Search Results for "Novel Devices and Technologies"
Scott W. Dunbar MDa and David J. Goldberg MDa,b| |
J Drugs Dermatol. 2015;14(11):1229-1238.
John Patrick Welsh MD, Carrie Ann Cusack MD, Christine Ko MD| |
Observations: One to 3 treatments with this combination fractional laser device were performed on 16 Caucasian females with static periocular rhytides or skin laxity affecting the nasolabial crease. There was a 3-week period between treatments. Improvement was noted in both areas after a small number of treatments.
Conclusion: The technology behind fractional lasers is rapidly evolving, and new devices offer significant advances over older prototypes. where id= 776;
Early Improvement in Rhytides and Skin Laxity Following Treatment With a Combination Fractional Laser Emitting 2 Wavelengths Sequentially
K. Wade Foster MD PhD, David J. Kouba MD PhD, Edgar F. Fincher MD PhD, Zachary S. Glicksman, Jennifer Hayes, Valerie Freeman PA, Helen H. Fincher MD, Ronald L. Moy MD| |
Observations: One to 3 treatments with this combination fractional laser device were performed on 16 Caucasian females with static periocular rhytides or skin laxity affecting the nasolabial crease. There was a 3-week period between treatments. Improvement was noted in both areas after a small number of treatments.
Conclusion: The technology behind fractional lasers is rapidly evolving, and new devices offer significant advances over older prototypes.
Macrene Alexiades-Aremenakas MD PhD| |
Suneel Chilukuri MD FAAD FASDS and Gregory Mueller MD FACS| |
Sarah A. Malerich BS,a,b Amer H. Nassar MD,b Andrew S. Dorizas MD,b,d Neil S. Sadick MDb,c| |
J Drugs Dermatol. 2014;13(11):1331-1335.
Macrene Alexiades-Armenakas MD PhD| |
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.
D. Vleggaar MD, R. Forte MD| |
Rhytides, Laxity, and Photoaging Treated with a Combination of Radiofrequency, Diode Laser, and Pulsed Light and Assessed with a Comprehensive Grading Scale
Macrene Alexiades-Armenakas MD PhD| |
Jill Waibel MD, Kenneth Beer MD, Vic Narurkar MDand Tina Alster MD| |
As one of the most powerful and versatile features of the human face, the eyebrow informs the perception of beauty and plays a critical role in sexual dimorphism, facial recognition, and non-verbal communication. Eyebrow hair also serves many important biologic functions, including sensory transmission and protection from the elements, as well as playing an important role in cosmesis and expression.
New technologies to tighten and resurface the skin, to grow the hair of the eyelashes and eyebrows, to smooth-en and lighten the skin, and to replace volume lost from this area have created opportunities for rejuvenation that were not possible until recently. These include prostaglandin analogues that not only increase the length and width of the eyelashes but also improve the length and girth of eyebrow hair. Use of topical bimatoprost daily resulted in an improvement of eyelashes in 78.1% of subjects after 16 weeks. Using it in conjunction with botulinum toxins, light sources, topical cosmeceuticals, and fillers such as hyaluronic acid has vastly improved physicians' ability to treat the periorbital region.
Macrene Alexiades MD PhD| |
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.
David A. Lee MD and Daniel M. Siegel MD MS| |
Amy Miller MD| |
Brian J. Katz MD, Margaret Oliviero FNP BC, Harold Rabinovitz MD| |
Babu Singh MD,a Terrence Keaney MD,b and Anthony M. Rossi MDc,d| |
J Drugs Dermatol. 2015;14(9):1052-1059.
The Use of a Reliable, Ubiquitous, Inexpensive, and User-Friendly Tablet-Based System to Track Target Lesion Improvements in Subjects With Plaque Psoriasis Treated With Clobetasol Propionate 0.05% Spray
Thomas H. Wiser PharmD, Matthew H. Meckfessel PhD, Warren Winkelman MD PhD MBA| |
J Drugs Dermatol. 2015;14(3):236-241.
The Diagnostic Role of Optical Coherence Tomography (OCT) in Measuring the Depth of Burn and Traumatic Scars for More Accurate Laser Dosimetry: Pilot Study
Jill S.Waibel MD,a Ashley C. Rudnick,a Adam J.Wulkan MD,b and Jon D. Holmesc| |
Rosemarie Osborne PhD, Lisa A. Mullins, Bradley B. Jarrold| |
Lewis P. Stolman, MD, FACP, FRCP©| |
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.
Joseph Alcalay, MD| |
METHOD: Maps during MMS were taken using Samsung and LG tablets. The maps were saved to the cloud in the operating rooms. A short time after, the maps were downloaded to the laboratory’s computer by the Mohs technician and processed to a digital photographic map. When additional stage was needed, the map was uploaded by the technician to the cloud and viewed by the Mohs surgeon on the tablet in the operating room.
CONCLUSION: Mohs mapping on the cloud is a new method of mapping tissue in MMS. It is an easy, fast, and accurate method of mapping and serves the new era of modern web and photographic technologies.
J Drugs Dermatol. 2015;14(10):1127-1130.
Flor A. Mayoral MD,a Julie R. Kenner MD PhD,b and Zoe Diana Draelos MDc| |
J Drugs Dermatol. 2014;13(4):414-421.
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
Aditya K. Gupta MD PhD FAAD FRCP(C), Michael Uro DPM, Elizabeth A. Cooper BESc HBSc| |
Successful Use of 1064 Nm Nd:YAG in Conjunction With 2790 Nm YSGG Ablative Laser for Traumatic Scarring
Rajiv I. Nijhawan MDa and Maritza I. Perez MDb| |
J Drugs Dermatol. 2014;13(1):80-81.
Whitney P. Bowe MDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 7):s89-s94.
Flor Mayoral MD| |
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.
Stratum Corneum Permeation and PercutaneousDrug Delivery of Hydrophilic MoleculesEnhanced by Cryopneumatic andPhotopneumatic Technologies
Feng Sun PhD, Robert Anderson PhD, Guillermo Aguilar PhD| |
Laura Schilling MD,a Nazanin Saedi MD,a and Robert Weiss MDb| |
Magdalene Dohil MD, Leslie Baumann MD, Hema Sundaram MD, Jason Emer MD| |
Providing optimal patient outcomes continues to be a challenge in the treatment and management of dermatologic conditions. Most physicians and patients are interested in doing everything possible to optimize the treatment of their skin disease. This is especially important in treating patients with chronic disorders such as eczema, acne, psoriasis, rosacea, photodamage and the negative effects of aging. Physicians and patients often explore the therapeutic benefits of natural ingredients as alternative or complementary treatments to conventional methods. It is important that dermatologists remain up-to-date on the research and new advances in skin care products with natural ingredients.
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 category 1 CME Credit.
Molly Wanner MD MBA, Mathew Avram MD JD| |
Risa Behar Ross DO, and James Spencer MD MS| |
J Drugs Dermatol. 2012;11(11):1296-1299.
J Drugs Dermatol. 2012;11(7):846-851.
Gary D. Monheit MD, Chad L. Prather MD| |
Kimberly J. Butterwick MD, Lorren S. Butterwick, Amy Han MD| |
Jean Carruthers MD, Steven R Cohen MD, John H. Joseph MD, Rhoda S. Narins MD, Mark Rubin MD| |
Christopher B. Zachary FRCPa, Nazanin Saedi MDa, and John Allison PhDb| |
Materials and Methods: A geometric model is described that correlates circumference and fat layer changes following noninvasive body contouring procedures. To validate the geometric model, abdominal measurements were taken with and without an artificial fat pad in place with: 1) a tape measure, 2) ultrasound, and 3) micrometer. The model was then used to analyze the published results of fat layer reduction and circumference changes following noninvasive body contouring procedures.
Results: While there was a high correlation (R2=0.8943) between our ultrasound method and the model with 6 subjects, the correlation between the tape measure method and the model was low (R2=0.0142).
Conclusion: Our results underscore the need for a highly accurate and standardized method for fat measurement. The efficacy in previous studies that had been assessed by tape measure in combination with ultrasound or computed tomography imaging does not conform to the model prediction, which leads us to conclude that the measurements used in those studies were not reliable. Studies reporting efficacy should use such a geometric model to ensure consistency between various measurement methods and to minimize errors due to weight change and measurement technique.
J Drugs Dermatol. 2013;12(1):27-34.
Intense Pulsed Light Pulse Configuration Manipulation Can Resolve the Classic Conflict Between Safety and Efficacy
Inna Belenky PhD, Cruzy Tagger MD, and Andrea Bingham RE| |
J Drugs Dermatol. 2015;14(11):1255-1260.
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.
A Randomized, Prospective Trial Evaluating Surgeon Preference in Selection of Absorbable Suture Material
J Drugs Dermatol. 2012;11(2):196-201.
Ramsin Joseph Yadgar BS,a and Adam J. Friedman MDa,b| |
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.
W.Walsh Thomas MDa and Jason D. Bloom MDb| |
Frank Dreher PhD| |
J Drugs Dermatol. 2016;15(4):457-464.
Prospective Internally Controlled Blind Reviewed Clinical Evaluation of Cryolipolysis Combined With Multipolar Radiofrequency andVaripulseTechnology for Enhanced Subject Results in Circumferential Fat Reduction and Skin Laxity of the Flanks
Julius Few MD,a Michael Gold MD FAAD,b and Neil Sadick MD FACP FAACS FACPh FAADc| |
James M. Spencer MD| |
Laurel M. Morton MD,a Kevin C. Smith MD FRCPC,b Jeffrey S. Dover MD FRCPC,a,c,d,e Kenneth A. Arndt MDa,d,e,f| |
J Drugs Dermatol. 2013;12(11):1219-1222.
Ricardo Ruiz-Rodriguez MD PhD, Laura López-Rodriguez MD| |
Mitalee P. Christman MD,a Daniel Belkin MD,b Roy G. Geronemus MD, a,band Jeremy A. Brauer MDa,b| |
Adrienne N. Choksi MD, Tasneem Poonawalla MD, Michael G. Wilkerson MD| |
Scoping Scalp Disorders: Practical Use of a Novel Dermatoscope to Diagnose Hair and Scalp Conditions
Nicole E. Rogers MD| |
OBJECTIVE: This paper will show how the Canfield DermScope can quickly and easily identify various nonscarring and scarring scalp disorders. Its open design does not change the direction of affected hairs or blanch certain features such as erythema. Features like perifollicular hyperkeratosis and loss of follicular orifices are still easily visible.
METHODS and MATERIALS: The author prospectively photographed patients with hair and scalp disorders in private practice between 2011 to 2012 using the handheld Canfield DermScope device.
RESULTS: The presence of scale, erythema, tufting, miniaturized or broken hairs, and loss of follicular orifices were quickly identified to make a diagnosis.
CONCLUSION: The diagnosis of hair and scalp disorders can be greatly facilitated by the use of the DermScope device.
J Drugs Dermatol. 2013;12(3):283-290.
Allison P. Weinkle BS,a Bryan Sofen MD,b and Jason Emer MDc| |
J Drugs Dermatol. 2015;14(11):1215-1228.
Enhanced Efficacy of Photodynamic Therapy after Fractional Resurfacing: Fractional Photodynamic Rejuvenation
Ricardo Ruiz-Rodriguez MD PhD, Laura López MD, Daniel Candelas MD, Brian Zelickson MD| |
Ross M. Campbell MD, Christopher B. Harmon MD| |
Prospective Efficacy and Safety Evaluation of Laser Treatments With Real-Time Temperature Feedback for Fungal Onychomycosis
Jill Waibel MD, Adam Jared Wulkan MD, and Ashley Rudnick| |
METHODS: Twenty-one patients with PAS or culture proven fungal onychomycosis were prospectively treated with laser until target temperature of 46 - 48 degrees Celsius was achieved using real-time infrared temperature feedback. The laser and light therapies used were 1319nm, 1064nm and BroadBand Light. Exclusion criteria included mixed infection and no other prior therapeutic interventions. Subjects received four treatment sessions one week apart. Assessments included PAS & cultures at one, three and six months post treatment. Patients also were asked a pain score from 1-10 during treatment.
RESULTS: Patients tolerated the procedures well with high satisfaction. Average treatment time was 10 minutes. No adverse events were noted. Patients reported mild-moderate transient discomfort during treatment. Six-month culture results revealed 20/21 negative for fungal organisms.
CONCLUSION: Laser therapy offers a safe and effective new option for onychomycosis. This may be the optimal therapy for a large market that needs alternative or adjunct to current therapies. Laser is quick, painless therapy that does not require any oral medications or blood test for monitoring. Additional larger scientific studies are needed to confirm our pilot study results.
J Drugs Dermatol. 2013;12(11):1237-1242.
Treatment of Nodules Associated With Port Wine Stains With CO2 Laser: Case Series and Review of the Literature
Emily P. Tierney MD, C. William Hanke MD MPH| |
Objective: To search the MEDLINE database and review literature on the treatment of PWS and present 2 cases of adults with PWS, complicated by hypertrophic and nodular lesions, treated successfully with CO 2 laser.
Results: Two patients with PWS, with nodular and hypertrophic areas, were treated with CO 2 laser. With the ﬁrst patient, improve- ment of 90% or greater was noted in the 14 discrete nodules present within the PWS in a V2 distribution. At baseline, ectropion of the lower eyelid was noted which resolved completely after CO 2 laser. With the second patient, improvement was noted as 90% or greater in the 40 of 51 discrete nodules present within the PWS extending across the right V1-V2 distribution.
Conclusion: Carbon dioxide ablative laser resurfacing is safe and highly effective in the treatment of the nodular and hypertrophic components of PWS. Future treatment of PWS will likely involve a hybrid approach of utilizing nonablative lasers of varying wave- lengths and pulse durations and treatment with novel laser devices, with the goal of early treatment to prevent progression of PWS to disﬁguring lesions.
E. Victor Ross MD, Michael Swann MD, Seaver Soon MD,Arash Izadpanah MD, David Barnette MD,Scott Davenport BA| |
Background: Traditional full-face resurfacing has been limited to erbium-doped yttrium aluminium garnet (Er:YAG) and carbon dioxide (CO2) lasers. These devices offer wavelength-specific advantages and disadvantages.
Methods: Nine patients were enrolled in a pilot study of a resurfacing system using a 2790-nm erbium:yttrium-scandium-galliumgarnet (Er:YSGG) laser system. Two treatments were carried out 1 month apart over the entire face. Test spots were performed prior to the full-face sessions to determine the optimal fluence for 1-pass laser resurfacing. Biopsies were performed at the time of treatment and at the final follow-up visit one month after the second treatment. Clinical endpoints included changes in pigment dyschromias, wrinkles, and skin tone. All outcomes were graded by blinded observers.
Results: Eight patients completed the 2 treatments. Biopsies showed thermal damage extending as deep as 80 μm below the stratum corneum. Reepithelialization was complete within 4 days. No scarring, post inflammatory hyperpigmentation (PIH), or infections were observed.
Conclusion: A 2790-nm laser can be used for skin rejuvenation with a 4 day recovery window.
Reductions in Thigh and Infraumbilical Circumference Following Treatment With a Novel Device Combining Ultrasound, Suction, and Massage
K. Wade Foster MD PhD, David J. Kouba MD PhD, Jennifer Hayes, Valerie Freeman PA, Ronald L. Moy MD| |
Philip D. Shenefelt MD MS| |
Intense Pulsed Light versus Advanced Fluorescent Technology Pulsed Light for Photodamaged Skin: A Split-Face Pilot Comparison
Martin Braun MD| |
David Lortscher MD,a Shehla Admani MD,b Nancy Satur MD,a and Lawrence F. Eichenfield MDb,c| |
METHODS: At the time of initial consultation for acne, each of 2147 consecutive patients using hormonal contraception provided her assessment of how her contraceptive had affected her acne. The Kruskal-Wallis test and logistic regression analysis were used to compare patient-reported outcomes by contraceptive type.
RESULTS: Depot injections, subdermal implants, and hormonal intrauterine devices worsened acne on average, and were inferior to the vaginal ring and combined oral contraceptives (COCs; P ≤ .001 for all pairwise comparisons), which improved acne on average. Within COC categories, a hierarchy emerged based on the progestin component, where drospirenone (most helpful) > norgestimate and desogestrel > levonorgestrel and norethindrone (P ≤ .035 for all pairwise comparisons). The presence of triphasic progestin dosage in COCs had a positive effect (P = .005), while variation in estrogen dose did not have a significant effect (P = .880).
CONCLUSIONS: Different hormonal contraceptives have significantly varied effects on acne, including among types of COC.
J Drugs Dermatol. 2016;15(6):670-674.
Enhanced Full-Face Skin Rejuvenation Using Synchronous Intense Pulsed Optical and Conducted Bipolar Radiofrequency Energy (ELOS): Introducing Selective Radiophotothermolysis
Neil S. Sadick MD FACP FAACS, Macrene Alexiades-Armenakas MD PhD, Patrick Bitter Jr. MD, George Hruza MD, R. Stephen Mulholland MD| |
Objective: The authors report their experience using an ELOS system (Aurora SR, Syneron, Yokneam, Israel) on 108 consecutive patients treated with a series of full-face procedures.
Methods: Patients received 5 full-face treatments every 3 weeks. Each treatment consisted of 1 to 8 full-face and segmental passes. The number of passes, specific wavelength of pulsed optical energy, and RF energy were determined by the patient’s skin type, dyschromia, wrinkle pathology, and presence of a tan. A total of 540 treatments were performed on 108 subjects. All patients had pre- and post-procedural photographs. Results were assessed by double-blinded physician photographic evaluation and patient satisfaction scales.
Results: Overall skin improvement was rated at 75.3%. Overall average wrinkle improvement was 41.2%, with an average Class 1 wrinkle improvement of 64.7%, Class 2 wrinkle improvement of 38.6%, and Class 3 wrinkle improvement of 20.4%. Improvement in skin laxity was rated at 62.9%. Skin texture was reported to improve 74.1%. Improvement in the appearance of pore size was rated at 65.1%. Average improvement in erythema and telangiectasia was 68.4%. Average improvement in hyperpigmentation and dyschromia was 79.3%. Overall patient satisfaction was 92%. The overall minor complication rate, including blistering, crusting, and stripping was 8.3%, and the major complication rate was less than 1%. One small, depressed nasal scar was observed in one patient.
Conclusions: This study demonstrates the safety and efficacy of a new technology using combined optical and conducted bipolar RF energies for noninvasive skin rejuvenation. The results show improvement in wrinkle reduction and amelioration of erythema, telangiectasia, and hyperpigmentation comparable to that reported for other intense pulsed light technologies.
Braden McKnight BS,a Rachel Tobin BS,b Yasmeen Kabir MD,c and Ronald Moy MDa| |
METHODS & MATERIALS: Twelve females received eight weekly non-ablative treatments using a tripolar radiofrequency device on the anterior and posterior upper arms. Evaluations included body weight, photographs, and circumference measurements at baseline and each subsequent week throughout the 8-week time period. The subjects and the investigator completed evaluations of clinical improvement using a 5-point assessment scale.
RESULTS: A significant circumference reduction was achieved in each arm of all twelve patients. A mean reduction of 1.99 ± 0.94 cm (P=0.001) was observed between the initial and final measurements after the 8-week treatment period. At the 4-week follow up, the average circumferential reductions of the posterior and anterior upper arms were sustained. Patient evaluations indicated moderate to good improvement of size, tightness, and overall appearance. The procedure was well tolerated without pain.
CONCLUSION: Tripolar radiofrequency devices offer a safe and effective non-invasive technology with beneficial effects on the circumferential reduction and overall appearance of the posterior and anterior upper arms.
J Drugs Dermatol. 2015;14(12):1463-1466.
Surgical Corner. Evaluation of the Wound Healing Response After Deep Dermal Heating by Fractional Micro-needle Radiofrequency Device: Animal Study
So Dug Lim MD PhD,a Un-Cheol Yeo MD PhD,b,c Il-Hwan Kim MD PhD,d
Chong Won Choi MD,cand Won-Serk Kim MD PhDc
METHODS: Porcine back skin was used in the study. A FRM device was composed of 49 insulated needles. Needles were vertically inserted with 1.5mm depth and four different energy levels were used to examine wound healing response chronologically. Histologic evaluation was done by hematoxylin & eosin (H&E) and heat shock proteins (HSP) 47 staining for immediately after, 2 days after, 14 days after, 28 days after and 10 weeks after the procedure. RT-PCR was done for various cytokines including HSP47, HSP72, metalloproteinase (MMP), and extracellular matrix (ECM) proteins.
RESULTS: FRM treatment generated a thermally coagulated zone localized in the reticular dermis, without damaging the epidermis. The coagulation necrosis zone in H&E staining was replaced by new collagen tissue over 10 weeks. RT-PCR studies revealed an increase in HSP, MMPs, and ECM proteins. In the high energy level procedure, an increased number of fibroblasts were found.
CONCLUSION: FRM treatment induced a dermal remodeling process including neocollagenesis in the deep dermis. From this result, FRM is expected to provide a good and positive efficacy for skin rejuvenation.
J Drugs Dermatol. 2013;12(9):1044-1049.
Amy Forman Taub MD| |
Skin Rejuvenation in Asian Skin: The Analysis of Clinical Effects and Basic Mechanisms of IntensePulsed Light
Yujie Feng, Junying Zhao, Michael H. Gold MD| |
Objectives: The objective of this clinical trial was to evaluate the effects and the mechanism of action of an IPL by comparing clinical photographs and biopsy results before and after treatment.
Methods: A total of 58 patients were treated using a new IPL device. Clinical photographs were taken before treatment and compared to those taken 3 weeks after the treatment. Also, 4 cases had pathological analyses of tissues that were stained by haematoxylin-eosin and Uana orcein. Immunohistology of human collagen of types 1 and 3 and quantitative analyses of elastin and collagen were performed by a poly-functional digital image light microscope; a transmission electron microscope was used for 2 of the cases to look for additional changes.
Results: After 3 treatments, 62.1% of the patients showed improvement in wrinkles and skin texture. Pigmentation improved in 84.6% of the patients, and a reduction in telangiectasis was seen in 81.25% of the patients. Pathological examination showed that both type 1 and type 3 collagens increased following treatment, but elastin content decreased; however, the elastin fibers were arranged more neatly. In the transmission electron microscope study, the amount of fibroblast activity increased, the fibroblasts were more active, and there were more collagen fibers neatly rearranged within the stroma.
Conclusion: Clinical and pathological studies demonstrated that the IPL was effective in improving wrinkles and skin texture. The mechanism of action may be through the increasing activity of the fibroblasts, hyperplasia of the fibroblasts, and rearrangement of both collagen and elastin within the stroma.
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| |
Ava T. Shamban MD, Mikiko Enokibori MD, Vic Narurkar MD, Donna Wilson RN| |
Methods: In a retrospective multicenter study, clinical data were collected from 56 patients with mild to severe acne. Patients had been treated 2 to 4 times with a portable photopneumatic device (Aesthera PPx, Aesthera Corporation, Pleasanton, CA) that delivers broadband light (400 to 1200 nm) to the treatment site via a hand piece. For 11 of the 56 photographs taken before and after PPx treatment.
Results: For the 56 patients, the median physician-rated clearance increased from 50% after a single treatment to 90% after the fourth treatment, whereas the median patient-rated clearance improved form 50% after a single treatment to 78% after the fourth treatment. On a 4-point scale, both physician-rated and patient-rated median overall satisfaction levels increased from a 3 after a single treatment, to 4 after the second, third, and fourth treatments. Clinically significant adverse events were not observed. For the 11 patients evaluated by photography, the median papule and pustule lesion counts decreased from 2 to 0, respectively. Median acne severity (Burton scale) decreased from 2 before treatment to 1 after the final treatment (scale 1-4). Adverse events were limited to mild erythema.
Conclusion: Photopneumatic technology provides a safe and effective treatment of mild to sever acne vulgaris.
Two-Treatment Protocol for Skin Laxity Using 90-Watt Dynamic Monopolar Radiofrequency Device With Real-Time Impedance Intelligence Monitoring
David McDaniel MD,a Robert Weiss MD,b Margaret Weiss MD,b Chris Mazur BS,a and Charmaine Griffin CCRPa| |
OBJECTIVE: The objective was to validate effectiveness of a modified treatment protocol for a unique monopolar radiofrequency device, which has been engineered with greater power and self-monitoring circuitry.
METHODS: Twenty-four female subjects received bilateral monopolar radiofrequency treatments to the mid and lower face from the sub malar region to the submentum. Subjects completed 1 and 3 month follow ups with digital imaging. Skin biopsies (on 4 subjects) and ultrasound measurements (on 12 subjects) were completed.
RESULTS: Assessments demonstrated a reduction in skin laxity of 35%, a reduction in fine lines/wrinkles of 42%, and a reduction in the appearance of global photodamage of 33%. Expert photograding demonstrated 92% of subjects showing at least a mild improvement in skin laxity at three months post treatment. 50MHz ultrasound measurements in 12 subjects showed an increase of 19% in skin density. Histology showed a marked increase in dermal collagen and elastin fibers in two subjects who demonstrated a clinically noticeable reduction in skin laxity and minimal changes in two subjects who demonstrated minimal clinical improvements. There were no significant adverse events reported.
CONCLUSION: This modified radiofrequency device and treatment protocol was well tolerated and produced improvements in the appearance of skin laxity and overall anti-aging effects in the majority of subjects. Objective measurements including ultrasound and histology help explain the clinical outcome.
J Drugs Dermatol. 2014;13(9):1112-1117.
An Over-the-Counter Moisturizer Is as Clinically Effective as, and More Cost-Effective Than, Prescription Barrier Creams in the Treatment of Children With Mild-to-Moderate Atopic Dermatitis: A Randomized, Controlled Trial
Background: Atopic dermatitis (AD) is a prevalent skin disorder with significant cost of treatment. Several prescription device moisturizers have been approved by the FDA to treat AD but are significantly more expensive than well-crafted over-the-counter (OTC) moisturizers. No studies have been performed to compare both the clinical efficacy and cost-efficacy of these prescription devices to OTC moisturizers.
Purpose: The purpose of this study is to compare the clinical efficacy and cost-efficacy of a glycyrrhetinic acid-containing barrier repair cream (BRC-Gly, Atopiclair®), a ceramide-dominant barrier repair cream (BRC-Cer, EpiCeram®) and an OTC petroleum-based skin protectant moisturizer (OTC-Pet, Aquaphor Healing Ointment®) as monotherapy for mild-to-moderate AD in children.
Methods: Thirty-nine patients, age 2-17 years, with mild-to-moderate AD were randomized 1:1:1 to receive one of three treatments—BRC-Gly, BRC-Cer or OTC-Pet—with instructions to apply the treatment three times daily for three weeks. Disease severity and improvement was assessed at baseline and on days 7 and 21.
Results: No statistically significant difference for any efficacy assessment was found between the three groups at each time point. The OTC-Pet was found to be at least 47 times more cost-effective than BRC-Gly or BRC-Cer.
Limitations: The relatively small sample size of 39 subjects was not sufficient to establish OTC-Pet as superior treatment in AD.
Conclusions: OTC-Pet is as effective in treating mild-to-moderate AD as both BRC-Gly and BRC-Cer and is at least 47 times more cost-effective.
Name of registry: II-AF-ATD-Aquaphor, Comparing the Efficacy and Cost-Effectiveness of Aquaphor to Atopiclair and EpiCeram in Children with Mild to Moderate Atopic Dermatitis
Registration Identifier: NCT01093469
J Drugs Dermatol. 2011;10(5):531-537.
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.
Understanding the Complexities of the Stratum Corneum: Considerations and Strategies for Skin Barrier Maintenance Continuing Education Article Series
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.
Bipolar Radiofrequency in the Treatment of Dermatologic Imperfections: Clinicopathological and Immunohistochemical Aspects
Gianni Montesi MD, Stefano Calvieri MD, Alberto Balzani MD, Michael H. Gold MD| |
Monopolar Radiofrequency Facial Tightening: A Retrospective Analysis of Efficacy and Safety in Over 600 Treatments
Robert A. Weiss MD, Margaret A. Weiss MD, Girish Munavalli MD MHS, Karen L. Beasley MD| |
Study Design: Charts and clinical images of over 600 consecutive patient treatments between May 2002 and June 2006 using a monopolar radiofrequency device (Thermacool®, Thermage, Haywood, CA) for skin tightening at the Maryland Laser, Skin and Vein Institute were retrospectively reviewed. The primary presentation for treatment was skin laxity of the lower face. Treatment was delivered with a 1-cm2 standard tip at fluences of 81 to 124 J/cm2 (level of 12.5 to 15), a 1-cm2 “fast” tip at fluences of 62 to 109 J/cm2 (level of 72.0 to 76.0), a 1.5-cm2 “big fast” tip at fluences of 75 to 130 J/cm2 (level of 61.5 to 65), and a 3-cm2 “bigger” tip at equivalent fluences as each became available. As treatment algorithms evolved over 4 years, the algorithm of multiple passes at lower fluence associated with better clinical outcomes and greater patient acceptance has been adopted.
Conclusions: Our data, obtained in an office setting without injectable anesthetic or IV sedation, indicate that monopolar RF for skin tightening is ver safe procedure. The treatment algorithm and tips have evolved over several years leading to increased safety and efficacy. Side effects are infrequent, self-limited, and minor, comparing favorably to other nonablative devices utilized for facial rejuvenation.
Selective Non-contact Field Radiofrequency Extended Treatment Protocol: Evaluation of Safety and Efficacy
Amir Moradi MDa and Melanie Palm MDb| |
METHODS:Twenty-five subjects enrolled in the IRB approved multi-center study to receive four weekly 45-minute RF treatments to the abdomen and love handles. Standardized digital photographs and circumference measurements were taken at baseline and at the 1- and 3-month follow-up visits. Biometric measurements including weight, hydration and body fat were obtained at baseline and each study visit. A subset of 4 subjects were randomly selected to undergo baseline serum lipid and liver-related blood tests with follow-up labs taken: 1 day post-treatment 1, 1 day post-treatment 4, and at the 1- and 3-month follow-up visits.
RESULTS: Twenty-four subjects (22 female, 2 male), average age of 47.9 years (30-69 years), completed the study. The data of the twenty-four subjects revealed a statistically significant change in circumference P<.001 with an average decrease in circumference of 4.22cm at the 3-month follow-up visit. Lab values for the subset of 4 subjects remained relatively unchanged with only minor fluctuations noted in the serum lipid values in two of the subjects. Three independent evaluators viewed pre-treatment and 3-month post treatment photographs to determine which photo was the after photo. The evaluators were able to correctly identify the post treatment photos with an 88% accuracy rate. Treatments were well tolerated by all subjects. No study related adverse events were reported.
CONCLUSION: This study found that an extended treatment protocol using a selective RF device is a safe and effective method for the reduction of circumference and improved contouring of the abdomen and love handles.
J Drugs Dermatol. 2015;14(9):982-985.
Effect of Controlled Volumetric Tissue Heating with Radiofrequency on Cellulite and the Subcutaneous Tissue of the Buttocks and Thighs
Ramón H. Rosado MD, Ma. Emilia del Pino MD, Alejandro Azuela MD, Ma. Graciela Guzmán MD,| |
Macrene R. Alexiades-Armenakas MD PhD| |
Anne Chapas MD FAAD and Kendra Gail Bergstrom MD FAAD| |
Deborah S. Sarnoff MD| |
Neil Sadick MD| |
Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Dermatologists and MelaFind: A Pilot Survey Study
Ryan Wells MD| |
William Levis MD| |
Kendra Gail Bergstrom MD FAAD| |
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.
Lucija Kroepfl MBChBa and Jason J. Emer MDb| |
Home-Based Wrinkle Reduction Using a Novel Handheld Multisource Phase-Controlled Radiofrequency Device
Neil S. Sadick MD,1 Yoram Harth MD,2,3 Andrew S. Dorizas MD,6 Hanna Levy PhD,4 and Avner Shemer MD5| |
PATIENTS AND METHODS: A total of 69 participants (age 54.3 years ± 8.09; age range 37-72 years) were enrolled in the study after meeting all inclusion/exclusion criteria (100%) and providing informed consent. Participants were provided with the tested device together with a user manual and treatment diary, to perform independent treatments at home for 4 weeks. The tested device, (Newa™, EndyMed Medical, Cesarea, Israel) emits 12 W of 1Mhz, RF energy through six electrodes arranged in a linear fashion. Independent control of RF polarity through each one of the 6 electrodes allows significant reduction of energy flow through the epidermis with increased dermal penetration. Participants were instructed to perform at least 5 treatments a week, for one month. Four follow-up visits were scheduled (once a week) during the period of independent treatments at home, following 4 weeks of home treatments, 1 month follow-up visit (1 month after treatment end) and at 3 months follow-up (3 months following treatment end).
Analysis of pre-and post treatment images was conducted by three uninvolved physicians experienced with the Fitzpatrick Wrinkle and Elastosis Scale. Fitzpatrick Wrinkle and Elastosis score of each time point (4 weeks following home use treatments; 1 month follow-up, 3 months follow-up) was compared to baseline.
Participants were asked a series of questions designed to explore usability concerns and level of satisfaction regarding the device use and subjective efficacy.
RESULTS: Altogether, 62 subjects completed the study course and follow-up visits. No unexpected adverse effects were detected or reported throughout the independent treatment. All study participants did not experience any difficulties while operating the tested device for independent wrinkle reduction treatments. Photographic analysis of pre- and post-one month of independent home use treatments, and one and three months follow-up after end of treatment course, was conducted by three uninvolved board certified dermatologists. Analysis of results revealed improvement (downgrade of at least 1 score according to the Fitzpatrick scale) in 91.93%, 96.77%, and 98.39% of study subjects (according to the first, second, and third reviewer, respectively). Results were found to be statistically significant. The majority of study participants were very satisfied from the results of the independent treatment using the tested device for wrinkle reduction.
J Drugs Dermatol. 2014;13(11):1342-1347.
Flor A. Mayoral MD and Janelle M. Vega| |
J Drugs Dermatol. 2011;10(11):1320-1321.
Douglas Winstanley DO, Travis Blalock MD, Nancy Houghton BS, and E. Victor Ross MD| |
Methods: Four patients with sebaceous hyperplasia underwent a test spot treatment followed by 2 full treatment sessions using the 1,720-nm laser. Photos were taken before treatment, at each treatment session, and 3 months following the last treatment. Pretreatment photographs and 3-month follow-up photographs were compared to assess efficacy.
Results: Four weeks after the final treatment, 3 dermatologists blinded to the date of the photographs and uninvolved with the study evaluated the photos and scored them based on a global assessment comprised of: 1) lesion diameter, 2) lesion height, and 3) lesion color. Many of the lesions resolved almost completely after a single treatment, and no additional treatment was required. Overall, there was a reduction in the color, diameter, and height of the lesions. Crusts were noted by all patients and resolved within 10 days.
Conclusion: The use of this novel device that exploits the intrinsic selectivity of 1,720 nm achieved nearly complete clearance of sebaceous hyperplasia lesions without depressions or scarring. Complete heating of the sebaceous gland and sparing of the surrounding skin offered by this device resulted in clinically apparent improvement with a minimum of adverse effects.
J Drugs Dermatol. 2012;11(11):1323-1326.
Selective Radiofrequency Therapy as a Non-Invasive Approach for Contactless Body Contouring and Circumferential Reduction
Kateřina Fajkošová MUDr,a Alena Machovcová MD PhD MBA,b,c Meltem Onder MD,d and Klaus Fritz MDd,e| |
J Drugs Dermatol. 2014;13(3):291-296.
Andrew F. Alexis MD MPH| |
Adam Friedman MD| |
Safety and Efficacy of a New Device Combining Radiofrequency and Low-Frequency Pulsed Electromagnetic Fields for the Treatment of Facial Rhytides
Methods: Thirty-one subjects with facial wrinkles and rhytides were entered into this study. Every subject received 10 treatments of the face with a device that combines 1 MHz radiofrequency with PEMF with a flux of 15 gauss. Patients rated the pain level immediately after the treatment by using a visual analog scale (VAS) for pain. Side effects were recorded at every visit. The study's efficacy end point was evaluated by 2 blinded physicians who rated the standardized pictures from baseline and 3-month follow-up using the Fitzpatrick Wrinkle and Elastosis Scale (FWES).
Results: No unexpected adverse side effects were detected or reported for the duration of the study. Both raters recognized improvements of at least 1 grade on the FWES in 30 of 31 subjects (97%). The score decreased from 5.2 before the first treatment to 3.6 at 3 months after the last treatment. Furthermore, all patients rated the treatment to be free of pain on the VAS pain scale.
Conclusion: The results of this study show that the combination of multipolar RF with PEMF is a safe, effective, and painless approach to treat facial rhytides and is suitable to answer the demands of patients for safe treatments without pain or downtime.
J Drugs Dermatol. 2012;11(11):1306-1309.
Ronald L. Moy MD| |
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.
Kenneth R. Beer MD FAAD,a Stephanie Bayers BSBA,b and Jacob Beerc| |
J Drugs Dermatol. 2014;13(suppl 1):s17-s20.
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.
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa| |
A Preliminary Study on the Safety and Efficacy of a Novel Fractional CO2 Laser With Synchronous Radiofrequency Delivery
Robert H. Gotkin MD FACSa,c and Deborah S. Sarnoff MD FAAD FACPb,c| |
J Drugs Dermatol. 2014;13(3):299-304.
Maritza I.Perez MD| |
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.
Flor A. Mayoral MD| |
Multi-Center Clinical Study and Review of Fractional Ablative CO2 Laser Resurfacing for the Treatment of Rhytides, Photoaging, Scars and Striae
Macrene Alexiades-Armenakas MD PhD FAAD,a Deborah Sarnoff MD, Robert Gotkin MD, Neil Sadick MD| |
Laser skin resurfacing has shifted over the past two decades from standard ablative resurfacing to non-ablative resurfacing and most recently, to fractional laser resurfacing. In this most recent category, fractional non-ablative lasers were first introduced followed by fractional ablative lasers, which offer an improved balance between safety and efficacy. In the current article, a review of fractional ablative resurfacing is presented alongside the results from a multi-center clinical study employing the fractional carbon dioxide (CO2) laser (SmartXide DOT, DEKA) for the treatment of rhytides, photoaging, scars and striae distensae.
J Drugs Dermatol. 2011;10(4):352-362.
Clinical Evaluation of the Safety and Efficacy of a Novel Superficial and Deep Carbon Dioxide Fractional System in the Treatment of Patients With Skin of Color
J Drugs Dermatol. 2012;11(11):1331-1335.
Macrene Alexiades-Armenakas MD PhD| |
Macrene Alexiades-Armenakas MD PhD holds three Harvard degrees, an extensive 20+ year background in research, and runs clinical and laboratory studies focusing on anti-aging skin care, acne, skin cancer, and lasers. Her clinical practice on Park Avenue is focused on dermatology and laser surgery. Dr. Alexiades holds a BA from Harvard University, where she was elected to Phi Beta Kappa and awarded the Fay Prize, the highest undergraduate honor, an MD from Harvard Medical School, and a PhD in Genetics from Harvard University. She is dual certified in medicine, surgery, and dermatology in the EU as well as the US.
Jeremy B. Green MD a board-certified dermatologist, graduated cum laude with a bachelor's degree from Princeton University. He completed his medical education at the Northwestern University Feinberg School of Medicine and the University of Miami Miller School of Medicine where he graduated with Alpha Omega Alpha (AOA) honors. He trained at the University of Miami Department of Dermatology where he served as its chief resident. Dr. Green currently practices with Dr. Brandt Dermatology Associates in Coral Gables, Florida, where they have chosen to make the Excel V laser an integral part of their practice.
Neil Sadick MD FAAD FAACS FACP FACPh a native New York City resident, completed his medical school training at SUNY Upstate. His residency, in internal medicine, was completed at Cornell/North Shore University/Memorial Sloan Kettering Medical Center. Dr. Sadick then went on to train in dermatology at New York Hospital, during which time he served as chief resident until the completion of his training in 1983. Dr. Sadick holds five board certifications in internal medicine, dermatology, cosmetic surgery, hair restoration surgery, and phlebology. Dr. Sadick is the medical director and owner of Sadick Aesthetic Surgery and Dermatology with locations on Park Avenue in New York City and Great Neck, Long Island.
David B. Vasily MD FAAD received a Bachelor of Science in Biology degree, with honors from Moravian College, magna cum laude. He obtained his medical degree from SUNY at Buffalo School of Medicine. Following his internship at Allentown Hospital, he completed a dermatology residency at Geisinger Medical Center in Danville, Pennsylvania. Dr. Vasily is board-certified by the American Board of Dermatology and a Fellow of the American Academy of Dermatology. He is a well-known dermatologist, who has also served as founder and president of Lehigh Valley Dermatology Associates, Ltd. since its inception over 30 years ago.
Resident Rounds: Part I: Program Spotlight: The University of California, Irvine Department of Dermatology Residency Training Program
Nazanin Saedi MD, Amy Reinstadler MD, Sam Truong MD, Kristen Kelly MD| |
Resident Rounds is a new section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds will feature three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the University of California, Irvine Department of Dermatology Residency Training Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. Dr. Ibrahimi is a recent graduate of the Harvard Combined Program in Dermatology and currently a fellow in Mohs, Laser and Cosmetic Surgery at the University of California Davis. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at email@example.com
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.
Expanding the Clinical Application of Fractional Radiofrequency Treatment: Findings on Rhytides, Hyperpigmentation, Rosacea, and Acne Redness
Wichai Hongcharu MDa and Michael Gold MDb| |
J Drugs Dermatol. 2015;14(11):1298-1304.
Quantitative & Qualitative Evaluation of the Efficacy of a 1440 nm Nd:YAG Laser With Novel Bi-Directional Optical Fiber in the Treatment of Cellulite as Measured by 3-Dimensional Surface Imaging
Bruce Katz MD| |
OBJECTIVE: To evaluate the safety and efficacy of a single cellulite treatment using an Nd:YAG 1440-nm laser delivered with a special fiber delivery system and temperature control.
METHODS: Women with cellulite on their thighs and buttocks were enrolled in a prospective Institutional Review Board–approved study. Subjects were 15 healthy females of all Fitzpatrick Skin types with cellulite (grades II-III). A single treatment was performed with an average of seven 5 x 5 cm squares treated per leg. Evaluations with 2D and 3D imaging, patient and blinded evaluator scales as well as skin histology were performed at baseline, 3 and 6 months post treatment.
RESULTS: In the 2D photographs, blinded evaluators were able to identify treated photographs versus baseline in 90% of cases and the number of sites with improvement in contour irregularities was 94%. With 3D imaging, the average decrease in skin depressions (dimples) was 49% at 6 months and 66% of patients showed improvement in overall skin contour at 6 months follow-up. Patient and physician satisfaction scores were high and no adverse events were reported.
CONCLUSION: The Nd:YAG 1440 nm laser with a special fiber delivery system produced significant improvement in cellulite with one treatment after 6 months of follow up. There were no adverse events.
J Drugs Dermatol. 2013;12(11):1224-1230.
Georgia Schuller-Levis MD,a William Levis MD,b and Israel Dvoretzkyc| |
J Drugs Dermatol. 2014;13(10):1194-1196.
Combined Fractional Ablative and Nonablative Laser Resurfacing Treatment:A Split-Face Comparative Study
Joel L. Cohen MDa and E. Victor Ross MDb| |
Objective: The purpose of this study was to compare a combined fractional ablative and nonablative laser procedure to ablative-only procedures for facial rejuvenation. Methods: A total of 8 subjects in 2 study groups received a single, split-face, facial rejuvenation procedure in this study. In group A, we compared a combined procedure using a fractional nonablative 1,440-nm neodymium-doped yttrium aluminum garnet (YAG) laser and a fractional ablative 2,940-nm erbium (Er)-doped YAG laser on one side of the face, and a combined confluent/fractional ablative Er:YAG laser on the other. In group B, we compared the same 1,440/2,940 treatment as group A on one side of the face, and a fractional ablative CO2 laser on the other. Subjects were followed for 3 months to assess side effects and improvement in Fitzpatrick Wrinkle Score and pigmentation.
Results: Improvement in wrinkles and pigment were seen with all techniques in both groups, and results were equivalent. Areas treated with combined fractional nonablative and ablative technique demonstrated fewer immediate side effects.
Conclusion: Facial rejuvenation using a combination treatment of fractional ablative 2,940 and nonablative 1,440 lasers provides improvement in wrinkles and pigment similar to conservative purely ablative approaches. These purely ablative approaches include the Er:YAG laser used in a sequential confluent fractional manner, or fractional CO2 laser alone. Reduced side effects make the combined procedure an attractive option for facial rejuvenation.
J Drugs Dermatol. 2013;12(2):175-178.
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.
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
C. William Hanke MD MPH FACP| |
Dr. Sherry Hsiung| |
Deborah S. Sarnoff MD FAAD FACP| |
Martin Ray MDa and Michael Gold MDb| |
J Drugs Dermatol. 2015;14(11):1268-1271.
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.
Erin Courtney RN BSN and David J. Goldberg MD JD| |
Eric F. Bernstein MD MSE,a Jay Bhawalkar PhD,b Joan Clifford MS,b James White,b James Hsia PhDb| |
Background: Due to the hemoglobin-selective wavelength of the 595 nm pulsed-dye laser, it is a device of choice for treating cutaneous
vascular lesions. However, it is less effective and removing dyschromia, which along with hypervascularity is a cardinal sign of cutaneous
photodamage. A novel 607 nm dye laser was developed as a first step in creating a dual-wavelength pulsed-dye laser.
Study Design/Materials and Methods: Twenty-five subjects with dyschromia on the chest due to chronic photodamage were enrolled into an open-label study to explore the safety and efficacy of a 607 nm pulsed-dye laser, with 22 completing the study. Two treatments were administered to the chest, one month apart, with fluences ranging from 3-6 J/cm,2 using a 10 mm diameter spot and pulse duration of 1.5 msec. Cross-polarized digital photographs were taken before and two months following the final treatment and rated for improvement by physicians in a blinded fashion.
Results: Improvement was rated on a five-point scale with no subjects rated as poor (<25%) clearance, three subjects (13.6%) demonstrating fair (26-50%) improvement, seven subjects (31.8%) rated as good (51-75%) improvement, 12 (54.5%) were rated as excellent (76-95%) improvement, while none were rated as outstanding improvement (>95%).
Conclusion: This is the first study of the 607 nm pulsed-dye laser which showed it to be safe and effective for treating dyschromia of the chest due to chronic photodamage, and may in the future expand the ability of the pulsed-dye laser to treat photodamaged skin.
J Drugs Dermatol. 2011;10(4):388-394.
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.
María Sol Brassesco PhD,a Elvis Terci Valera MD PhD,b Julia Alejandra Pezuk PhD,c Karina Bezerra Salomão MSc,c Carlos Alberto Scrideli MD PhD,b and Luiz Gonzaga Tone MD PhDb| |
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.
Moetaz El-Domyati MD,a Tarek S. El-Ammawi MD,a Osama Moawad MD,b Walid Medhat MD,a, c Mỹ G. Mahoney PhD,c Jouni Uitto MD PhDc| |
Background: The use of intense pulsed light (IPL) for facial rejuvenation had been the topic of many studies. However, few of them
discussed quantitative changes in extracellular matrix proteins after IPL therapy.
Objective: To objectively quantify the histological changes in extracellular matrix proteins after IPL treatment for facial wrinkles.
Methods: Biopsy specimens were obtained from the periocular area of six volunteers of Fitzpatrick skin type III–IV and Glogau's class I–III wrinkles. They were subjected to three months of IPL treatment (six sessions at two-week intervals). Using histological and immunostaining analysis coupled with computerized morphometric analysis, quantitative evaluation of collagen types I, III and VII, newly synthesized collagen, total elastin and tropoelastin was performed for skin biopsies at baseline, end of treatment, and three months post-treatment.
Results: Clinical assessment of volunteers did not show clinically noticeable improvement in facial wrinkles after IPL treatment. Furthermore, quantitative evaluation of extracellular matrix proteins showed no statistically significant changes (P>0.05) in response to IPL treatment.
Conclusion: Although 50 percent of volunteers showed mild improvement in skin texture at the end of IPL treatment, none of them reported improvement in skin tightening or wrinkles. No statistically significant histological changes were observed three months post IPL treatment.
J Drugs Dermatol. 2011;10(11):1246-1252.
Kendra Gail Bergstrom MD FAAD| |
J Drugs Dermatol. 2011;10(2):125-132
J Drugs Dermatol. 2012;11(9):e5-e9.
Emily Stamell Ruiz MD,a Amber Ingram BS,b Angelo Landriscina BA,b Jiaying Tian MD MPH,b Robert S. Kirsner MD PhD,c and Adam Friedman MDb,d| |
OBJECTIVES: To identify United States (US) dermatology residents’ impressions regarding their preparedness to care for wounds, and to assess the amount and type of training devoted to wound care during residency.
DESIGN, SETTING, AND PARTICIPANTS: An online survey among current US dermatology residents enrolled in a residency training program.
MAIN OUTCOMES AND MEASURES: The primary goal was to determine whether dermatology residents believe more wound care education is needed, evaluate preparedness to care for wounds, and identify future plans to manage wounds.
RESULTS: Responses were received from 175 of 517 (33.8%) US Dermatology residents contacted. The majority of residents did not feel prepared to manage acute (78.3%) and chronic (84.6%) wounds. Over three quarters (77.1%) felt that more education is needed. Fewer than half (49.1% and 35.4%) of residents planned to care for acute and chronic wounds, respectively, when in practice.
CONCLUSIONS AND RELEVANCE: There is a gap in wound care education in US dermatology residency training. This translates to a low percentage of dermatology residents planning to care for wounds in future practice. Dermatology residents need to receive focused wound care training in order to translate the underpinnings of wound healing biology and ultimately better serve patients.
J Drugs Dermatol. 2015;14(7):716-720.
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.
Mary P. Lupo MD FAAD| |
Douglas J. Key MD| |
METHODS: Subjects (n=14) presenting with abdominal laxity were treated up to four times using the transcutaneous monopolar RF device at one or two zones in the abdominal region (at operator’s discretion). Non-expert blinded graders rated correction on an arbitrary scale (0=no laxity, 4=maximum laxity) after choosing the order of the before-and-after photo sets. A patient satisfaction survey was also administered.
RESULTS AND DISCUSSION: The two graders correctly ordered 10 of 14 photo sets in agreement. Average rated improvement was 0.75 and 0.80 for graders 1 and 2, respectively. Patient survey results revealed average perceived tightening of 2.14 points on a 0 to 4 scale (0=lowest tightening result, 4=highest tightening), and 8 of 14 subjects would recommend treatment to others.
CONCLUSION: Transdermal monopolar RF is a safe and effective modality for non-invasive body slimming.
J Drugs Dermatol. 2015;14(11):1272-1278.
Andrew F. Alexis| |
Comprehensive Thermoregulation for the Purpose of Skin Tightening Using a Novel Radiofrequency Treatment Device: A Preliminary Report
Douglas J. Key MD| |
METHODS: A retrospective chart review of 18 subjects undergoing thermistor-controlled subdermal skin tightening via percutaneous radiofrequency was conducted. During the treatment, epidermal temperature was concurrently monitored by a handheld infrared laser thermometer and a forward looking infrared camera system and peak temperatures readings were reported and evaluated.
RESULTS: Mean temperatures of 43.6 and 38.2oC were reported for the infrared camera and infrared thermometer. The Bland-Altman plot analysis reported a bias of 5.38oC and 95% limits of agreement between 0.60 and 10.15oC. Additionally, the mean difference or bias of 5.38oC was statistically significant (P less than 0.0001).
CONCLUSION: Our preliminary data supports a superior form of thermoregulation for the purposes of skin tightening that integrates continuous subsurface and epidermal temperature monitoring.
J Drugs Dermatol. 2014;13(2):185-189.
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.
Whitney Bowe MD and Mary-Margaret Kober MD| |
Leopoldo Duailibe Nogueira Santos MD and Jerry Shapiro MD FRCPC| |
Evaluation of a Novel Anti-Aging Topical Formulation Containing Cycloastragenol, Growth Factors, Peptides, and Antioxidants
Robert A. Weiss MD FAAD FACPh and Margaret A. Weiss MD| |
METHODS: Twenty subjects were enrolled in a 12-week, open-label, patient-assessment study. Subjects used a gentle cleanser, cycloastragenol, growth factors, peptides, and antioxidants (Regeneration Booster™, Jan Marini Skin Research (San Jose, CA) and a broad spectrum SPF for the duration of the 12-week study. Assessments were taken at baseline, 2, 4, 8, and 12 weeks. All assessments were compared against baseline for statistical significance.
RESULTS: Eighteen of the twenty subjects completed the 12-week study. Improvement was significant after just 2 weeks of use for all measured categories except erythema and significant for all categories at 12 weeks. One hundred percent of study subjects noted improvement in at least 3 or more of the 8 assessed categories with an average improvement in 6.7 categories. Improvement response rate for individual categories ranged from 67% to 100% of study subjects. There were zero cases of sensitivity or irritation and product smell, feel and ease of application were rated “positive” by 100% of study subjects. Photographic improvement was most notable in texture and lines on the cheeks and eye area.
CONCLUSION: Regeneration Booster, when used as a stand–alone anti-aging solution, delivers rapid and significant reduction in the visible signs of aging. Subject satisfaction was extremely high and there were zero reported cases of sensitivity or irritation. Based on these observations, Regeneration Booster is a safe and effective topical product for individuals seeking significant improvement in the appearance of aging skin.
J Drugs Dermatol. 2014;13(9):1135-1139.
Comparison of the Cutaneous Thermal Signatures Over Twenty-Four Hours With a Picosecond Alexandrite Laser Using a Flat or Fractional Optic
Emil A.Tanghetti MDa and Danielle M.Tartar MD PhDb| |
Vineet Mishra MD,a Lee Miller MD,b Salman M. S. Alsaad MD,c and E. Victor Ross MDb| |
METHODS: Five female patients (age range, 30-60) with abdomen striae alba (n=4) and striae rubra (n=1) were enrolled in the study. Skin type distribution among the 5 patients was two type II, one type III, and two type IVs. The device (Accent XL, Alma Lasers Inc.) is a radiofrequency fractional platform (40.68 MhZ) that deploys multiple conical pin electrodes on a moving handheld 6 cogs roller. Four treatments were performed every two weeks with settings based on test spots performed two weeks prior to a full treatment session. Assessment of striae was based on clinical severity of the lesions on a 1-4 scale, with “4” being the most severe. A questionnaire was administered to patients with possible subjective responses ranging from 0-4, with 0 being no improvement and quartiles from 1-4 (1= mild improvement, 2= fair improvement, 3= moderate improvement, and 4= marked improvement, respectively).
RESULTS: Three months after 4 treatments, a mean improvement of 20% was achieved (mean severity score changed from 2.9 to 2.5). Micro-wounds were approximately 200 μm wide on the surface, initially presenting as small gray “dots” and evolving into black dots lasting about 2 weeks. Mean pain was 2/10. Erythema and edema persisted for about one day. No pigmentation abnormalities were observed at the final evaluation. The results from the patient questionnaire revealed a mean score of 2.4/4, thus falling in the range of good to very good.
CONCLUSION: A fractional ablative micro-plasma RF roller device can improve improvement in the appearance of abdomen striae.
J Drugs Dermatol. 2015;14(11):1205-1208.
Amy E. Rose MD| |
A Clinical Evaluation of a Next Generation, Non-Invasive, Selective Radiofrequency, Hands-Free, Body-Shaping Device
Nicole Hayre MD,a Melanie Palm MD,b and Peter Jenkin MDc| |
Comparison Between Sequentional Treatment With Diode and Alexandrite Lasers Versus Alexandrite Laser Alone in the Treatment of Hirsutism
Laser systems that are commonly used for the treatment of hirsutism include the ruby laser (694 nm), the diode laser (800 nm), the alexandrite laser (755 nm) and the Nd:YAG laser (1084 nm). The diode laser and alexandrite laser are considered effective in treatment of hirsutism in dark-skinned patients. The response of hairs to these laser systems is variable and not complete. In this study, we compared the efficacy of these two laser systems for permanent hair removal. This was a randomized, controlled clinical trial that was performed with women of the age range 15−45 years old. After obtaining informed consent, the samples were randomized into two groups using random allocation software. The first group was treated with alexandrite laser alone (four sessions, two months apart). The second group was treated sequentially with diode laser for the first two sessions and alexandrite laser for the next two sessions. Overall, 111 patients (57 patients in the alexandrite laser group and 54 patients in the sequential diode-alexandrite laser group) were evaluated. There was no significant difference regarding mean of hair reduction between the two groups during the courses of treatment. Except for the first session, there was no significant difference regarding percent of patient satisfaction between the two groups (P value >0.05). Comparison between the two groups showed no significant difference one month, three months and six months after the last treatment (P value >0.05). Regarding the results of our study, there is no significant difference between sequential treatment with diode and alexandrite lasers versus alexandrite laser alone in the treatment of hirsutism. We suggest that in further studies, the efficacy of sequential treatment with other laser systems is evaluated against single treatment methods.
J Drugs Dermatol. 2011;10(11):1255-1259.
Andrew S. Dorizas MD,a Amer H. Nassar MD,a and David J. Goldberg MDb,c| |
EVIDENCE REVIEW: Evidence gathered from a pivotal study involving 1,383 patients with 1,831-pigmented lesions. The isolated use of the pediatric population within this study was used to determine the specificity and sensitivity of such a device with comparison to a dermatologists evaluation.
FINDINGS: For all lesions from the assessed pediatric population the biopsy ratio was equivalent for the Multispectral Digital Skin Lesion Analysis device as for the dermatologists when performing as independent reviewers. Furthermore analyzed data suggests that dermatologists who incorporate the Multispectral Digital Skin Lesion Analysis device perform better than they would independently or if they were to follow the device blindly without incorporating their own judgment.
CONCLUSION AND RELEVANCE: An approach that integrates automated imaging technology like the Multispectral Digital Skin Lesion Analysis device, along with another diagnostic aid, with the end result being cost-effective, easy to use by even non-experts and comforting for the pediatric patient is likely to compete to be the new gold standard in successful early diagnosis and management of melanoma.
J Drugs Dermatol. 2014;13(10):1269-1273.
Leon H. Kircik MD| |
J Drugs Dermatol. 2013;12(11):1268-1270.
Neocollagenesis in Deep and Superficial Dermis by Combining Fractionated Q-Switched ND:YAG 1,064-nm With Topical Plant Stem Cell Extract and N-Acetyl Glucosamine: Open Case Series
Kavita Beri MDa and Sandy S. Milgraum MDb| |
METHOD: Six healthy females (Skin types III - V) were selected for the study with mean average age of 56 years +/- 11 years. The rhytides on the face and neck were assessed using a comprehensive grading scale. Patients were then divided into two groups, one received only laser treatment with the fractionated QSW 1,064 nm laser and the other group received combined treatment with the laser and topical. Patients were assessed again at 4 and 8 weeks.
RESULTS: We observed an enhanced anti-aging effect of the laser in the patients with combined treatment.
DISCUSSION: Understanding the effect of this novel laser therapy on human stem cells and investigating the basis of its synergistic effect with plant stem cell extract and NAG will lead us to better understand stem cell activity. Non-ablative tissue regeneration is the next step in providing optimal anti-aging treatments.
J Drugs Dermatol. 2015;14(11):1342-1346.
Deborah S. Sarnoff MD FAAD FACP| |
Objective Melanin Measurements: Review of Novel Dosimetry Guidance Device for Intense Pulsed Light in Aesthetic Treatments
E. Victor Ross MD,a Travis W. Blalock MD,a Douglas Winstanley DO,a Joel L. Cohen MD,b and James J. Childs PhDc| |
METHODS: A handheld meter was applied to non sun-damaged skin on the back of volunteers to measure skin pigmentation prior to treatment with IPL light sources over a range of pulse widths and ascending fluences. Curves for maximum epidermal tolerances as a function of pigmentation were determined. These curves were then tabulated for each pulse width in device software to provide guidance in the selection of fluences. Based on these findings, the device was applied in over 300 patients at a comprehensive laser and cosmetic dermatology center.
RESULTS: A pigment meter evaluation led to treatment parameter guidance in intense pulsed light applications. These suggested ranges for settings based on the melanin index score proved useful, accurate, and safe in applications over a broad range of skin colors and across various anatomic units of the skin.
CONCLUSION: A pigment meter can be used to identify appropriate settings with IPL treatments in order to enhance safety and efficacy when treating epidermal pigmented lesions, vessels, general photodamage and excessive hair (where the principles of selective photothermolysis are applied).
J Drugs Dermatol. 2016;15(4):421-432.
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.
J Drugs Dermatol. 2012;11(9):e10-e17.
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.
C. Stanley Chan MDa and Jeffrey S. Dover MDa-c aSkinCare Physicians, Chestnut Hill, MA bDepartment of Dermatology, Yale University School of Medicine, New Haven, CT cDepartment of Surgery, Dartmouth Medical School, Hanover, NH| |
J Drugs Dermatol. 2013;12(3):366-367.
Hernan Pinto MDa and Luis G. Garrido MDb,c| |
J Drugs Dermatol. 2013;12(3):322-326.
Virtually Painless Local Anesthesia: Diluted Lidocaine Proves to Be Superior to Buffered Lidocaine for Subcutaneous Infiltration
Background: Many physicians believe that buffering local anesthetics with sodium bicarbonate is the best technique for reducing the pain and discomfort associated with subcutaneous infiltration.
Objective: To compare the level of pain and discomfort associated with subcutaneous infiltration of lidocaine diluted with normal saline to that associated with traditionally buffered lidocaine.
Patients/Methods: In a prospective, double-blind trial, 31 patients were asked to use a visual analog scale to rank the level of pain and discomfort caused by two different solutions of lidocaine with epinephrine. Solution A: 3 mL of 1% lidocaine + epinephrine in 30 mL of bacteriostatic 0.9% sodium chloride in a 1:10 ratio, in which each mL contained 9 mg of sodium chloride and 9 mg of benzyl alcohol. Solution B: 5 mL of 8.4% sodium bicarbonate solution and 50 mL of 1% lidocaine + epinephrine in a 1:10 ratio.
Results: Twenty-eight out of 31 patients reported that the solution of lidocaine diluted with normal saline was the least painful upon injection.
Conclusion: Pain and discomfort during subcutaneous injection of lidocaine can be reduced by diluting the anesthetic with normal saline in a 1:10 ratio.
J Drugs Dermatol. 2012;11(10):e39-e42.
Contactless Abdominal Fat Reduction With Selective RF™ Evaluated by Magnetic Resonance Imaging (MRI): Case Study
Jeanine Downie MDa and Miroslav Kaspar MDb| |
MATERIALS AND METHODS: Six subjects were treated by a contactless selective radiofrequency device (BTL Vanquish ME, BTL Industries Inc., Boston, MA). The MRI fat thickness was measured at the baseline and at 4-weeks following the treatment. In addition to MRI images and measurements, digital photographs and anthropometric evaluations such as weight, abdominal circumference, and caliper fat thickness measurements were recorded. Abdominal fat thickness measurements from the MRI were performed from the same slices determined by the same tissue artefacts.
RESULTS: The MRI fat thickness difference between the baseline measurement and follow up visit showed an average reduction of 5.36 mm as calculated from the data of 5 subjects. One subject dropped out of study due to non-study related issues. The results were statistically significant based on the Student’s T-test evaluation.
CONCLUSIONS: Magnetic resonance imaging abdominal fat thickness measurements seems to be the best method for the evaluation of fat thickness reduction after non-invasive body shaping treatments. In this study, this method shows average fat thickness reduction of 5.36 mm while the weight of the subjects didn’t change significantly. A large spot size measuring 1317cm2 (204 square inches) covers the abdomen flank to flank. The average thickness of 5.36 mm of the fat layer reduced under the applicator translates into significant cumulative circumferential reduction. The reduction was not related with dieting.
J Drugs Dermatol. 2016;15(4):491-495.
Histological and Electron Microscopic Analysis of Fractional Micro-Plasma Radio-Frequency Technology Effects
Fan Xin MD PhD,a Liu Li-hong MD,a Macrene Alexiades-Armenakas MD PhD,b
Stefanie Luebberding PhD,b Shi Cui-ping MD,a Han Yue MD,a An Yu-xi MD,aYue Dan-xia MD,a
and Yang Rong-ya MD PhDa
METHODS: Thirty guinea pigs were randomly selected and were distributed into three treatment groups: 40W/10KJ, 60W/10KJ, and 80W/10KJ. The treated skin was analyzed immediately, one week and one month post-treatment using histology and transmission electron microscope (TEM).
RESULTS: At 40W/10KJ, the epidermis was intact and light collagen homogenization was observed in the papillary dermis. At 60W/10KJ, the epidermis showed focal emergence of fractional shape change and obvious papillary dermal homogenization. At 80W/10KJ, the epidermis was completely vaporized and the superficial and mid-dermal layers of collagen tissue showed a large area of homogenization. Dermal collagen increased in density and became arranged in an orderly manner after one week and markedly thickened and arranged in compact manner after one month. TEM showed that epidermal cells were relatively complete, intercellular structure was normal, but the dermal collagen lost its typical structure, cell structure disappeared and showed massive apoptosis. A low level of apoptosis marker expression was observed, with collagen structure restoration after one month.
CONCLUSION: The treatment with the novel micro-plasma radio-frequency technique has a dose-dependent effect on the skin, especially on the dermal collagen tissue, where neocollagenesis is stimulated.
J Drugs Dermatol. 2013;12(11):1210-1214.
Anti-Inflammatory Activities of Colloidal Oatmeal (Avena sativa) Contribute to the Effectiveness of Oats in Treatment of Itch Associated With Dry, Irritated Skin
Kurt A. Reynertson PhD, Michelle Garay MS, Judith Nebus MBA, Suhyoun Chon PhD, Simarna Kaur PhD,
Khalid Mahmood PhD, Menas Kizoulis BA, Michael D. Southall PhD
METHODS: Four extracts of colloidal oatmeal were made with various solvents and tested in anti-inflammatory and antioxidant assays. In addition, an investigator blind study was performed with twenty-nine healthy female subjects who exhibited bilateral mild to moderate itch with moderate to severe dry skin on their lower legs. Subjects were treated with a colloidal oatmeal skin protectant lotion.
RESULTS: Extracts of colloidal oatmeal diminished pro-inflammatory cytokines in vitro and the colloidal oat skin protectant lotion showed significant clinical improvements in skin dryness, scaling, roughness, and itch intensity.
CONCLUSIONS: These results demonstrate that colloidal oat extracts exhibit direct anti-oxidant and anti-inflammatory activities, which may provide the mechanisms for observed dermatological benefits while using the colloidal oatmeal skin protectant lotion.
J Drugs Dermatol. 2015;14(1):43-48.
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.
Prospective Evaluation of the Safety and Efficacy of a 1060-nm Large Spot Size, Vacuum-Assisted Hair Removal Diode Laser System in Asian/Pacific Fitzpatrick’s Skin Types IV-V Patients
Sushil T.Tahiliani MD and Harsh S.Tahiliani MD| |
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| |
J Drugs Dermatol. 2012;11(4):528-529.
David McDaniel MD,a Klaus Fritz, MD,b,c Alena Machovcova MD PhD MBA,d,e and Jan Bernardy PhDf| |
METHODS: A non-invasive monopolar RF device with cooling (Exilis Elite, BTL Industries, Framingham, MA) was used to reduce abdominal fat in a porcine model. The study was done on 3 Vietnamese pigs in a certified veterinary facility. The treatment was delivered to an area the size of 20 x 10cm. The treatment duration was 11 minutes, 30 seconds. Biopsy samples were taken before the first treatment, 1 hour post each treatment, as well as 8 and 20 hours post each treatment. Programmed cell death (apoptosis) was monitored using the TUNEL method. The temperature was measured on the skin surface by an infrared thermal imager and built-in IR thermometer, and by an internal probe inserted into various depths of the subcutaneous layer. The internal probe placement was monitored by diagnostic ultrasound examination.
RESULTS: The temperature in the treated adipose tissue was higher compared to the skin surface temperature. The average temperature gradient observed was 3.1°C. Due to the temperature gradient the skin surface remained intact, while subcutaneous layers showed significant changes. The TUNEL method proved large-scale apoptosis of fat cells after each treatment. The apoptotic index increased from 7% before the first treatment to an average of 53.4%, 39.6%, 40.2%, and 44.7% respectively for each treatment. In the three-month follow up the apoptotic index dropped back to 11.7%. Histology, blood biochemistry and hematology samples showed mild to no signs of inflammation in the treated area.
CONCLUSION: The study has shown that use of monopolar, focused radiofrequency can induce substantial apoptotic process in a porcine model. The data suggests that the monopolar, focused radiofrequency device can be used for reduction of fat and body shaping.
J Drugs Dermatol. 2014;13(11):1336-1340.
Evaluation of the Safety and Efficacy of a Novel 1440nm Nd:YAG Laser for Neck Contouring and Skin Tightening Without Liposuction
Deborah S. Sarnoff MD FAAD FACP| |
OBJECTIVE: To test the safety and efficacy of a pulsed 1440nm Nd:YAG wavelength and side-firing fiber for the treatment of subcutaneous fat and skin laxity associated with the aging neck.
METHODS: Twenty-four subjects aged 40 to 65 years underwent laser lipolysis of the submental and anterior cervical areas. An average of 1205J per 5x5cm square was delivered, with a maximum internal temperature setting of 47 degrees C. Cervicomental Angle Score (CAS), Global Aesthetic Improvement Scale (GAIS), subject and investigator satisfaction, and safety were assessed.
RESULTS: At six months post-treatment, 79% of subjects had a significant improvement in the CAS (P<.001) and 79% demonstrated an improvement on the GAIS. Clinical improvement was marked and evident for all but one subject, with physician and patient satisfaction scores indicating overall satisfaction with the procedure and outcomes. Adverse events were mild and transient with no incidence of burns, seromas, hematomas, infection, or nerve damage.
CONCLUSION: The 1440nm Nd:YAG device with the side-firing fiber was safe and effective for the treatment of subcutaneous fat and skin laxity in the neck. This device offers an alternative to selected individuals aged 40 and over who do not wish to undergo rhytidectomy.
J Drugs Dermatol. 2013;12(12):1382-1388.
J Drugs Dermatol. 2011;10(5):494-498.
Fractional, Nonablative Q-switched 1,064-nm Neodymium YAG Laser to Rejuvenate Photoaged Skin: A Pilot Case Series
Methods: Seven healthy female subjects (mean ±standard deviation age, 53.8 ± 10.0 years) with visible signs of facial and neck skin aging were treated with fractional, nonablative Q-switched 1,064-nm Nd:YAG laser device (Pixel QS Nd:YAG; Alma Lasers Ltd, Caesarea, Israel). Treated areas were the face, including the periorbital and perioral regions (particularly the upper lip), neck, and chest. Treatments consisted of 3 sessions at 2- to 4-week intervals. Follow-up was performed monthly following the final treatment. The Alexiades-Armenakas Comprehensive Grading Scale of Skin Aging was employed to assess efficacy. Pain ratings were recorded by 10-point visual assessment scoring.
Results: Employing the validated, quantitative grading scale for rhytides of the face and neck, a 0.29 grade improvement, or 11.3% improvement, over baseline grade was observed in the 7-subject cohort that completed follow-up following a mean of approximately 2 treatments at approximately 1-month follow-up. No pain and rapidly resolving minimal erythema were noted in all subjects during treatment.
Conclusion: The results of this pilot case series suggest that the treatment with the fractional, nonablative Q-switched 1,064-nm Nd:YAG laser device significantly improves superficial rhytides. With its outstanding safety, it seems to be particularly suitable for the treatment of sensitive areas, such as the periorbital region, lips, neck, and chest. The Q-switched Nd:YAG laser is a facile, safe, and fast treatment for aesthetic skin rejuvenation.
J Drugs Dermatol. 2012;11(11):1300-1304.
The Evolution of Injectable Poly-L-Lactic Acid From the Correction of HIV-Related Facial Lipoatrophy to Aging-Related Facial Contour Deficiencies
Cheryl Burgess MD| |
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.
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.
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.
Efficacy of Tofacitinib for the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis in Patient Subgroups from Two Randomised Phase 3 Trials
M. Alan Menter MD,a Kim A. Papp MD,b Jennifer Cather MD,c Craig Leonardi MD,d David M. Pariser MD,e
James G. Krueger MDM,f Johannes Wohlrab MD,g Mario Amaya-Guerra MD,h Andrzej Kaszuba MD,i
Oleg Nadashkevich MD,j Tsen-Fang Tsai MD,k Pankaj Gupta PhD,l Huaming Tan PhD,l
Hernan Valdez MD,m Lotus Mallbris MD,n and Svitlana Tatulych MDl
OBJECTIVES: To assess consistency of treatment effects of tofacitinib versus placebo in subgroups defined by baseline characteristics, and to ascertain whether baseline characteristics are of value in optimizing tofacitinib use.
METHODS: Pooled data from the two trials were used to evaluate ≥75% reduction in PASI from baseline (PASI75 response) in subgroups defined by age, age at psoriasis onset, gender, race, geographical region, weight, body mass index, diabetes, metabolic syndrome, tobacco/alcohol use, psoriatic arthritis, disease activity, and prior therapy.
RESULTS: Week 16 PASI75 response rates (N=1843) were 43%, 59% and 9% with tofacitinib 5 and 10mg twice daily (BID) and placebo, respectively (each P<0.0001 versus placebo). Tofacitinib 5 and 10mg BID were effective regardless of baseline characteristics. Across subgroups, tofacitinib generally produced greater response rates with the 10 versus 5mg BID dosage. Lower absolute response rates were seen in heavier patients and patients with prior biologic experience.
CONCLUSIONS: Both tofacitinib dosages demonstrated consistent efficacy versus placebo across subgroups. Lower response rates were seen in heavier patients and those with prior biologic experience. Tofacitinib 10mg BID resulted in a substantial proportion of responders regardless of baseline characteristics.
J Drugs Dermatol. 2016;15(5):568-580.
Ablative Fractionated CO2 Resurfacing Yields Excellent Result for Severely Atrophic Traumatic Scar on the Face
J. Daniel Jensen MD, Cooper Keane MD, Conway C. Huang MD, and Marian E. Northington MD| |
J Drugs Dermatol. 2014;13(7):861-862.
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.
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 Review of Clinical Trials Conducted With Oral, Multicomponent Dietary Supplements for Improving Photoaged Skin
Jay Birnbaum PhD,a Anne Le Moigne,b Lisa Dispensa MS RD,c and Larry Buchner BAd| |
J Drugs Dermatol. 2015;14(12):1453-1461.
Amy Forman Taub MDa,b and Ann Cameron Schieber PA-Ca| |
J Drugs Dermatol. 2015;14(11):1329-1334.
Deborah S. Sarnoff MD| |
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| |
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.
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(4):466-470.
Omar A. Ibrahimi MD PhD,a Robert A. Weiss MD,b Margaret A. Weiss MD,b Christian R. Halvorson MD,b Flor Mayoral MD,c E. Victor Ross MD,d and Joel L. Cohen MDe| |
J Drugs Dermatol. 2015;14(9):1065-1068.
Z. Paul Lorenc MD FACS,a Thomas Greene MD,b and Ronald W. Gottschalk MD FAAD FRCPCc| |
J Drugs Dermatol. 2016;15(6):759-762.
Alan R. Shalita MD, Guy F. Webster MD PhD, Mitchell S. Wortzman PhD, Diane Nelson BSN MPH| |
Leon H. Kircik MD| |
J Drugs Dermatol. 2012;11(11):1316-1230.
A Proposed Method for Upper Eyelid and Infrabrow Tightening Using a Transcutaneous Temperature Controlled Radiofrequency Device With Opaque Plastic Eye Shields
Douglas J. Key MD and Lauren Boudreaux DO| |
A Single-Center, Randomized Double-Blind, Parallel-Group Study to Examine the Safety and Efficacy of 3mg Drospirenone/0.02mg Ethinyl Estradiol Compared With Placebo in the Treatment of Moderate Truncal Acne Vulgaris
Ma. Beatrice Alora Palli MD,a,b Claire Marie Reyes-Habito MD,b Xinaida T. Lima MD MPH,c and Alexa B. Kimball MD MPHa,b| |
OBJECTIVE: In this study, we sought to evaluate the safety and efficacy of 3mg DRSP/0.02mg EE versus placebo in the treatment of truncal acne in women.
METHODS: Females, age 18-45, with 10 to 50 truncal acne lesions, were randomized in this double-blind study to 3mg DRSP/0.02mg EE (n=15) or placebo (n=10) administered in a 24/4 regimen given for 24 weeks. Noninflammatory, inflammatory and total truncal acne lesion counts were assessed from baseline to endpoint and mean percent change compared. Investigator Global Assessment (IGA) and Subject Global Assessment (SGA) were assessed based on scoring scales, and the percentage of subjects rated as success with clear (score 0) or almost clear (score 1) were computed.
RESULTS: The 3mg DRSP/0.02mg EE group had significant reductions in mean percent change in noninflammatory, inflammatory and total lesions by 52.1%, 53.2%, and 57.3%, respectively, compared to placebo with -9.2%, 18.2% and 17.0 %, respectively, by week 24 (p = 0.02, 0.05 and 0.02, respectively). The percentage of subjects on 3mg DRSP/ 0.02mg EE rated as treatment success were 53.3% and 60% based on IGA and SGA respectively. The regimen was also well tolerated by patients.
CONCLUSIONS: 3mg DRSP/ 0.02 mg EE is a safe and significantly effective treatment for moderate truncal acne.
J Drugs Dermatol. 2013;12(6):633-637.
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.
Efficacy and Safety of Azelaic Acid (AzA) Gel 15% in the Treatment of Post-Inflammatory Hyperpigmentation and Acne: A 16-Week, Baseline-Controlled Study
Leon H. Kircik, MD| |
J Drugs Dermatol. 2011;10(6):586-590.
Qiuhong Yang MS,a* Daniel J. Aires MD JD,b* Shuang Cai PhD,a Garth R. Fraga MD,b
Da Zhang MD,b Cicy Z. Li MS,b and M. Laird Forrest PhDa
METHODS: Human melanoma cell line A-2058 tumor cells were injected into athymic mice. After tumors grew to 50~100 mm3 mice were divided into five groups: (1) nontreated (2) intravenous (i.v.) cisplatin, (3) i.v. nano hyaluronan-conjugated cisplatin (HA-Pt), (4) subcutaneous (s.c.) peri-tumoral cisplatin, and (5) s.c. peri-tumoral HA-Pt. All treatment groups received 3 weekly doses of 10 mg/kg.
RESULTS: Tumors grew progressively in all control, i.v. cisplatin, and s.c. cisplatin groups. Tumors showed a trend toward slower growth in the i.v. HA-Pt group, but all animals died or were euthanized per protocol within 3 weeks of treatment. Tumors showed shrinkage only in the subcutaneous peri-tumoral HA-cisplatin group; one of these mice appeared to be cured.
CONCLUSIONS: Peri-tumoral HA-cisplatin may be shown potential as a therapeutic option in treatment of certain types of melanoma.
J Drugs Dermatol. 2014;13(3):283-287.
Optical Coherence Tomography Imaging of Erythematotelangiectatic Rosacea During Treatment With Brimonidine Topical Gel 0.33%: A Potential Method for Treatment Outcome Assessment
Jennifer Urban BS,a Arunee H. Siripunvarapon MD,b Adam Meekings BS,c
Amy Kalowitz BS,b and Orit Markowitz MD FAADb
OBJECTIVE: To examine and describe how OCT skin morphology changes when exposed to brimonidine topical gel 0.33% in the treatment of erythematotelangiectatic rosacea.
METHODS: Normal in vivo telangiectasias and erythematous patches and papules were examined prior to treatment clinically, dermatoscopically, and through OCT scans. Brimonidine topical gel 0.33% was applied to the face and OCT images were acquired at defined time intervals: baseline; immediately (<5 minutes) after application; 4 hours after application; and after 2 weeks’ once daily application. OCT morphology was then described.
RESULTS: OCT imaging showed an increase in the mean gray value (MGV), a measure of dermal reflectivity, corresponding to a decrease in dermal edema. MGV measurements for the nasal telangiectasia were: baseline, MGV 10,471 (standard deviation [SD] 6,847); immediate, MGV 15,634 (SD 8,983); after 4 hours, MGV 16,357 (SD 7,647); and after 2 weeks, MGV 15,505 (SD 6,870). MGV measurements for the chin erythema were: baseline, MGV 8,850 (SD 4,969); immediate, MGV 10,799 (SD 5,266); after 4 hours, MGV 12,419 (SD 6,714); and after 2 weeks, MGV 13,395 (SD 6,170). No significant change in vessel lumen diameter was appreciated. Vessel lumen diameter for the facial papule ranged from 0.13 mm at baseline, 0.09 mm immediately after treatment, 0.09 mm after 4 hours, and 0.11 mm after 2 weeks.
CONCLUSIONS: OCT scanning showed a decrease in the dermal hyporeflectivity of the dermis consistent with a decrease in dermal edema. The OCT scans obtained did not show any significant change in vessel lumen diameter. These results may reflect an increase in vascular tone, which can be attributable to the clinical improvement and decreased erythema noted in the patient. This technology could potentially be used for the non-invasive in vivo monitoring of other topical treatments.
J Drugs Dermatol. 2014;13(7):821-826.
John Ferguson MD| |
METHODS: Percutaneous subdermal RF treatment was performed on 48 samples of abdominoplasty tissue; samples were marked to standardize measurement of surface area in the treatment zones, and a subdermal temperature target of 51°C was preprogrammed into the treatment device. The treatment cannula was inserted parallel to the dermal plane at four points with a single pass per insertion. Surface area was then re-measured.
RESULTS: Approximate average reduction in surface area was 91.23±19.33 mm2, ranging between 124.45 mm2 and 35.39 mm2 (median 96.83 mm2). Results were statistically significant (P<0.0001). Statistical analysis via analysis of variance (ANOVA) plus Tukey post-hoc testing revealed no statistically significant difference between the sides in all comparisons, demonstrating symmetry in contracture.
CONCLUSION: Percutaneous subdermal monopolar RF creates dramatic, immediate tissue contraction in vitro and is a viable technology for tissue tightening.
J Drugs Dermatol. 2016;15(1):55-58.
Laura Jordan OMS4 MS MA MLS,a Sarah Malerich DO,b Summer Moon DO,c James Spencer MDd| |
J Drugs Dermatol. 2014;13(9):1099-1103.
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| |
Oge C. Onwudiwe MD,a Ellen S. Marmur MD,b and Joel L. Cohen MDc| |
J Drugs Dermatol. 2013;12(2):199-205.
A Randomized, Phase 2, Dose-Ranging Study in the Treatment of Moderate to Severe Inflammatory Facial Acne Vulgaris With Doxycycline Calcium
James J. Leyden MD,a Suzanne Bruce MD,b Chai Sue Lee MD,c,* Mark Ling MD PhD,d Pranav B. Sheth MD,e Daniel M. Stewart DO,f William P. Werschler MD,g Richard D. Gilbert PhD,h and Leon Kircik MDi| |
METHODS: This was a randomized, double-blind, phase 2 dose-ranging study in subjects with moderate to severe inflammatory acne aged 12 years to 45 years. Subjects were randomized to receive doxycycline calcium tablets 0.6, 1.2, or 2.4 mg/kg/day or placebo, and instructed to take their tablets once daily for 12 weeks, in the evening at least 1 hour before or 2 hours after mealtime. The primary efficacy variables were the dichotomized Investigator's Global Assessment score (success or failure) at week 12 (success defined as ≥2 score decrease from baseline) and the absolute change from baseline to week 12 in inflammatory lesion count.
RESULTS: A dose-response effect was seen with doxycycline calcium formulation in subjects with moderate to severe inflammatory acne. The highest dose-group (corresponding to approximately 2.4 mg/kg/day) showed a statistically significant difference from placebo. The dose-response effect was confirmed by logistic regression analysis for both treatment success and incidence of gastrointestinal adverse events. A limitation of this study is that safety and efficacy were only studied on moderate to severe inflammatory acne. Also, the study was not prospectively powered to show efficacy differences.
CONCLUSION: Doxycycline calcium shows a dose-response effect in reducing inflammatory lesions in subjects with moderate to severe inflammatory acne.
J Drugs Dermatol. 2013;12(6):658-663.
Application of a Topical Biomimetic Electrical Signaling Technology to Photo-Aging: A Randomized, Double-Blind, Placebo-Controlled Trial of a Galvanic Zinc-Copper Complex
Jeannette Chantalat MS MBA, Elizabeth Bruning BSC LLB, Ying Sun PhD, Jue-Chen Liu PhD| |
Objectives: To evaluate the efficacy and tolerability of a galvanic zinc-copper complex on photo-aging parameters in a randomized, double-blind, placebo-controlled clinical trial.
Materials and Methods: In this eight-week study, women (40-65 years) with mild to moderate photo-aging were randomized to use placebo or 1 of 3 galvanic zinc-copper complex compositions (gel and activating moisturizer). Efficacy evaluations included clinical grading, specialized clinical imaging, and subject self-assessments performed at baseline, 15-30 minutes after product application and after 1, 2, 4, and 8 weeks. Tolerability was based on adverse events and clinical grading of irritation. Significance was set at P≤0.05 versus baseline and between treatment groups.
Results: The study was completed by 124 women. Compositions containing the galvanic zinc-copper complex showed statistically significant clinical improvements versus placebo and baseline rapidly (15-30 min) after application and through week 8. Clinical grading showed significant improvement versus placebo in skin radiance and under-eye dark circles 15-30 minutes after first application with continued improvement through week 8, and in overall photo-damage, fine lines, lifted appearance of the eyes, and under-eye wrinkles starting after two weeks and continuing through week 8. Test compositions were well tolerated.
Conclusion: This galvanic zinc-copper complex provided rapid and lasting improvements versus placebo in photo-aged skin, supporting its use in topical anti-aging formulations.
J Drugs Dermatol. 2012;11(1):30-37.
A Comparison of Physicochemical Properties of a Selection of Modern Moisturizers: Hydrophilic Index and pH
Material and Methods: The pH and hydrophilic fraction of 31 skin moisturizers sold in the US were measured. Hydrophilic Index (HI) was calculated using the "HI equation." The two parameters were charted using a scatter plot with quadrant divisions. Products with lower hydrophilicity were considered "more greasy" and assigned a lower HI as compared to their counterparts with a higher hydrophilicity.
Results: Our findings are in good accordance with common clinical impressions: lotions generally have higher HI, while ointments have lower HI. The majority of the products tested fall into low HI, suggesting that a large percentage of the products may be rich in overall lipid content. The pH values range widely, from 3.7 to 8.2, with the majority of the products close to the physiologic skin pH of 4 to 6.
Conclusion: This study introduces HI as a novel method of quantifying the aqueous content of topical emollients. When considered together with pH, the two indices can guide providers in choosing the most suitable emollients for patients with skin diseases involving altered acid mantle and barrier disruption, such as atopic dermatitis, irritant contact dermatitis, and ichthyosis vulgaris.
J Drugs Dermatol. 2012;11(5):633-636.
Timothy P. Wu BA and Jennifer A. Stein MD PhD| |
J Drugs Dermatol. 2013;12(5):568-572.
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| |
Cryosurgical Treatment of Warts: Dimethyl Ether and Propane Versus Liquid Nitrogen -- Case Report and Review of the Literature
Topical Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Maintains Efficacy of Etanercept After Step-Down Dose in Patients With Moderate-to-Severe Plaque Psoriasis: Results of an Open Label Trial
Trial Design: In this single-center, open-label study, subjects (n=20) underwent 12 weeks treatment with etanercept 100 mg/week (50 mg, 2x week; weeks –12 to -1), followed by etanercept 50 mg/week maintenance therapy for 40 weeks (weeks 0 to 40). Subjects were followed at four-week intervals. Starting at week 4, subjects who demonstrated an increase from baseline (week 0) body surface area (BSA) of >2% initiated therapy with calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment for four weeks. The study is limited by its small sample size, open-label nature, and lack of blinding.
Findings: Mean BSA involvement decreased significantly from week –12 to 0 with etanercept 50 mg twice a week. At week 4, on the etanercept 50 mg/week dose, mean BSA increased to 9.42±9.39 compared to week 0. With introduction of calcipotriene 0.005%/betamethasone dipropionate 0.064% ointment at week 4, mean BSA decreased to 4.62±8.19 by week 24 and was relatively stable for the remainder of the study period. Similarly, mean PASI (Psoriasis Area and Severity Index) scores improved from week -12 to week 0, increased at week 4, then decreased significantly by week 24 with adjunctive topical treatment.
Conclusion: Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is a safe and effective adjunct to etanercept 50 mg/week maintenance therapy.
J Drugs Dermatol. 2011;10(8):881-885.
Eric F. Bernstein MD| |
A number of drugs can cause cutaneous hyperpigmentation through a variety of mechanisms. The pigment is comprised of dermal deposits of the drug and its metabolites, often combined with melanin and hemosiderin. Minocycline and amiodarone are among the most common medications to cause skin-induced pigmentation. Affected individuals generally develop slate-gray pigmentation in affected sites. Treatment with various Q-switched lasers has been shown to be effective at removing drug-induced pigmentation. The author presents a man with amiodarone pigmentation of the face who responded to treatment with the Q-switched neodymium:yttrium-aluminum-garnet (Nd:YAG) laser.
J Drugs Dermatol. 2011;10(11):1316-1319.
Zoe Diana Draelos MD,a Jwala Karnik MD,b and Gail Naughton PhDc| |
Jerry Bagel MD| |
Kenneth Beer MD PA and Karen Rothschild JD| |
Hema Sundaram MD FAAD| |
Two Randomized, Controlled, Comparative Studies of the Stratum Corneum Integrity Benefits of Two Cosmetic Niacinamide ⁄ Glycerin Body Moisturizers vs. Conventional Body Moisturizers
Jeremy C. Christman MS,a Deborah K. Fix BS MBA,b Sawanna C. Lucus BS,a Debrah Watson BS,a Emma Desmier BS,a Rolanda J. Johnson Wilkerson PhD,a Charles Fixler MDb| |
Methods: 63 and 58 female subjects were enrolled and randomized in an incomplete block design to six of nine products (eight moisturizers or no treatment control) in studies 1 and 2, respectively. The primary endpoints included visual dryness by a qualified skin grader, skin hydration as measured by Corneometer, and barrier integrity as measured by transepidermal water loss (TEWL). The primary comparisons for the two niacinamide/glycerin moisturizers were to the other six moisturizers and to the no treatment control for each endpoint.
Results: The two niacinamide/glycerin moisturizers demonstrated an overall better solution towards rapid and prolonged improvement of cosmetic xerosis due to functional improvement of stratum corneum barrier function compared to no treatment and the other moisturizers tested.
Conclusions: These studies establish the benefit of including niacinamide in a body moisturizer to improve the integrity of the stratum corneum and thus reduce cosmetic xerosis over time.
J Drugs Dermatol. 2012;11(1):22-29.
In Vivo Histological Evaluation of Non-Insulated Microneedle Radiofrequency Applicator With Novel Fractionated Pulse Mode
Yoram Harth MD FAADa,b and Ido Frank BSc MBAb| |
METHODS: After Ethics Committee approval, one female pig (Type Large white X Landrace, 34 Kg) was chosen for the study. The animal was anesthetized using Ketamine, Xylazin and Isofluran. The EndyMed PRO, Intensif applicator (was used for treatment with different needle depth penetration (1mm-3.5 mm) and in multiple energy settings. Six mm punch biopsies were harvested for histological analysis at the following time points: immediately after the treatment, 4 days after the treatment and 14 days after the treatment. H&E and Masson-Trichrome stains were processed.
RESULTS: Visual inspection of the treated skin, immediately after the treatment, revealed arrays of pinpoint erythematous papules surrounded by undamaged epidermal tissue. Treatment field showed no sign of bleeding. Mild to moderate Erythema and Edema developed a few minutes after the treatment, varying according to the total energy delivered. The histologies taken 4-day after therapy showed in all energy settings, dry micro crusts over the treatment zones, with full healing of epidermis. In the 14-day specimens there was a replacement of the crusts/debris by a normal looking stratum corneum with complete healing of epidermis and dermis.
DISCUSSION: The current in vivo study confirms that the EndyMed PRO Intensif applicator effective and predictable tool to create cylindrical micro zones of coagulation in the papillary and reticular dermis with minimal damage to the epidermis. The histologies taken 4 days and 14 days after treatment show rapid epidermal renewal with predictable volume of coagulation in dermis related to the length of the needle and the power used. Coagulation of capillaries during treatment allows a dry treatment field. The predictability of the effect and minimal downtime may offer a significant advantage over treatments with ablative fractional lasers of insulated RF microneedles.
J Drugs Dermatol. 2013;12(12):1430-1433.
Allogeneic Growth Arrested Keratinocytes and Fibroblasts Delivered in a Fibrin Spray Accelerate Healing in Mohs Micrographic Surgery Wounds
Leon Kircik MD,a-c Jaime E. Dickerson Jr PhD,d,e Christina Kitten,f
Kathy A. Weedon BS,d and Herbert B. Slade MDd,g
METHODS: Open-label, randomized pilot study conducted at a single center. Subjects were randomized to either HP802-247 (5M cells/mL) applied weekly or bacitracin ointment applied daily. Treatment continued for up to 12 weeks or complete wound closure. Primary efficacy was effectiveness as measured by the Investigator’s Global Assessment of Healing (IGAH) scale. Secondary outcomes included median time to healing, investigator- and subject-scored signs and symptoms, and an assessment of scar by the investigator at 16 weeks postsurgery.
RESULTS: All subjects achieved favorable outcomes within the study period; however, these were reached more quickly for the HP802-247 group than for bacitracin. At 3 weeks postsurgery, healing was assessed as very effective for 75% of subjects in the HP802-247 group compared with 50% for bacitracin. Median time to closure was 24.5 days for HP802-247 and 29 days for bacitracin. Scores for signs and symptoms and scar were similar for both groups but, in general, were numerically better for HP802-247.
CONCLUSION: In this small pilot study, HP802-247 was found to provide a modest, incremental benefit in the healing of Mohs micrographic surgery wounds, suggesting that the healing of uncomplicated acute wounds may be slightly accelerated without enhancement of scarring.
J Drugs Dermatol. 2013;12(5):558-561.
Methods: Five patients were enrolled in the study. All patients presented with epidermal pigmented lesions on the arms, hands, chest, or legs. Patients were all female with a mean age of 59 years. At the initial evaluation, baseline pigment readings were determined with a pigment meter. Test spots were performed with escalating doses of alexandrite laser (ClearScan ALX, Sciton, Palo Alto, CA) deployed by a 7-mm spot equipped with a 30 mm x 30 mm scanner and a 10-ms pulse duration. Contact cooling was used, and temperature was maintained at 18°C to 20°C. Patients returned 4 to 7 days after test spots for evaluation for the purpose of optimizing settings. The highest settings that allowed for epidermal preservation and crusting of the hyperpigmented lesions were applied for the remainder of the treatment zones. Determinations of improvement were made by evaluation of photographs with standard settings using polarized and nonpolarized images. At each appointment, baseline pigment measurements were made to ensure there were no significant changes between treatment sessions. Two treatment sessions were performed approximately 4 weeks apart, and the final evaluation was 3 months after the final treatment.
Results: Evaluation by a panel of blind observers determined a mean improvement of approximately 30%. Darker lesions responded better than lighter lesions. So-called low-contrast lesions performed the poorest. Pain was approximately 2/10 with the use of 5% lidocaine numbing cream applied approximately 45 minutes before each procedure. Pain was most severe where there was underlying hair.
Conclusion: A long-pulse alexandrite laser equipped with contact cooling can achieve significant pigmentation improvement.
J Drugs Dermatol. 2012;11(11):1327-1330.
Evaluation of the Safety and Efficacy of a Low Fluence, Picopulsed, Alexandrite Laser in a Pico-Toning Technique With a Diffractive Lens Optic for the Treatment of Photodamage and Textural Improvement in “Off the Face” Applications
Raminder Saluja MD| |
Patrick Micheels MD,a Didier Sarazin MD,b Stéphanie Besse MD,c and Badwi Eliasd| |
J Drugs Dermatol. 2017;16(2):154-161.
Jonathan M. Sykes MD,a Amir Allak MD MBA,a and Brian Klink MDb| |
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.
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.
The Frontalis Activity Measurement Standard: A Novel Contralateral Method for Assessing Botulinum Neurotoxin Type-A Activity
Background: There are conflicting data regarding the specific attributes of botulinum neurotoxin type-A (BoNTA) products including onset of action, duration and spread because accurate, objective methods for assessing their clinical activity are lacking.
Objective: To refine definitions for BoNTA activity utilizing the frontalis muscle and describe the Frontalis Activity Measurement Standard (FMS), an objective method for measuring changes in frontalis muscle activity as a metric for assessing BoNTA pharmacodynamics.
Methods: As part of a study to assess BoNTA activity, 20 subjects with severe frontalis lines at maximum elevation were injected with two BoNTA products at five points on contralateral sides of the frontalis. Changes in maximum baseline frontalis elevation were measured by a blinded investigator using the previously-validated Frontalis Rating Scale (FRS) and the FMS. Frontalis activity endpoints were redefined to include Initial, Full and Complete Onsets of action and Partial, Full and Complete efficacy.
Results: Differences in the onset of effect of the BoNTA products were detected with both the FRS and FMS; however, the FMS detected changes in frontalis activity earlier than the FRS. A significant correlation between the FRS and FMS was documented.
Conclusion:The frontalis muscle activity allows for enhanced assessment of BoNTA activity and attributes. The FMS appears to be a sensitive and objective tool for measuring pharmacodynamic parameters of BoNTA. Refining definitions of BoNTA activity provides a more accurate means for describing the clinical effects of BoNTA.
J Drugs Dermatol. 2011;10(9):968-972.
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.
Randomized, Controlled, Evaluator-Blinded Studies Conducted to Compare the Efficacy and Tolerability of 3 Over-the-Counter Acne Regimens in Subjects With Mild or Moderate Acne
Lawrence Green MD,a Leon H. Kircik MD,b-d and Jennifer Gwazdauskas MBAe| |
Objectives: To compare the efficacy, user satisfaction, and tolerability of the OTC regimens MaxClarity™, Proactiv®, and Murad® in the treatment of mild and moderate acne. Methods: Two randomized, evaluator-blinded, split-face studies were conducted, each involving 20 subjects with acne, to evaluate MaxClarity against Proactiv (study 401) and MaxClarity against Murad (study 404) over 8 weeks.
Results: Clinically and statistically significant reductions in acne lesion counts were achieved at 8 weeks compared with baseline for each regimen using MaxClarity, Proactiv, and Murad. Similar reductions in lesion counts and improvements in Investigator's Static Global Assessment grades were observed between MaxClarity and either Proactiv or Murad, in the respective studies. MaxClarity was well tolerated, with no treatment-related adverse events observed in any treatment group and no discontinuations due to adverse events. Overall, most subjects were satisfied with all study treatments.
Conclusions: MaxClarity is an effective alternative to either Proactiv or Murad for use in the treatment of mild and moderate acne.
J Drugs Dermatol. 2013;12(2):180-185.
Integrated Cooling-Vacuum-Assisted Non-Fractional 1540 nm Erbium:Glass Laser is Effective in Treating Acne Scars
Yael Politi MD,a Assi Levi MD,b,c and Moshe Lapidoth MDa,b,c| |
Patrick Bitter Jr. MD| |
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial of a Novel Nutritional Supplement Product to Promote Healthy Skin
Steven H. Dayan MD,a,b John P. Arkins BS,c Vinny Sharma BS,d Elaine Paterson PhD,e David Barnes PhDf| |
Background: Despite an abundance of nutritional supplements, very few well-controlled trials have assessed their beneficial effect on the skin, such as hydration, antioxidant levels, texture or appearance. The objective of the following placebo-controlled, double-blind study was to determine the effects of the Skin Health Experimental Product (SHEP) on skin health.
Methods: The study enrolled healthy men and women aged 30 years or older. Subjects were randomized to receive a twice-daily regimen of SHEP or placebo. The effects SHEP had on overall skin appearance and health were assessed by measuring improvements in: (1) skin hydration using a closed-aperture transepidermal water-loss moisture meter and a vapometer; (2) skin texture using silicon profilometry; (3) skin carotenoid concentration using Raman spectrometry; and (4) reported self-image assessments using the Global Aesthetic Improvement Scale (GAIS).
Results: SHEP-treated subjects demonstrated a significant reduction in fine lines compared to the placebo-treated group. Raman spectroscopy showed that SHEP increased carotenoids at some measurement sites. Based on the GAIS, SHEP-treated subjects were three times more likely to perceive an improvement in their appearance compared to placebo-treated subjects (P>0.049).
Conclusion: The orally-administered SHEP nutritional supplement improves skin texture, carotenoid levels in specific areas of the hand, and improves patients' perception of skin health.
J Drugs Dermatol. 2011;10(9):1106-1114.
The History Behind the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization: The Positive Impact of Evolving Methodology
Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc| |
J Drugs Dermatol. 2014;13(suppl 4):s32-s34.
Use of Naftifine Hydrochloride 2% Cream and 39% Urea Cream in the Treatment of Tinea Pedis Complicated by Hyperkeratosis
Leon Kircik MDa,b,c and Neh Onumah MDd| |
J Drugs Dermatol. 2014;13(2):162-165.
Integration of Thermal Imaging With Subsurface Radiofrequency Thermistor Heating for the Purpose of Skin Tightening and Contour Improvement: A Retrospective Review of Clinical Efficacy
Douglas J. Key MD| |
METHODS: A retrospective analysis of 35 patients was completed on patients having undergone ThermiTight for submental skin tightening. Treated sites included under-chin and under-chin and jowls. The ThermiTight probe temperature was set between 50 to 60oC and was maintained using the thermistor integrated electrode. The probe was guided at a deliberate pace, treating a surface area of 3.0 cm2 every two minutes. The clinical endpoint was an epidermal temperature of 42oC. Two blinded reviewers assessed photographs taken at baseline and 30 days post-procedure. They were randomly presented with a photograph and asked to rate the photograph using a 4.0 skin laxity scale.
RESULTS: The combined mean change comparing baseline and post-procedure skin laxity scores was -0.78, which was statistically significant (Table 2; P<0.0001). Each blinded reviewer correctly categorized photographs as either being “baseline” or “post-procedure” 89% of the time. No adverse events were reported.
DISCUSSION: These data demonstrate the safety and efficacy of the ThermiTIght procedure for the treatment of skin laxity.
J Drugs Dermatol. 2014;13(12):1485-1489.
Vivian W. Bucay MD FAAD| |
Cuttlefish Ink Melanin Encapsulated in Nanolipid Bubbles and Applied Through a Micro-Needling Procedure Easily Stains White Hair Facilitating Photoepilation
Mario A. Trelles MD PhD,a,* Patricia Almudever PhD,b,* Justo M. Alcolea MD,a
Julio Cortijo PhD,b Gabriel Serrano MD,c Inmaculada Expósito MD,c Josefina Royo MD,d
and Franck Marie Leclère MD PhDe
MATERIAL AND METHODS: Twelve patients, phototypes II-III, with white or very fair hair, were treated with a compound containing melanin encapsulated in nanosomes (Melaser®) together with a fluorescent marker. Two equal 6 cm² areas were marked on each side of the occiput of the subjects. The compound was applied to a randomly selected experimental side on each patient (area A), and a saline solution applied in the same manner to the contralateral control side (area B). Penetration of the melanin into the hair follicle was assessed using optical and fluorescence microscopy. Also, condition of hair structure was checked in vivo after standard laser settings used for epilation.
RESULTS: A slight transient erythema was observed in those areas where the compound was applied with some perifollicular edema. No such effects were noticed in those areas where saline solution was applied. No persistent complications such as scarring, hypo- or hyperpigmentation were observed in any of the experimental or control areas. Under fluorescence microscopy, the hair structures in the areas to which the compound had been applied showed a clear melanin deposit confirmed by the immunofluorescence intensity, which was highest at 2 hours after application. By optical microscopy, external melanin was deposited in hair follicles. Tests with standard settings for epilation were efficacious in damaging melanin-marked white hair.
CONCLUSION: This study strongly suggests the safety and efficacy of the application of nanosomes encapsulating melanin for the introduction of melanin into hair follicles. Changes noticed in the hair structure compromising its viability indicated potential application of this external melanin marker for white hair photoepilation.
J Drugs Dermatol. 2016;15(5):615-625.
Treatment of Mild-to-Moderate Chronic Hand Dermatitis With Clobetasol Propionate 0.05% EF Foam: Results From an Open-Label Study
Leon H. Kircik MDa,b and Cathy Tropmann RPhc| |
Objective: To assess the safety and efficacy of clobetasol propionate 0.05% emulsion formulation (EF) foam in subjects with mild-to-moderate chronic hand dermatitis.
Methods: This was a single-center, open-label pilot study of 30 adults with chronic hand dermatitis. Subjects were treated with clobetasol propionate 0.05% EF foam twice-daily and returned for assessment at day 8 and day 15. The primary efficacy endpoint was the proportion of subjects who achieved treatment success, defined as improvement of ≥1 grade in their chronic hand dermatitis as per the Investigator's Static Global Assessment (ISGA) from baseline to day 15. Safety and quality-of-life measures were also assessed.
Results: A minimum 1-grade improvement in the ISGA was achieved by 96.7 percent (29/30) of subjects at day 15, with 80 percent (24/30) of subjects achieving a score of 0 (clear) or 1 (almost clear). Clobetasol propionate 0.05% EF foam appeared to be safe and well-tolerated, with only four subjects experiencing treatment-related adverse events. No pattern of adverse event occurrence or predisposition could be delineated from this study.
Conclusion: Clobetasol propionate 0.05% EF foam appeared to be safe and effective for the treatment of chronic hand dermatitis.
J Drugs Dermatol. 2011;10(12):1398-1402.
Cindy Wassef BA,a Adriana Lombardi MD,b Sairah Khokher MD,c and Babar K. Rao MDc| |
OBJECTIVE: The objective of this review was to describe the various surgical, laser, and alternative therapies available for vitiligo. A literature review was conducted through Pubmed and Ovid using the search terms "Vitiligo treatment”, “Vitiligo surgery”, “Vitiligo laser”. Since no articles were available about needling on both Pubmed and Ovid using the search criteria, individual articles were sought out through Google.
RESULTS: The literature review yielded many possible surgical interventions including autologous mini-punch grafting, suction epidermal blister grafting, split-thickness grafting, and cultured and noncultured melanocyte keratinocyte transfer. Laser options included the helium-neon and xenon-chloride lasers, with tattooing and needling serving as other options. While all the above techniques can provide improvement to pigmentation in vitiliginous patches, physician comfort and experience are important factors with regards to outcome. Our case series of four patients treated with the needling method yielded favorable results, with repigmentation rates ranging from 25-50%, with one patient having 90% repigmentation.
CONCLUSION: There are many surgical, laser, and alternative treatment options available for vitiligo when conventional medical therapy fails or for use in conjunction with medical therapies. Autologous mini punch grafting and needling both have minimal equipment requirements and are easy to learn. Physician experience and comfort play a large role in outcome and availability of services.
J Drugs Dermatol. 2013;12(6):685-691.
Adam Friedman MDa and Adnan Nasir MDb| |
Background: Nanotechnology is a rapidly growing discipline with important implications for consumers, patients, physicians and investigators.
In an era when nanotechnology is being both incorporated into educational requirements for medical fields such as radiology and oncology and vigorously pursued and developed by cosmeceutical companies, dermatology is falling behind. A survey was conducted to ascertain knowledge, attitudes and perception of nanotechnology in dermatology teaching programs.
Methods: To ascertain baseline knowledge, attitudes and preceptions regarding nanotechnology among dermatology trainees, dermatology investigators and dermatology faculty in US academic medical centers, an online survey was sent out to random members of the dermatology community and data analyzed (100 participants, 23% response rate). Participants responded to a questionnaire on a five-point scale ranging from strongly disagree, disagree, uncertain, agree, to strongly agree. Due to the low response rate, strongly disagree/disagree and strongly agree/agree values were combined and compared to uncertain responses.
Results: Approximately equal numbers of faculty vs. chief residents responded to the survery (52% vs. 47.75%, respectively). The majority of respondents had not previously attended any educational activity on nanotechnology (69.57%). The majority of participants agreed that more education on nanotechnology for dermatologists is needed (78.26% agreed vs. 21.74% uncertain) and that it should be incorporated into the residency training curriculum (60.87% agree vs. 13.04% disagree). Participants mostly agreed that nanotechnology research can contribute to better fundamental understanding of skin disease (78.26%), to advances in the diagnosis of skin disease (73.91%) and to therapies (78.26%). Participants mostly agreed that more research is needed (82.60%) and that this research should be funded (78.26%). Not surprisingly, respondents were uncertain with respect to issues of nanotechnology safety both in the pharmaceutical realm (60.87%) and cosmeceutical realm (69.57%). Furthermore, the overwhelming majority responded that research is also needed to evaluate nanomaterial safety (86.96%).
Limitations: Both the populations size and response rate were low, possibly affecting the power and significance of the results in this study.
Conclusion: The survey results indicate a significant gap in dermatology training. Participants indicated a need for more training and education in the area of nanotechnology, and called for more research to evaluate the potential pitfalls associated with nanomaterials as well and to seek new advances in diagnostic and therapeutic modalities.
J Drugs Dermatol. 2011;10(9):1037-1041.
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.
Shivani S. Patel BS,a Karen E. Huang MS,a Alan B. Fleischer Jr. MD,a and Steven R. Feldman MD PhDa,b,c| |
METHODS: We conducted a query of ClinicalTrials.gov for dermatologic clinical trials from 2009 to 2013 for 6 common skin conditions: acne, psoriasis, rosacea, eczema and atopic dermatitis, actinic keratosis, and skin cancer. Results were sorted by condition and number of study subjects. This study did not involve any participants apart from the researchers.
RESULTS: Although there is an increasing trend in the number of trials performed annually, the results were not significant (P=.08). The average number of patients per study has not significantly changed (P=.12), but there was a significant increase in the number of large studies (201+ subjects) conducted over time (P=.002). Although there was significant variation based on dermatologic condition studied (global statistic P=.01), only skin cancer demonstrated a significant change in the number of studies registered annually (β=10.6 studies/year, P=.04).
CONCLUSIONS AND RELEVANCE: The sky does not appear to be falling, at least not yet, with regard to continued development of treatments for patients with skin disease.
J Drugs Dermatol. 2015;14(5):497-500.
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.
Emily P. Tierney MD,a David J. Kouba MD PhD,b C. William Hanke MD MPHc| |
Objective: To review the literature on the safety of tumescent liposuction, liposuction under general anesthesia and laser-assisted liposuction.
Results: Aggregate safety data on liposuction under tumescent anesthesia reveals over 100,000 body areas treated with liposuction. There were no serious complications of death, emboli, hypovolemic shock, perforation of thorax or peritoneum, thrombophlebitis, seizures, or toxic reactions to drugs. In contrast, in the plastic surgery literature, liposuction under general anesthesia was associated with complications of deep venous thrombosis or pulmonary embolus, abdominal or other organ perforation, infection, and bleeding. Most recently, survey data in the European literature analyzed data showed 72 cases of severe complications from liposuction, including 23 deaths in a 5-year period from 1998 to 2002. The most frequent complications were bacterial infections such as necrotizing fasciitis, gas gangrene, and different forms of sepsis. Further causes of lethal outcome were hemorrhages, perforation of abdominal viscera, and pulmonary embolism.
Conclusion: Tumescent local anesthesia utilizing lidocaine with epinephrine allows the removal of large volumes of fat with minimal associated blood loss and postoperative morbidity.
J Drugs Dermatol. 2011;10(12):1363-1369.
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.
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.
Biophysical Evaluation of Fractional Laser Skin Resurfacing With an Er:YSGG Laser Device in Japanese Skin
Background: Ablative fractional laser skin resurfacing (FLSR) has recently been used for the amelioration of acne scars, and previous
studies have shown clinical effectiveness. Despite its extensive use, few studies have focused on the associated changes in biophysical
properties of the epidermis. Herein, we evaluate transepidermal water loss, sebum levels, skin hydration, and skin elasticity, following
FLSR treatments with an Er:YSGG laser device (Pearl FractionalTM , Cutera Inc., Brisbane, CA), employing non-invasive measurements.
Methods: Five Japanese patients with facial acne scars underwent one FLSR session. Some acne scars appeared to become less obvious as a consequence of the treatment. All patients were aware of a feeling of skin tightness in treated areas.
Results: Objective measurements on the lower lateral angle of the eye and on the inner cheeks were evaluated at baseline and at 3 days, 1 week, and 4 weeks after FLSR. Transepidermal water loss showed a significant two-fold (100%) increase at day 3, but had returned to almost the baseline level at week 4 in both areas. Sebum secretion showed a 50% increase at day 3, but had returned to the baseline level after day 7. Skin hydration showed a significant decrease at day 3, but had returned to the baseline level by day 7, and showed significant improvement at the end of the study. Skin elasticity (R2) was still at baseline on day 3, but showed some improvement—an increase of at least 30%—at the end of the study.
Conclusions: Based on our findings, we believe that FLSR should be performed no more than once a month to allow sufficient time for the damaged skin to recover its barrier function in most areas of the face.
J Drugs Dermatol. 2012;11(5):637-642.
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.
E. Victor Ross MDa and James Childs PhDb| |
STUDY DESIGN/MATERIALS AND METHODS: Porcine skin and fat tissue were prepared and separated to form a 2mm skin layer above a 1 cm thick fat layer. A 50μm thermocouple was placed between the layers and centered beneath a 23 x 38 mm treatment window of an 805 nm diode laser device (Vectus, Cynosure, Westford, MA). Apertures provided various incident beam spot sizes and the temperature rise of the thermocouple was measured for a fixed fluence.
RESULTS: The 2mm deep target's temperature rise versus treatment area showed two regimes with different positive slopes. The first regime up to approximately 1 cm2 area has a greater temperature rise versus area than that for the regime greater than 1 cm2. The slope in the second regime is nonetheless appreciable and provides a fluence reduction factor for skin safety. The same temperature rise in a target at 2 mm depth (typical hair bulb depth in some areas) is realized by increasing the area from 1 to 4 cm2 while reducing the fluence by half.
CONCLUSIONS: The role of spot size and in situ beam divergence is an important consideration to determine optimum fluence settings that increase skin safety when treating deeper targets.
J Drugs Dermatol. 2015;14(12):1437-1442.
Michael T. Jarratt MD,a Terry M. Jones MD,b Joan-En Chang-Lin PhD,c Warren Tong PharmD MS,c David R. Berk MD,c Vince Lin PhD,c and Alexandre Kaoukhov MDc| |
J Drugs Dermatol. 2016;15(10):1250-1259.
Evaluation of the Efficacy, Tolerability, and Safety of an Over-the-Counter Acne Regimen Containing Benzoyl Peroxide and Salicylic Acid in Subjects With Acne
Leon H. Kircik MD,a-c Lawrence J. Green MD,d Joseph Eastern MD,e Victoria Butners BSc,f and Jennifer Gwazdauskas MBAf| |
J Drugs Dermatol. 2013;12(3):259-264.
Joel Schlessinger MD,a Subhash Saxena PhD,b and Stuart Mohrb| |
J Drugs Dermatol. 2016;15(4):496-503.
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.
The Efficacy and Safety of Efinaconazole 10% Solution for Treatment of Mild to Moderate Onychomycosis: A Pooled Analysis of Two Phase 3 Randomized Trials
Aditya K. Gupta MD PhD FRCPC,a,b Boni E. Elewski MD,c Jeffrey L. Sugarman MD PhD,d
Chikara Ieda,e Hideki Kawabata MS,e Robert Kang PhD,f Radhakrishnan Pillai PhD,g
Jason T. Olin PhD,f and Shinichi Watanabe MD PhDh
OBJECTIVES: To investigate the efficacy and safety of efinaconazole 10% solution in pooled Phase III clinical trial participants with mild to moderate onychomycosis.
METHODS: Phase III clinical trials data from NCT01008033 and NCT01007708 were pooled. Efficacy analysis for the primary and secondary outcome variables was conducted using the mITT population and analysed using Cochran-Mantel-Haenszel tests. Subgroup analysis was conducted for prognostic factors that may affect drug efficacy. Safety analysis was conducted on all recipients of a single drug dose.
RESULTS: Efinaconazole 10% nail solution was superior to vehicle for all primary and secondary outcome measures assessed. Complete cure was 18.5% vs 4.7% P<0.001 [mITT] and mycological cure was 56.3% vs 16.6%, P<0.001 [mITT]. Complete or almost complete cure and treatment success were achieved in 27.7% and 47.2% compared to 7.9% and 18.2% with vehicle, respectively (P<0.001 [mITT]). In all subgroups, efinaconazole 10% solution had statistically higher cures rates compared to vehicle. Higher complete cure rates were observed in women and individuals with mild disease (≤33% involvement), but not in any other subgroup assessed. Treatment associated adverse events in the efinaconazole 10% solution group were similar to vehicle and limited to local site reactions (2%).
CONCLUSIONS: The findings from this pooled analysis suggest that efinaconazole 10% solution may become the preferred topical agent for mild to moderate onychomycosis.
J Drugs Dermatol. 2014;13(7):815-820.
David A. Sanchez BS,a,e Joshua D. Nosanchuk MD,b,c and Adam J. Friedman MDa,d,| |
J Drugs Dermatol. 2015;14(2):127-130.
J Drugs Dermatol. 2012;11(9):1089-1093.
J Drugs Dermatol. 2012;11(7):804-807.
Tatjana Pavicic MD| |
J Drugs Dermatol. 2013;12(9):996-1002.
Han-deng Tu MD,a,b,c Yuan-hong Li MD PhD,b Hong-fu Xie MD,a Jia-mei Xiong MD,c Bing Wang MD,b Xue-gang Xu MD,b La-ga Tong MD,b LiLi MD,b Michael H. Gold MD,d and Hong-Duo Chen MDb| |
OBJECTIVE: The objective was to evaluate the efficacy and safety of a dual-wavelength laser device in treatment of neck and facial PWS in a direct side-by-side comparison.
METHODS: Sixteen Chinese patients with neck and/or facial PWSs were enrolled in the study. All lesions were randomly divided into two area, treated area and adjacent untreated area. Five successive treatments using a dual-wavelength laser system (595-nm PDL combined with 1,064-nm Nd:YAG laser) were delivered on treated areas at 4- to 6-week intervals. The adjacent area was not treated as self control. Two blinded dermatologists evaluated the clinical changes by comparing the before and after photos. Erythema index (EI) values were measured with a non-invasive instrument.
RESULTS: After five sessions of treatment, over 62.5% (10/16) patients achieved more than 50% (moderate or significant) improvement. The efficacy maintained at the 3-month follow-up visit. The values of EI on treated area showed a significant decrease. Adverse effects of treated area were limited.
CONCLUSION: Using this split-face module, the dual-wavelength laser system is proved to be effective and well tolerated in treating neck and facial PWSs in Chinese patients. Adverse effects were minimal and acceptable.
J Drugs Dermatol. 2015;14(11):1336-1340.
Sewon Kang MD,a Vicente Torres Lozada MD,b Vincenzo Bettoli MD,c Jerry Tan MD,d Maria Jose Rueda MD,e Alison Layton MB ChB,f Lauren Petit BS,g and Brigitte Dréno MD PhDh| |
OBJECTIVES: Evaluate classification for atrophic acne scars by shape, size, and facial location and establish reliability in assessments.
METHODS: We conducted a non-interventional study with dermatologists performing live clinical assessments of atrophic acne scars. To objectively compare identification of lesions, individual lesions were marked on a high-resolution photo of the patient that was displayed on a computer during the clinical evaluation. The Jacob clinical classification system was used to define three primary shapes of scars 1) icepick, 2) boxcar, and 3) rolling. To determine agreement for classification by size, independent technicians assessed the investigators’ markings on digital images. Identical localization of scars was denoted if the maximal distance between their centers was ≤ 60 pixels (approximately 3 mm). Raters assessed scars on the same patients twice (morning/afternoon). Aggregate models of rater assessments were created and analyzed for agreement.
RESULTS: Raters counted a mean scar count per subject ranging from 15.75 to 40.25 scars. Approximately 50% of scars were identified by all raters and ~75% of scars were identified by at least 2 of 3 raters (weak agreement, Kappa pairwise agreement 0.30). Agreement between consecutive counts was moderate, with Kappa index ranging from 0.26 to 0.47 (after exclusion of one outlier investigator who had significantly higher counts than all others). Shape classifications of icepick, boxcar, and rolling differed significantly between raters and even for same raters at consecutive sessions (P<.001 and P=0.4, respectively). Analysis showed only 65% of scars were identical in both sessions. We also found that there is a threshold of detection in terms of size, with poor agreement among investigators for very small scars (<2 mm). The repeatability of identification of scars ≥ 2.0 mm was acceptable, and we found that increasing scar size was positively correlated with agreement. Reliability was improved when only scars >2 mm were included. For smaller scars (<2 mm), inter-rater reliability was poor.
CONCLUSIONS: While intuitively it makes sense that describing scar morphology could guide treatment, we have shown that shape-based evaluations are subjective and do not readily yield strong agreement. Until there is a more objective way to evaluate morphology that is readily available to practicing clinicians, we propose that size should be considered a primary characteristic for scar classification systems. We further suggest classification of <2 mm, 2-4 mm, and >4 mm based on how the size would likely affect diagnostic and therapeutic choices. Finally, we recommend that scars <2 mm not be included in a clinical classification but should be evaluated by an objective method that may be refined in the future.
J Drugs Dermatol. 2016;15(6):693-702.
Results of a Phase 2, Randomized,Vehicle-Controlled Study Evaluating the Efficacy,Tolerability, and Safety of Daily or Twice Daily SB204 for the Treatment of Acne Vulgaris
Lawrence F. Eichenfield MD,a Linda Stein Gold MD,b Walter K. Nahm MD PhD,c Fran E. Cook-Bolden MD,d and David M. Pariser MDe| |
Ethan T. Routt MD,a Shelbi C. Jim On MD,a Joshua A. Zeichner MD,a and Leon H. Kircik MDb,c,d| |
J Drugs Dermatol. 2014;13(4):391-395.
Derek Ho BSa and Jared Jagdeo MD MSa,b,c| |
OBJECTIVE: We sought to systematically review clinical studies and expert opinions of this 20 mg/ml HA dermal filler and to provide evidence-based recommendations and expert opinions.
METHODS AND MATERIALS: A search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch, Pascal, HCAPlus, IPA, and Dissertation Abstracts was performed on August 18th 2014.
RESULTS: Thirteen articles met inclusion and were included in our review: clinical trials with this 20 mg/ml HA dermal filler (10) and expert opinions and questionnaire survey studies of experts (3). This 20 mg/ml HA dermal filler has shown consistent, favorable results for treatment of age-related facial volume loss, aesthetic enhancement, and HIV facial lipoatrophy.
CONCLUSION: HA fillers are safe and effective with minimal recovery time and complications. Future studies with longer follow-up period and use of this 20 mg/ml HA dermal filler on areas other than midface may provide additional efficacy and safety outcomes.
J Drugs Dermatol. 2015;14(9):934-940.
Erin Gilbert MD PhDa and Lucia Calvisi MDb| |
OBJECTIVE: To analyse and discuss the approach to midface as well as lip and perioral volume restoration by two independent dermatologists working in the US and Italy.
METHODS: Seven patients were selected for discussion and divided into two groups: 1) those requiring midface volumization and 2) those undergoing perioral or lip volume replacement. Patients in the midface group were injected with Juvéderm Voluma® XC, Juvéderm® Volift® with lidocaine, Restylane- L®, Perlane-L® or Radiesse®. Patients in the perioral and/or lip group were injected with Juvéderm® Volbella™, with lidocaine, or Belotero Balance™. Patients were photographed before and immediately after injection to evaluate aesthetic outcomes. In each case, filler selection was based upon patient characteristics, anatomical considerations and inherent filler properties.
Results: All patients were extremely satisfied with their treatments. There were no significant immediate or delayed complications following treatment with any of the dermal fillers used.
CONCLUSIONS: Volume restoration in the midface and perioral or lip region can be effectively achieved using a variety of dermal fillers. The dermal filler portfolio available in Europe is exponentially larger than that in the US. Product selection in either market is ultimately the result of the physician’s experience injecting each dermal filler, as well as his or her personal preferences.
J Drugs Dermatol. 2014;13(1):67-74.
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.
Evan A. Rieder MD,a Euphemia W. Mu MD,a and Jeremy A. Brauer MDa,b,c| |
J Drugs Dermatol. 2015;14(9):1023-1026.
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.
A Randomized, Prospective, Sham-Controlled Study of Localized Narrow-Band UVB Phototherapy in the Treatment of Plaque Psoriasis
Adriane A. Levin BA,a,b Saud Aleissa MD,a Nicole Dumont,a Francisca Martinez,a Courtney Donovan RN,a
Shiu-chung Au MD,a Afnan Hasanain MD,a and Alice B. Gottlieb MD PhDa,c
OBJECTIVE: We aimed to evaluate the efficacy of the Levia® localized NB-UVB phototherapy machine in the treatment of patients with symmetrical psoriatic lesions.
DESIGN: We performed a prospective, double-blinded, sham-treatment controlled study of this device beginning March 2012 through April 2014.
SETTING: a comprehensive dermatology clinic in the northeastern United States.
PARTICIPANTS: 21 subjects with chronic plaque psoriasis.
INTERVENTIONS: Each patient had one lesion randomized to receive the Levia treatment and one lesion (the control) treated with visible light. Treatment was administered three times a week for twelve weeks. Target lesion score (TLS), a rating of 0-4 each of erythema, scaling, and thickness, was measured biweekly by a blinded assessor, and visual analogue scale of pruritus was recorded by subjects.
MAIN OUTCOMES AND MEASURES: The primary outcome, formulated prior to study initiation, was the percentage of lesions achieving clear or almost clear TLS after 12 weeks of treatment. Secondary endpoints included changes in target lesion pruritus VAS, percentage improvement in TLS, and the percentage of subjects achieving 50% improvement in TLS (TLS-50).
RESULTS: The primary endpoint, TLS of three or less, was not achieved (P=0.118), but the secondary endpoints of percentage improvement in TLS (P=0.043) and TLS-50 (P=0.0195) were significantly superior in treated compared to sham-treated lesions. Percentage improvement in pruritus VAS was not significant (P=0.0565).
CONCLUSIONS AND RELEVANCE: This device was found to be efficacious, though not necessarily to the point of clearance, in the treatment of psoriasis over a 12-week period.
TRIAL REGISTRATION: www.clinicaltrials.gov, identifier: NCT02107482, http://clinicaltrials.gov/show/NCT02107482
J Drugs Dermatol. 2014;13(8):922-926.
Trends in the Treatment of Acne Vulgaris: Are Measures Being Taken to Avoid Antimicrobial Resistance?
Megan A. Kinney MHAM BS,a Brad A. Yentzer MD,a Alan B. Fleischer Jr. MD,a Steven R. Feldman MD PhDa,b,c| |
Purpose: The aim of this study was to assess trends in prescribing antibiotics for acne from 1997−2006.
Methods: The authors examined the National Ambulatory Medical Care Survey (NAMCS) database and recorded medications at all visits to the physician in which acne vulgaris (ICD-9-CM code 706.1) was the only diagnosis from 1997−2006.
Results: Declines in the use of erythromycin and isotretinoin (both P<0.001) for acne were noted for all physicians. Tetracyclines saw significant increases in use by both dermatologists and non-dermatologists (P<0.01 and P=0.05, respectively). Prescribing of benzoyl peroxide monotherapy was unchanged for non-dermatologists (P=0.22) and is on the decline for dermatologists (P<0.001). The use of BPO + clindamycin combination topical treatments rose sharply for all physicians (P<0.001), resulting in greater use of both total BPO and total clindamycin for acne over time (P<0.001). Topical retinoid use increased among dermatologists (P<0.05) but appeared to be on the decline among non-dermatologists (P=0.067).
Conclusion: The development of antibiotic resistance is of concern. Greater awareness of retinoid use for maintenance therapy, using topical benzoyl peroxide to prevent resistance, and limiting use of oral antibiotics to as short a time period as possible are measures to contribute to better eco-responsible acne treatment.
Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: First of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-controlled Trials
Linda F. Stein Gold MD,a Michael T. Jarratt MD,b Alicia D. Bucko DO,c Steven K. Grekin DO,d
Joshua M. Berlin MD,e Michael Bukhalo MD,f Jonathan S. Weiss MD,g David R. Berk MD,h
Joan–En Chang–Lin PhD,h Vince Lin PhD,h and Alexandre Kaoukhov MDh
OBJECTIVE: The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (P<.001) had GAAS success. Mean inflammatory lesions decreased by 55.5% and 49.0%, noninflammatory lesions decreased by 44.4% and 38.4%, and total lesions decreased by 48.7% and 42.4% in the dapsone gel, 7.5% and vehicle groups (all P<.001), respectively, at week 12. The incidence of adverse events was similar in the dapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of “none” for stinging/burning, dryness, scaling, and erythema scales at all time points.
CONCLUSIONS: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne.
J Drugs Dermatol. 2016;15(5):553-561.
Pilot Randomized-Control Trial to Assess the Effect Product Sampling has on Adherence Using Adapalene/Benzoyl Peroxide Gel in Acne Patients
Laura F. Sandoval DO,a Ashley Semble MS,a Cheryl J. Gustafson MD,a Karen E. Huang MS,a Michelle M. Levender MD,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: To determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence.
METHODS: Subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks. Subjects were randomized into sample or no sample group. Sample group received a demonstration on how to apply the medication using a product sample. The primary outcome was median adherence, recorded using electronic monitoring, and secondary outcomes were efficacy measures including the Acne Global Assessment (AGA) and lesion counts and the Perceived Medical Condition Self-Management Scale (PMCSMS).
RESULTS: Data from 17 patients was collected and analyzed. Median adherence rates were 50% in the sample group and 35% in the no sample group (p=0.67). The median percent improvement in non-inflammatory lesions were 46% for the sample group and 33% for the no-sample group (p=0.10).
LIMITATIONS: The small size of this pilot study limited the extent of subgroup analyses.
CONCLUSIONS: Objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne. There is a considerable potential effect size on adherence for the use of samples, supporting the need for future, well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases.
J Drugs Dermatol. 2014;13(2):135-140.
Olha Ilnytska PhD, Simarna Kaur PhD, Suhyoun Chon PhD, Kurt A. Reynertson PhD, Judith Nebus MBA,
Michelle Garay MS, Khalid Mahmood PhD, and Michael D. Southall PhD
J Drugs Dermatol. 2016;15(6):684-690.
Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: Second of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-Controlled Trials
Lawrence F. Eichenfield MD,a Ted Lain MD,b Ellen H. Frankel MD,c Terry M. Jones MD,d Joan-En Chang-Lin PhD,e David R. Berk MD,e Shiling Ruan PhD,e and Alexandre Kaoukhov MDe| |
OBJECTIVE: The study objective was to assess the efficacy and safety, compared with vehicle, of acne treatment with a recently FDA-approved, once-daily formulation of dapsone gel, 7.5%, with a 50% greater concentration of dapsone.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients aged 12 years and older with 20–50 facial inflammatory lesions, 30–100 facial noninflammatory lesions, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized (1:1 ratio) to topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with a GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2238 patients (1118 in the dapsone gel, 7.5% group and 1120 in the vehicle group). The GAAS success rates were 29.8% for the dapsone gel, 7.5% group and 20.9% for the vehicle group (P<0.001) at week 12. At week 12, mean inflammatory lesions decreased from baseline by 53.8% and 47.3%, noninflammatory lesions decreased by 45.9% and 40.4%, and total lesions decreased by 48.9% and 43.2% for the dapsone gel, 7.5% group and the vehicle group, respectively (all, P<0.001). The incidence of treatment-emergent adverse events was similar for dapsone gel, 7.5% (17.6%) and vehicle (17.1%). Most adverse events were mild to moderate in severity. The most frequently reported increase in severity for all of the dermal tolerability scales was from “none” to “mild.”
CONCLUSION: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne vulgaris. Improvements in acne severity and lesions were observed over the 12-week course of treatment.
J Drugs Dermatol. 2016;15(8):962-969.
A Substitute for Skin Grafts, Flaps, or Internal Tissue Expanders in Scalp Defects Following Tumor Ablative Surgery
Moris Topaz MD,a,b Narin-Nard Carmel BSc,c Guy Topaz BSc,c Isaac Zilinsky MDd| |
OBJECTIVES: To evaluate the efficacy of the TopClosure® system in primary closure of moderate and large scalp defects, as a substitute for skin grafts, flaps, and tissue expanders.
METHODS: We report a retrospective series of 8 patients requiring resection of 9 scalp tumors resulting with moderate to large size defects that otherwise would have required reconstruction with skin grafts, flaps, or tissue expanders. TopClosure® was applied for intraoperative cycles of stress-relaxation, followed, when indicated, by additional steps of mechanical creep and scar secure.
RESULTS: Skin defects, averaging 3.5 cm, were managed by TopClosure®, enabling, primary closure in all wounds. Immediate wound edge approximation was reached through stress-relaxation in 2 wounds by heavy tension sutures within one hour. Further skin stretching by mechanical creep was required in 7 wounds, achieving staged primary closure in an outpatient setting. TopClosure® was further applied to secure the skin for up to 3 weeks following surgery.
CONCLUSIONS: The TopClosure system, effectively, aided closure of moderate and large scalp defects by stress-relaxation and mechanical creep and serving as a topical tension-relief platform for tension sutures, allowing mobilization of skin and subcutaneous tissue without undermining or need of drainage, for early, direct wound closure. Local complications were minimal and donor site morbidity was eliminated. Surgical time, hospital stay and costs were reduced, and post-operative wound aesthetics were improved.
J Drugs Dermatol. 2014;13(1):48-55.
Evaluation of Moisturizing Effect of Methanolic Extract of Five Medicinal Plants Incorporated Into Cream Bases Using Impedance and Extensiometry Methods
Background: Skin moisturizing is an important issue due to its impact on skin function. Adverse reactions to herbal extracts have been rarely reported and can be used in moisturizers. This study was conduct to evaluate moisturizing effect of a methanolic extract of five medicinal plants incorporated into cream bases.
Methods: Methanolic extract of five medicinal plants including olive, burdock, licorice, mallow and marsh horsetail was prepared. The extracts were dissolved in distilled water completely and freeze-dried to a dry powder. These extracts were added separately to the cream based formulation that has been suggested to be appropriate for adding herbal extracts. Moisturizing effects of these creams with herbal extracts were assessed using the impedance method on 12 rats equally divided into six groups (one control and five cases), as well as the extensiometry method on 25 mice divided into five groups (in each group one cream with herbal extract and control cream were tested concurrently). Obtained results were compared with the control cream based.
Results: The maximum moisturizing effect was observed with the marsh horsetail. Other creams with herbal extracts, except the one with the licorice, also exerted significantly higher moisturizing effect compared to the controls (P<0.05). Regarding the force for skin tearing, the differences were statistically significant in all groups when compared to the control group (P<0.05) and the highest difference was seen in the marsh horsetail group (2.0832 ± 0.6811 kgN).
Conclusions: The highest moisturizing activity was observed using marsh horsetail extract that can be explained by flavonoids content of marsh horsetail.
J Drugs Dermatol. 2011;10(10):1116-1121.
Ralph Fiore II DO, Sarah M. Coffman DO MSc, and Richard Miller DO| |
J Drugs Dermatol. 2013;12(3):353-357.
Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design
William C. Ports DVM,a Steven R. Feldman MD PhD,b Pankaj Gupta PhD,a Huaming Tan PhD,a Theodore R. Johnson PhD,c and Robert Bissonnette MDd| |
J Drugs Dermatol. 2015;14(8):777-784.
James R. Schwartz PhD| |
J Drugs Dermatol. 2016;15(2):140-144.
Christine Rønneberg Mehren MD,a Anders Clemmensen MD,a Anne Boe-Hansen Dall MD,a
Peter Philipsen PhD,a and Robert Gniadecki MDa,b
AIM: To assess the relative contribution of the different symptom domains on HRQoL in psoriasis.
METHODS: 165 psoriasis patients (41.2 % with psoriasis arthritis (PsA)) were enrolled in a single-center cohort-study. For the assessment of HRQoL, patients completed EuroQoL (EQ-5D), the Short Form 36-item Health Survey (SF-36), the Health Assessment Questionaire (HAQ), and Dermatological Life Quality Index (DLQI) questionnaires. Multiple regression analysis was applied to determine the contribution of the measured parameters to the EuroQoL score (used as a reference measure for overall HRQoL).
RESULTS: Psoriasis arthritis (PsA) patients showed a higher impairment in all HRQoL measures than the patients without PsA. PASI, number of affected joints (PsA-score), DLQI and HAQ were significant predictors of HRQoL (R2=0.57). HAQ was the dominant contributor to HRQoL, both in patients with PsA and without PsA (partial eta 0.23 and 0.28, respectively.) Final model with improved R2 (0.61) was obtained by backward regression analysis, and included 6 parameters: PASI, PsA-score, and three questions from HAQ and one question from DLQI questionnaire.
CONCLUSION: Musculoskeletal symptoms are an essential component of HRQoL in psoriasis, even in patients without active PsA. A model consisting of PASI, PsA-score, and 4 questions derived from DLQI and HAQ seems to reflect total HRQoL impairment in psoriasis. This finding may further optimize drug therapy in psoriasis.
J Drugs Dermatol. 2014;13(3):246-250.
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.
Fractional Ablative Laser Followed by Transdermal Acoustic Pressure Wave Device to Enhance the Drug Delivery of Aminolevulinic Acid: In Vivo Fluorescence Microscopy Study
Jill S. Waibel MD,a Ashley Rudnick,a Carlos Nousari MD,b and Dhaval G. Bhanusali MDc| |
METHODS: Five patients were treated and biopsied at 4 treatment sites: 1) topically applied aminolevulinic acid (ALA) alone; 2) fractional ablative CO2 laser and topical ALA alone; 3) fractional ablative CO2 laser and transdermal acoustic pressure wave device delivery system; and 4) topical ALA with transdermal delivery system. The comparison of the difference in the magnitude of diffusion with both lateral spread of ALA and depth diffusion of ALA was measured by fluorescence microscopy.
RESULTS: For fractional ablative CO2 laser, ALA, and transdermal acoustic pressure wave device, the protoporphyrin IX lateral fluorescence was 0.024 mm on average vs 0.0084 mm for fractional ablative CO2 laser and ALA alone. The diffusion for the acoustic pressure wave device was an order of magnitude greater.
CONCLUSION: We found that our combined approach of fractional ablative CO2 laser paired with the transdermal acoustic pressure wave device increased the depth of penetration of ALA.
J Drugs Dermatol. 2016;15(1):14-21.
Detection and Relevance of Naftifine Hydrochloride in the Stratum Corneum Up to Four Weeks Following the Last Application of Naftifine Cream and Gel, 2%
Stefan Plaum MD, Amit Verma DrPH MPH, Alan B. Fleischer Jr. MD,
Babajide Olayinka MSc, and Bhushan Hardas MD
OBJECTIVE: The objective is to use tape stripping methodology to assess the amount of drug available in the SC over a 28 day period following the last dose.
METHODS: This was an open-label, single-exposure study on subjects comparing the amount of drug that was absorbed into the SC following topical application for 2-weeks. Twelve subjects were dosed daily (6 with naftifine cream, 2% and 6 with naftifine gel, 2%). Subjects had twelve 8 cm2 test application sites demarcated on the upper back. Twenty-five individual sequential strips were obtained from each test site. Of these, 11 sites were dosed once daily with the drug (5.0μL/cm2) for days 1 to 14 and the final site served as the control. On days 15, 29, and 43, a site was stripped to collect the SC in order to process the amount of drug present.
RESULTS: Naftifine was present on all tape strip samples collected over the 28 day period following two weeks of application. Furthermore, the most relevant, deeper tape strip sets reflecting the SC, showed potentially clinically relevant presence of naftifine in the skin for 28-days post-treatment.
CONCLUSIONS: Naftifine was present in the tape strips on all sample collection days up to and including four weeks following the last drug application. These findings help explain the progressive improvement in clinical and mycological response rates during the treatment period and for up to four weeks post-treatment in the clinical trials using naftifine.
J Drugs Dermatol. 2013;12(9):1004-1008.
Differentiation of Basal Cell Carcinoma Subtypes in Multi-Beam Swept Source Optical Coherence Tomography (MSS-OCT)
Adam Meekings BSc,a Sarah Utz BA,d Martina Ulrich MD,f Amanda Bienenfeld BA,d,e Naveen Nandanan MD,e Juliya Fisher MD,c Gordon McKenzie PhD,b Daniel M. Siegel MD FAAD,c Eleanor Feldman BA,c and Orit Markowitz MD FAADc| |
OBJECTIVES: To identify and describe key features of basal cell carcinoma (BCC) and its subtypes as they present in multi-beam Swept Source – OCT (MSS-OCT), and to correlate those against conventional histopathology.
METHODS: A total of 40 lesions were assessed by MSS-OCT prior to biopsy. 60-slice OCT images of the lesions were obtained and correlated with histology sections taken in the same plane. OCT scans were assessed retrospectively by a panel to determine the OCT criteria for BCC and its subtypes.
RESULTS: The following diagnostic criteria were identified: hyporeflective ovoid structures (40/40), dark halo boundaries (38/40), epidermal thinning (28/40), and collagen compression (14/40). Lesional tissue also showed a destruction of layers when compared to the surrounding normal tissue. In addition to the shared criteria, other subtypes showed distinct diagnostic criteria.
CONCLUSION: With its higher sensitivity, using MSS-OCT allowed for non-invasive, accurate identification of the key diagnostic features of BCC and its subtypes with high correlation to the histopathologic features found with biopsy.
J Drugs Dermatol. 2016;15(5):545-550.
Shino Bay Aguilera DO FAAD,a Sean Branch DO FAAD,b and Luis Soro DO FAADa| |
Dina Coronado BS, Tejal Merchant MPharm, Sanjay Chanda PhD, and Lee T. Zane MD| |
J Drugs Dermatol. 2015;14(6):609-614.
Evaluation of Efficacy and Tolerance of a Nighttime Topical Antioxidant Containing Resveratrol, Baicalin, and Vitamin E for Treatment of Mild to Moderately Photodamaged Skin
Patricia Farris MD,a Margarita Yatskayer MS,b Nannan Chen PhD,b Yevgeniy Krol BS,c Christian Oresajo PhDb| |
J Drugs Dermatol. 2014;13(12):1467-1472.
2016 Arte Poster Competition First Place Winner: Circadian Rhythm and UV-Induced Skin Damage: An In Vivo Study
Linna Guan BS,a,* Amanda Suggs MD,a,* Sayeeda Ahsanuddin BS,a Madeline Tarrillion DO,a Jacqueline Selph MD,a Minh Lam PhD,a and Elma Baron MDa,b,c| |
J Drugs Dermatol. 2016;15(9):1124-1130.
Clinical Evidence for the Role of a Topical Anti-Inflammatory Agent in Comedonal Acne: Findings From a Randomized Study of Dapsone Gel 5% in Combination With Tazarotene Cream 0.1% in Patients With Acne Vulgaris
Emil Tanghetti MD,a Sunil Dhawan MD,b Lawrence Green MD,c Mark Ling MD PhD,d Jeanine Downie MD,e Marguerite A. Germain MD,f J. Scott Kasteler MD,g Leon Kircik MD,h Michael G. Oefelein MD,i Zoe Draelos MDj| |
Background: Acne pathogenesis is multifactorial and includes inflammation. Combining drugs targeting multiple components of
acne pathogenesis is standard practice.
Objective: To assess the safety and efficacy of dapsone gel 5%, an anti-inflammatory agent, in combination with tazarotene cream 0.1% for treatment of acne vulgaris.
Methods: Patients were randomized to receive combination therapy (dapsone gel 5% twice-daily plus tazarotene cream 0.1% daily) or monotherapy (tazarotene cream 0.1% daily). Efficacy and safety data were collected after 1, 2, 4, 8, and 12 weeks of treatment.
Results: Patients in both arms (n=86, dapsone + tazarotene; n=85, tazarotene) showed significant reductions from baseline in inflammatory, noninflammatory and total lesion counts (P<.001 for all). At 12 weeks, patients treated with dapsone plus tazarotene showed a greater reduction from baseline in noninflammatory (comedonal) and total lesion counts than tazarotene-treated patients (noninflammatory, 59.7 percent vs. 46.5 percent, P=.01; total, 63.3% vs. 53.6%, P=.02). The percentage of patients achieving treatment success (an investigator subjective score of 0 [none] or 1 [minimal]) was greater in dapsone plus tazarotene-treated patients (42.2%) than in tazarotene-treated patients (21.8%;P=.01). Both treatments were well tolerated.
Conclusion: Combination therapy with dapsone gel 5% plus tazarotene cream 0.1% was more effective than tazarotene monotherapy for treatment of comedonal acne. The results suggest that anti-inflammatory agents such as dapsone can effectively treat early stages of acne (both comedonal and noncomedonal) when used in combination with a retinoid.
J Drugs Dermatol. 2011;10(7):783-792.
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.
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.
Customized Single-agent Therapy Management of Severe Inflammatory Acne: A Randomized, Double-blind, Parallel-group, Controlled Study of a New Treatment - Adapalene 0.3%-Benzoyl Peroxide 2.5% Gel
Jonathan Weiss MD,a Linda Stein Gold MD,b Matthew Leoni MD,c Maria Jose Rueda MD,d Hong Liu Msc,c and Emil Tanghetti MDe| |
OBJECTIVES: To demonstrate superior efficacy of adapalene 0.3%-benzoyl peroxide 2.5% gel (0.3% A/BPO) vs. vehicle, and to assess efficacy of 0.3% A/BPO vs. 0.1% A/BPO in subjects with severe inflammatory acne (Investigator’s Global Assessment [IGA] of 4) in the context of a larger trial in a moderate and severe population.
METHODS: This was a multicenter, randomized, double-blind, parallel-group, 12-week study. Subjects were randomized to receive 0.3% A/BPO, 0.1% A/BPO (benchmark) or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (percentage of subjects rated “clear” or “almost clear,” ≥3-grade IGA improvement), and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms.
RESULTS: In the severe inflammatory acne population, a total of 252 subjects were randomized with 106, 112 and 34 subjects in the 0.3% A/BPO, 0.1% A/BPO and vehicle groups, respectively, reaching a high rate of study completion (88.5%). At week 12, both 0.3% A/BPO and 0.1% A/BPO were superior to vehicle in terms of lesion count reduction. However for success rate, only 0.3% A/BPO achieved significantly greater efficacy over vehicle with a treatment difference of 20.1% (31.9% vs. 11.8%; 95% Confidence Interval (CI): [6.0%, 34.2%], P=.029), whereas 0.1% A/BPO did not (treatment difference vs. vehicle of 8.8%; P=.443). This translates to an 11% difference between active treatments in favor of 0.3% A/BPO. Also, 0.3% A/BPO was safe and well tolerated.
CONCLUSIONS: Availability of this new treatment option should allow clinicians to better customize severe inflammatory acne management, and the high-strength product provides a step-up treatment when needed.
J Drugs Dermatol. 2015;14(12):1427-1435.
Effects Of Benzoyl Peroxide 5% Clindamycin Combination Gel Versus Adapalene 0.1% on Quality of Life In Patients With Mild to Moderate Acne Vulgaris: A Randomized Single-blind Study
Background: Patients with acne vulgaris often have impaired quality of life (QOL). The fixed-dose combination of benzoyl peroxide 5%/clindamycin
1% gel (BPO/C) topical gel provides an earlier onset of action and is more effective against inflammatory and total facial lesions than adapalene
(AP) 0.1% gel.
Objective: To compare BPO/C and AP with regard to the early effect on QOL, efficacy, and tolerability in patients with mild to moderate acne vulgaris.
Methods: Patients were randomized to BPO/C or AP once nightly for 12 weeks in a multicentre, single-blind trial. The primary efficacy endpoint was QOL at week 2, assessed using the Skindex-29 questionnaire. Secondary endpoints included grading and counting of acne lesions; investigator assessments of peeling, erythema, and dryness, and patient-reported burning or itching. Adverse events were monitored during the study and during the 14-day minimum follow-up period.
Results: A total of 168 patients were enrolled, and 114 patients completed the study. In the intent-to-treat population, after 2 weeks of treatment, BPO/C was associated with a small but noticeably better improvement in global QOL compared with AP (-4.9 versus -1.1; P<0.001). A greater reduction in both total and inflammatory lesions was noted from week 1 onward (P<0.05) with BPO/C versus AP. At all time points, BPO/C was better tolerated than AP for all investigator-rated (dryness, peeling, erythema) and patient-rated (burning, itching) events (P<0.036).
Conclusions: BPO/C is associated with early improvements in QOL compared with AP. These QOL improvements are likely to be the result of better efficacy and tolerability outcomes observed with BPO/C.
J Drugs Dermatol. 2012;11(6):714-722
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.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.
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.
Secukinumab Improves Physical Function in Subjects With Plaque Psoriasis and Psoriatic Arthritis: Results from Two Randomized, Phase 3 Trials
Alice B. Gottlieb MD PhD,a Richard G. Langley MD,b Sandra Philipp MD PhD,c Bardur Sigurgeirsson MD PhD,d Andrew Blauvelt MD MBA,e Ruvie Martin PhD,f Charis Papavassilis MD PhD,g and Shephard Mpofu MDg| |
OBJECTIVE: To evaluate the efficacy of secukinumab in subjects with psoriasis and concomitant psoriatic arthritis (PsA) with respect to psoriasis symptoms and physical function, we conducted pre-specified subanalyses of the phase 3 FIXTURE and ERASURE trials.
METHODS: The 52-week FIXTURE and ERASURE trials randomized subjects with moderate-to-severe plaque psoriasis to subcutaneous secukinumab 300 or 150 mg (Baseline, weeks 1, 2, 3, every 4 weeks from week 4 until week 48), etanercept 50 mg (twice weekly through week 12, once weekly thereafter through week 51; FIXTURE only), or placebo. In this analysis, changes in Health Assessment Questionnaire–Disability Index (HAQ-DI) and PASI 75 responses were assessed in subpopulations with concomitant PsA (n=196, FIXTURE; n=171, ERASURE).
RESULTS: Physical functioning (mean change from Baseline in HAQ-DI) was greater with secukinumab 300 mg vs. placebo at week 12 in both trials (FIXTURE, -0.41 vs. 0.02/P=0.0001; ERASURE, -0.35 vs. -0.08/P=0.0003); corresponding values were -0.29 for etanercept and -0.19 for secukinumab 150 mg in FIXTURE and -0.18 for secukinumab 150 mg in ERASURE. Greater responses were seen in subjects with greater Baseline disability (HAQ-DI ≥05). Week 12 PASI 75 responses were higher with secukinumab 300 mg/150 mg vs. placebo in FIXTURE (72%/59% vs. 2%) and ERASURE (68%/70% vs. 4%; all P<0.0001) and with secukinumab 300 mg vs. etanercept (72% vs 39%; P=0.0084).
CONCLUSION: Secukinumab 300 mg produced significant improvement in psoriasis and physical functioning in subjects with concomitant PsA.
ClinicalTrials.gov numbers: NCT01358578 (FIXTURE); NCT01365455 (ERASURE)
J Drugs Dermatol. 2015;14(8):821-833.
Richard K. Scher MD,a Antonella Tosti MD,b Warren S. Joseph DPM,c Tracey C. Vlahovic DPM,d
Jesse Plasencia DPM,e Bryan C. Markinson DPM,f and David M. Pariser MDg
J Drugs Dermatol. 2015;14(9):1016-1021.
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.
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.
Porcia B. Love MDa and Roopal V. Kundu MDb| |
J Drugs Dermatol. 2013;12(4):403-409.
Tuyet A. Nguyen BA BS and Adam J. Friedman MD| |
J Drugs Dermatol. 2013;12(10):1131-1137.
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.
Terrence Keaney MD| |
J Drugs Dermatol. 2015;14(9):1036-1040.
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.
J Drugs Dermatol. 2012;11(10):1181-1192.
Ryan M. Trowbridgea and Mark R. Pittelkow MDb| |
J Drugs Dermatol. 2014;13(2):111-118.
Deborah S. Sarnoff MD FAAD FACPa,b and Robert H. Gotkin MD FACSb,c| |
OBJECTIVE: To demonstrate that a combination technique called ACELIFT – an acronym for the Augmentation of Collagen and Elastin using Lasers, Injectable neurotoxins, Fillers, and Topicals – in selected patients, is a viable, safe, and effective alternative to a facelift.
METHODS: Ten healthy women, ages 50 to 62 (mean age = 58), with cervical and facial stigmata of aging were enrolled in a prospective study conducted in the authors’ private practice. Patients underwent a two-step procedure; the first step was laser lipolysis of the submental and anterior cervical areas with a pulsed 1440nm Nd:YAG laser with a side-firing fiber (PrecisionTx, Cynosure, Westford, MA). Three months later, the patients were treated in a single session that combined injectable neurotoxin, fillers, and fractional (Fx) CO2 laser resurfacing delivered in a novel “hammock” distribution. After two weeks, following complete re-epithelialization, the patients were started on a topical regimen that included daily use of sunscreen and antioxidants and nightly use of retinoids and peptides. This regimen was continued for a period of six months when all patients returned for final evaluation.
RESULTS: Nine months following the initiation of treatment, all patients were evaluated by the following: Global Aesthetic Improvement Scale, cervicomental angle scale, physician, and subject evaluation. Clinical improvement was evident, and often marked, for all subjects. Both physician and subject satisfaction scores were high, indicating overall satisfaction with the procedure and the outcomes. Side-effects were mild and transient; there were no incidents of adverse scarring, thermal injuries, permanent nerve injury, or dyschromia, hematomas, seromas, or infection. Subjects were likely to recommend the procedure to a friend.
CONCLUSIONS: In properly selected patients, the ACELIFT proved to be a safe and effective, minimally invasive alternative to a facelift. There was little downtime and high patient satisfaction.
J Drugs Dermatol. 2014;13(9):1038-1046.
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.
Stefanie Luebberding PhDa and Macrene Alexiades-Armenakas MD PhDa,b| |
In October 2013 the FDA approved for the first time ever an injectable dermal filler for the augmentation of age-related volume loss. This low-molecular-weight (LMW) 20mg/ml hyaluronic acid (HA) filler competes on the market with poly-L-lactic acid (PLLA) and calcium hydroxylapatite (CaHA), that have been used off-label for many years to restore age-related volume loss. The safety profile and efficacy of all three injectables has been intensively evaluated in innumerous clinical studies. However, each volume filler has its benefits and disadvantages, including usage, method of action and duration of effect that are reviewed in this article.
J Drugs Dermatol. 2013;12(12):1339-1344.
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.
J Drugs Dermatol. 2012;11(9):1053-1058.
Isabela T. Wieczorek MD,a Brian P. Hibler BS,b and Anthony M. Rossi MDc| |
J Drugs Dermatol. 2015;14(9):1043-1051.
Adam J. Friedman MD FAAD,a Erika C. von Grote PhD,b Matthew H. Meckfessel PhDb| |
J Drugs Dermatol. 2016;15(5):633-639.
Wendy E. Roberts MD| |
J Drugs Dermatol. 2014;13(4):472-482.
J Drugs Dermatol. 2012;11(9):1059-1068.
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