 3 studies. Results from these completed phase 3 studies will provide additional evidence regarding the safety and efficacy of tavaborole in the treatment of toenail onychomycosis.
J Drugs Dermatol. 2014;13(9):1124-1132.
J Drugs Dermatol. 2012;11(6):708-713.
News, Views, & Reviews
The Role of RNA Interference in Dermatology: Current Perspectives and Future Directions
The Sequence of Inflammation, Relevant Biomarkers, and the Pathogenesis of Acne Vulgaris: What Does Recent Research Show and What Does it Mean to the Clinician?
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2013;12(suppl 8):s109-s115.
Alan D. Widgerow MBBCh MMed FCS FACS,a Sabrina G. Fabi MD FAAD FAACS,b
Roberta F. Palestine MD,c Alexander Rivkin MD,d Arisa Ortiz MD FAAD,b Vivian W. Bucay MD FAAD,e
Annie Chiu, MD,f Lina Naga MD,g Jason Emer MD,h and Paul E. Chasan MD FACSi
J Drugs Dermatol. 2016;15(Suppl 4):s63-s71.
David H. McDaniel MD FAAD,a Iltefat H. Hamzavi MD,b Joshua A. Zeichner MD,cSabrina G. Fabi MD FAAD FAACS,d Vivian W. Bucay MD,e Julie C. Harper MD,f Jody A. Comstock MD,g Elizabeth T. Makino BS CCRA MBA,h Rahul C. Mehta PhD,h and Virginia L. Vega PhDh| |
J Drugs Dermatol. 2015;14(suppl 7):s3-s11.
News, Views, and Reviews: Safety & Efficacy of Agents Used for Home Mole Removal and Skin Cancer Treatment in the Internet Age, and Analysis of Cases
Brandon L. Adler and Adam J. Friedman MD| |
Ross Brothers MD, Rawn E. Bosley MD, and Steven Daveluy MD| |
J Drugs Dermatol. 2014;13(8):960-966.
Aikaterini I. Liakou MD,a Michael J. Theodorakis MD,b Bodo C. Melnik MD PhD,c
Apostolos Pappas PhD,d and Christos C. Zouboulis MD PhDa
METHODS: Nutritional clinical studies in dermatology have been reviewed using the MedLine literature source and the terms "diet" or "nutrition" and "skin".
RESULTS & CONCLUSIONS: The data on the relationship between nutrition and skin are until now controversial and much more work is needed to be done to clarify possible etiological correlations.
J Drugs Dermatol. 2013;12(10):1104-1109.
Gary Goldenberg MDa and Omid Hamid MDb| |
Human Stem Cell-Derived Skin Progenitors Produce Alpha 2-HS Glycoprotein (Fetuin): A Revolutionary Cosmetic Ingredient
Gabriel Nistor MD,a Aleksandra J. Poole PhD,a Zoe Draelos MD,b Mary Lupo MD,c Thomas Tzikas MD,d Jerome H. Liu MD,e and Hans S. Keirstead PhDa| |
Human stem cells cultivated in balanced conditions were differentiated into skin lineage precursors, and shown to secrete large amounts of fetuin as well as multiple growth factors beneficial for human skin development and maintenance. The cell secretions were incorporated in two simple cosmetic formulations (serum and lotion) and investigated in an IRB-approved 12-week human trial that included 25 subjects in each group. Subjects were examined at 2, 4, 8, and 12 weeks by a dermatologist to evaluate safety, trans-epidermal water loss, wrinkles, firmness, radiance, texture, softness, and overall appearance. A sub-group of subjects from each group consented for biopsies for histological analyses.
Protein analyses in the cell secretions revealed a high concentration of the multifunctional alpha 2-HS glycoprotein (fetuin) along with a multitude of protein factors involved in the development and maintenance of healthy human skin. Clinical investigation demonstrated significant amelioration of the clinical signs of intrinsic and extrinsic skin aging, findings that were confirmed by significant changes in skin morphology, filaggrin, aquaporin 3, and collagen I content.
Our data strongly support our hypothesis that cosmetic application of stem cell-derived skin lineage precursor secretions containing fetuin and growth factors beneficial for human skin development and maintenance, positively influence intrinsic and extrinsic aging.
J Drugs Dermatol. 2016;15(5):583-598.
Ted Rosen MD| |
J Drugs Dermatol. 2016;15(Suppl 2):s49-55.
Why Is Rosacea Considered to Be an Inflammatory Disorder?
The Primary Role, Clinical Relevance, and Therapeutic Correlations of Abnormal Innate Immune Response in Rosacea-Prone Skin
The pathophysiology of rosacea has undergone renewed interest over the past decade, with a large body of evidence supporting the role of an abnormal innate immune response in rosacea. Many mechanisms interact with the cutaneous innate immune system that may be operative. A variety of potential triggers stimulate this immune detection system which is upregulated and hyper-responsive in facial skin of patients with rosacea as compared to normal skin. Based on the most current data, two conclusions have been reached. First, the major presentations of rosacea appear to be inflammatory dermatoses. Second, the presence of a microbial organism is not a primary or mandatory component of the pathogenesis of rosacea. Available therapies for rosacea exhibit reported modes of action that appear to correlate with the inhibition of inflammatory processes involved in the pathophysiology of at least some presentations of rosacea.
J Drugs Dermatol.2012;11(6):694-700.
Inflammatory Mediators are Inhibited by a Taurine Metabolite in CpG Oligodeoxynucleotide and IFN-r Activated Macrophage Cell Line
Bo Sook Kim DVM PhD,a Daryl S. Spinner PhD,b Richard J. Kascsak PhD,b Seung Yong Park DVM PhD,c In Soo Cho DVM PhD,d Georgia Schuller-Levis PhD,e and Eunkyue Park PhDe| |
J Drugs Dermatol. 2013;12(5):551-557.
Gary Goldenberg MDa and Omid Hamid MDb| |
J Drugs Dermatol. 2013;12(12):1371-1378.
From DNA Repair to Proteome Protection: New Molecular Insights for Preventing Non-Melanoma Skin Cancers and Skin Aging
Enzo Emanuele MD PhD,a James M. Spencer MD MS,b and Martin Braun MDc| |
J Drugs Dermatol. 2014;13(3):274-281.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2013;12(12):1418-1427.
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