Derek Ho BSa and Jared Jagdeo MD MSa,b,c
BACKGROUND: Dermal fillers are important for facial aesthetic enhancement as patients are favoring non-surgical procedures with minimal recovery time. Voluma is a volumizing hyaluronic acid filler, 20 mg/ml HA dermal filler, which was FDA-approved in 2013 as the first dermal filler for treatment of age-related volume loss in the midface.
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.
Brian S. Biesman MD FACSa and Whitney P. Bowe MDb
INTRODUCTION: Non animal stabilized hyaluronic acid (Perlane, Galderma, SA) was FDA approved in 2007 for the treatment of facial wrinkles and folds. Off-label use led to the observation that injection of Perlane in the midface improved both global aesthetic appearance
and reduced the depth of nasolabial folds. A proof-of-concept trial was undertaken to explore this clinical observation further.
METHODS: Twenty subjects with moderate midfacial volume loss and prominence of nasolabial folds underwent injection of the midface
with Perlane between May and July, 2009. The average volume administered was 3.68 +/- 0.55 ml. Assessments were performed by the injecting physician and subject self-assessment for 6 months following treatment.
RESULTS: 17 of 20 subjects completed all study visits. At the 6-month follow up visit 16 of 17 subjects were found to have clinically significant improvement of the midface and 14 of 17 subjects were found to have clinically significant improvement of the nasolabial folds. No serious adverse events occurred.
CONCLUSION: In this early stage, proof-of-concept trial, the majority of patients treated demonstrated clinically significant, aesthetically pleasing improvement 6 months after injection of Perlane in the midface.
J Drugs Dermatol. 2015;14(9):943-947.
Gabriele F. Muti MD,a Giorgio Astolfi MD,b Massimo Renzi MD,c and Pier P. Rovatti MDd
To assess the use and safety of calcium hydroxylapatite for volume restoration of the face and hands in clinical practice, subjects from four Italian aesthetic clinics who had received calcium hydroxylapatite augmentation treatment between January 2012 and December 2013 were recruited. Records were retrospectively reviewed for demographic characteristics, number of treatments, area treated, injection depth and volume, method of administration, and adverse events. A total of 1,783 treatments were administered to 800 subjects (female: 93.5%; mean age: 49.6 years). Overall, 620 (77.5%) subjects were treated over two sessions for a particular indication, and 243 (30.3%) treated over three sessions. The most frequently treated areas were the zygomatic area (men: 30.2%; women: 30.6% of all treatments), malar area (24.5% and 24.3%), and marionette lines (18.9% and 11.6%). A cannula was used for most treatments (86.7%). Injection volume ranged from 0.4 mL to 1.5 mL. Injection-site swelling and bruising occurred with 18.2% and 11.3% of treatments, respectively. Most cases resolved within one week and two weeks, respectively. No serious/unexpected adverse events occurred. In clinical practice, calcium hydroxylapatite is a versatile, well-tolerated treatment for filling folds and volume restoration of the face and hands.
J Drugs Dermatol. 2015;14(9):948-954.
Kathleen Sikora Viscusi MD and C. William Hanke MD MPH
OBJECTIVE: This case series explores the use of vismodegib to treat locally advanced basal cell carcinoma (laBCC), with a focus on tolerability,
efficacy, and outcomes after treatment cessation.
METHODS: Data from patients who underwent vismodegib treatment for laBCC at a single institution from 3/6/2012 through 3/15/2015 was utilized in this study. For all included cases, treatment responses as recorded at the first follow-up after treatment cessation were assessed and are reported as complete clinical response (CCR), partial clinical response (PCR), stable disease, or progressive disease.
In cases of CCR, clinical disease free survival (DFS) was calculated as the time from cessation of vismodegib until last available follow-up, death, or recurrence. Data pertaining to side effects and adverse events was also recorded, and results are presented using descriptive statistics.
RESULTS: A total of 24 patients and 31 tumors met inclusion criteria. CCR was observed in 17 of 31 tumors (55%), and 13 of 31 tumors (42%) demonstrated PCR. Stable disease was seen in one patient (one tumor) (3%). No cases demonstrated clinical tumor progression
during treatment. The mean clinical DFS at time of data cut off for all cases of CCR was 9.3 months (range 2-21 months). In cases of PCR, the mean reduction in tumor size was 52% (range, 11%-80%). Only two patients (8%) discontinued treatment secondary to side effects.
CONCLUSION: Each patient and each tumor responds uniquely to vismodegib treatment, including variable tumor responses and a wide range of side effects and tolerability. This study highlights important unique observations, and our data as a whole adds to previously published studies, leading to thought provoking questions. Overall, the FDA approval of vismodegib for advanced basal cell carcinoma has markedly improved the prognosis and care of affected patients.
J Drugs Dermatol. 2015;14(9):956-962.
Brian C. Schulte BSE, Wesley Wu MD, and Ted Rosen MD
Azelaic acid is a complex molecule with many diverse activities. The latter include anti-infective and anti-inflammatory action. The agent also inhibits follicular keratinization and epidermal melanogenesis. Due to the wide variety of biological activities, azelaic acid has been utilized as a management tool in a broad spectrum of disease states and cutaneous disorders. This paper reviews the clinical utility of azelaic acid, noting the quality of the evidence supporting each potential use.
J Drugs Dermatol. 2015;14(9):964-968.
OBJECTIVE: To evaluate the efficacy, safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel in the treatment of moderate and severe acne.
METHODS: Multicenter, double-blind study in 498 patients with moderate or severe acne randomized to clindamycin-BP 3.75% or vehicle,
once-daily for 12 weeks. Efficacy evaluations included inflammatory and noninflammatory lesion counts and evaluator’s global severity at baseline, and at weeks 4, 8, and 12. Adverse events (AEs) and tolerability were also assessed. This was a post hoc analysis of moderate and severe acne populations.
RESULTS: Clindamycin-BP 3.75% significantly reduced inflammatory and noninflammatory lesions in both moderate and severe acne patients compared with vehicle. More than half of the patients with severe acne (55.1%) had at least a 2-grade reduction in evaluator’s global severity score by week 12, and 30.6% of patients assessed their acne as ‘clear’ or ‘almost clear’. Clindamycin-BP 3.75% was well tolerated, with no substantive differences from vehicle; and no patient discontinued due to AEs.
CONCLUSIONS: Clindamycin-BP 3.75% aqueous gel is an effective and well-tolerated once-daily topical treatment for both moderate and severe acne
J Drugs Dermatol. 2015;14(9):969-974.
Rachel Seidel BAa,c and Ronald Moy MD FAADb,c
BACKGROUND: Recently popularized in the field of cosmetic dermatology, subcutaneous carbon dioxide (CO2) injections have been shown to improve the skin’s appearance by augmenting oxygen delivery and thereby aiding cellular metabolism and neocollagenesis. However, they carry several risks and cannot be used on the entire face, leaving them best suited for the treatment of localized skin concerns. To combat these issues, a less invasive CO2 facial suited for full-face treatment has been developed, though its efficacy in oxygenating the skin has not been thoroughly investigated.
OBJECTIVE: The aim of this study was to evaluate the ability of the CO2 facial to oxygenate the skin.
METHODS AND MATERIALS: Twelve patients were enrolled in this split-face study. They were treated one week apart with a CO2 facial on one side of the face and particle-free microdermabrasion on the other. Measurements of transcutaneous oxygen tension (tcPO2) were recorded at baseline and after each treatment. Statistical significance was assessed by comparing the average tcPO2 difference in mmHg following microdermabrasion and after a carbon dioxide facial using a 1-tailed paired t-test (α = 0.05).
RESULTS: The average increase in tcPO2 after CO2 facial treatment was statistically significantly greater (p = .0252) than after microdermabrasion.
CONCLUSION: Carbon dioxide facials improve skin oxygenation immediately following treatment, attributable to the generation of an artificial Bohr effect.
J Drugs Dermatol. 2015;14(9):976-980.
Amir Moradi MDa and Melanie Palm MDb
BACKGROUND AND OBJECTIVE: Currently there are many non-invasive radiofrequency (RF) devices on the market that are utilized in the field of aesthetic medicine. At this time, there is only one FDA cleared device on the market that emits RF energy using a non-contact delivery system for circumferential reduction by means of adipocyte disruption. Innovation of treatment protocols is an integral part of aesthetic device development. However, when protocol modifications are made it is important to look at the safety as well as the potential for improved efficacy before initiating change. The purpose of this study was to evaluate the safety and efficacy of a newly designed extended treatment protocol using an operator independent selective non-contact RF device for the improvement in the contour and circumferential reduction of the abdomen and flanks (love handles).
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.
Mauro Carducci MD,a Paolo Sergio Pavone MD,b Giuseppe De Marco MD,a Silvia Lovati MD,b
Velimir Altabas MD,d Karmela Altabas MD,d and Enzo Emanuele MDc
Recent experimental irradiation studies have shown that the addition of DNA repair enzymes (photolyase and endonuclease) to traditional sunscreens may reduce ultraviolet radiation (UVR)-induced molecular damage to the skin to a greater extent than sunscreens alone. In this 6-month, randomized, clinical study, we sought to compare the clinical and molecular effects of sunscreens plus DNA repair enzymes vs. those of traditional sunscreens alone in patients with actinic keratosis (AK). A total of 28 AK patients were randomized to topically apply sunscreens plus DNA repair enzymes (enzyme group; n = 14) or sunscreens alone (sunscreen group; n = 14) for 6 months. The main outcome measures included 1) hyperkeratosis, 2) field cancerization (as measured by fluorescence diagnostics using methylaminolaevulinate), and 3) levels of cyclobutane pyrimidine dimers (CPDs) in skin biopsies. Both regimens produced a significant reduction of hyperkeratosis at 6 months, with no difference between the two groups. Field cancerization was significantly reduced by both regimens, but the decrease observed in the enzyme group was significantly more pronounced than in the sunscreen group
(P < 0.001). At 6 months, CPDs decreased by 61% in the enzyme group and by 35% in the sunscreen group compared with baseline values (P < 0.001). These findings indicate that, despite a similar effect on hyperkeratosis, the addition of DNA repair enzymes to sunscreens was more effective in reducing field cancerization and CPDs than sunscreens alone. Taken together, our findings indicate that sunscreens plus DNA repair enzymes may be superior to traditional sunscreens alone in reducing field cancerization and UVR-associated molecular signatures (CPDs) in AK patients, potentially preventing malignant transformation into invasive squamous cell carcinoma in a more efficient manner.
J Drugs Dermatol. 2015;14(9):986-990.
Subhash J. Saxena PhD,a Deysi Duque MS,b and Michael J. Schirripa PhDb
INTRODUCTION: With many effective anti-aging solutions for the face, consumer focus is now turning to other parts of the body including
the delicate skin on the neck. This study investigates the effect of a new neck cream on the appearance of texture, fine lines and wrinkles, laxity, and hydration.
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.
Rachel Seidel BAa and Ronald L. Moy MD FAADb,c
BACKGROUND: Atrophic acne scars are a common and psychologically devastating sequela of acne vulgaris that are refractory to the vast majority of topical treatments.
OBJECTIVE: We evaluated the efficacy of a topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars.
METHODS: A single-center clinical trial was performed on nine self-selected male and female patients with Goodman & Baron grade II-IV atrophic acne scars. Subjects followed a standardized treatment regimen, including twice-daily application of EGF serum to scarred areas over 12 weeks. Subject progress was evaluated at baseline and 4-week intervals by clinical photography, Investigator Global Assessment (IGA), Goodman grade and patient self-assessment. Final patient perceptions were shared by written self-assessment at the end of the study. Before and after photographs were also evaluated by a blind investigator.
RESULTS: Eight subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 2.875 (SEM= .327) to 2.38 (SEM = .375). Mean Goodman grade was reduced from 3.00 (SEM = .309) to 2.75 (SEM = .25). Of the eight pairs of before and after photographs given to a blind investigator, five were correctly chosen as the post-treatment image. Two were assessed as “excellent” (76-100%) improvement and three were assessed as "good" (50-75%) improvement. A one-tailed paired student t-test (α = .05) using blind investigator ratings of scar severity for each before and after photograph yielded a P-value of .0019, confirming the difference as statistically significant. On final self-assessment, all but one patient reported “good” to “excellent” improvement in their scars compared to baseline. 75% of patients who received alternative treatments in prior years reported EGF serum to be more efficacious.
CONCLUSION: These results suggest that topical EGF may improve the appearance of atrophic acne scars, though further study and more objective evaluation measures are required for definitive conclusions to be drawn.
J Drugs Dermatol. 2015;14(9):1005-1010.
Michael E. Farhangian BA,a Amy J. McMichael MD,a Karen E. Huang MS,a and Steven R. Feldman MD PhDa,b,c
BACKGROUND: Alopecia Areata (AA) is a non-scarring alopecia that affects millions of Americans, however the way it is treated and which patients seek treatment is not well characterized.
OBJECTIVE: To better understand how AA was being treated in the United States, what type of patients are seen for AA, and what physicians treated them.
METHODS: We analyzed data from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) from 2001 to 2010. We tabulated patient characteristics, the physicians who treated AA and what treatments were prescribed for AA.
RESULTS: There were an estimated 2.6 million outpatient visits for AA. Patients with AA were most commonly treated by a dermatologists
(84.8%). Patients were most commonly treated with topical and injected corticosteroids (61.0%) followed by minoxidil (5.9%) and topical tacrolimus (5.7%). Males made fewer visits per 1,000 capita compared to females (P=0.01).
LIMITATIONS: The NAMCS and NHAMCS do not record severity of disease data.
CONCLUSIONS: Topical and injected corticosteroids are the mainstay of treatment for AA, however the use of steroid sparing agents such as minoxidil is low. Despite no studies demonstrating efficacy, topical tacrolimus was used almost as frequently as minoxidil.
J Drugs Dermatol. 2015;14(9):1012-1014.
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
Onychomycosis prevalence is expected to rise as the population ages and the prevalence of diabetes, peripheral vascular disease, and other significant risk factors rise. Until recently, treatment options were limited due to safety concerns with oral antifungals and low efficacy with available topical agents. Efinaconzole and tavaborole were approved by the FDA in 2014 for onychomycosis treatment and provide additional effective topical treatment options for patients with mild-to-moderate disease. Dermatologists and podiatrists both regularly treat onychomycosis, yet there are striking differences between specialties in approach to diagnosis and treatment. In order to explore these differences a joint dermatology-podiatry roundtable of onychomycosis experts was convened. Although it has little effect on mycologic cure, debridement may be a valuable adjunct to oral or topical antifungal therapy, especially in patients with greater symptom burden. However, few dermatologists incorporate debridement into their treatment plans and referral to podiatry may be appropriate for some of these patients. Furthermore, podiatrists may be better equipped to manage patients with concurrent diabetes or peripheral vascular disease and elderly patients who are unable to maintain proper foot hygiene. Once cure is achieved, lifestyle and hygiene practices, maintenance/prophylactic onychomycosis treatment, and proactive tinea pedis treatment in patients and family members may help to maintain patients’ cured status.
J Drugs Dermatol. 2015;14(9):1016-1021.
Evan A. Rieder MD,a Euphemia W. Mu MD,a and Jeremy A. Brauer MDa,b,c
Though still accounting for a small fraction of all cosmetic procedures in the United States, men are an emerging and rapidly expanding demographic in the field of aesthetic medicine. In this article we highlight the trends contributing to the rise of male aesthetic procedures
in dermatology, touching on social influences, psychological motivations, and treatment outcomes.
J Drugs Dermatol. 2015;14(9):1023-1026.
Joshua A. Farhadian,a Bradley S. Bloom,b and Jeremy A. Brauera,b,c
Aesthetics continues to be a rapidly growing field within dermatology. In 2014, Americans spent 5 billion dollars on an estimated 9 million minimally invasive cosmetic procedures. Between 1997 and 2014, the number of aesthetic procedures performed on men increased by 273%. The approach to male aesthetics differs from that of females. Men have a squarer face, a more angled and larger jaw, and equally balanced upper and lower facial proportions. Facial muscle mass, subcutaneous tissue, and blood vessel density are also increased in men relative to women. While many of the same cosmetic procedures are performed in males and females, the approach, assessment, and treatment parameters are often different. Improper technique in a male patient can result in feminizing facial features and patient dissatisfaction. With an increasing number of men seeking aesthetic procedures, it behooves dermatologists to familiarize themselves with male facial anatomy and the practice of cosmetic dermatology in this population.
J Drugs Dermatol. 2015;14(9):1029-1034.
Androgenetic alopecia is the progressive miniaturization of the scalp’s terminal follicles in aging men. Over 40% of Caucasian men develop
hair loss by the age of 40. Despite its prevalence, there are only two FDA approved medications to treat the condition. Recognizing
the unmet need, new medical, procedural, and surgical treatments are being adopted to combat progressive hair loss. This review examines emerging hair loss treatments including medical therapies that the target prostaglandins, low level light therapy, platelet rich plasma injections, and robotic hair transplantation.
J Drugs Dermatol. 2015;14(9):1036-1040.
Isabela T. Wieczorek MD,a Brian P. Hibler BS,b and Anthony M. Rossi MDc
More than ever, male patients are seeking cosmetic procedures for a variety of reasons including but not limited to: a less aged appearance, social, or work related issues. Injectable neurotoxins and fillers are appealing to the male patient for their safety, rapid results, and minimal downtime. However, methods applied to the female patient do not always translate to the male patient. In this article, we review the anatomical, biological, and behavioral differences in men. We also provide an in-depth discussion of the techniques and dosages that are used in men, emphasizing the distinctions between the sexes. While once overlooked, this gender is becoming an important demographic in cosmetic dermatology.
J Drugs Dermatol. 2015;14(9):1043-1051.
Babu Singh MD,a Terrence Keaney MD,b and Anthony M. Rossi MDc,d
Men are increasingly turning to dermatologists and plastic surgeons to request procedures that correct or enhance physical features. With the advent of this emerging new patient population, alterations in preexisting aesthetic techniques, gender-specific uses of existing
devices and overall approaches need to be revisited and adapted to obtain results that are suitable for the male patient. Recently, body contouring has become one of the most sought out procedures by men. Although the majority of clinical studies involving body contouring esthetics are performed with female patients, gains from such studies can be extrapolated to men. Body contouring can be broadly classified as non-invasive or invasive, depending on the modality used. Non-invasive contouring is most frequently performed with devices that target subcutaneous adipose with focused electrical or thermal energy, including low-level laser, cryolipolysis, ultrasonography,
and radiofrequency. Invasive body contouring modalities useful for male body contouring include liposuction, pectoral and abdominal wall etching, jawline fillers, synthetic deoxycholic acid injections, and solid silicone implants. The purpose of this review is to bring attention to the unique aspects, strategies, and modalities used in aesthetic body contouring for the male patient.
J Drugs Dermatol. 2015;14(9):1052-1059.
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
Men represent an important evolving segment of the cosmetic market. With the growing acceptability of cosmetic procedures along with societal and workplace pressure to maintain youthfulness, men increasingly seek the advice of aesthetic practitioners. Despite this so-called "Menaissance," there is a paucity of published literature regarding laser and light treatments of male skin. Herein the differences in male cutaneous physiology are addressed, followed by a review of light-based treatment of conditions largely unique to male skin, pseudofolliculitis barbae, and rhinophyma. Next, the publications related to laser treatment of male skin specifically are examined. We conclude with a discussion of personal observations derived from clinical experience with laser and light-based treatments in men.
J Drugs Dermatol. 2015;14(9):1061-1064.