Journal of drugs in dermatology: JDD

Publisher: Strategic Communication in Dermatology


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    Journal of drugs in dermatology (Online), JDD
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    Document, Periodical, Internet resource
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    Internet Resource, Computer File, Journal / Magazine / Newspaper

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Resveratrol is an effective anti-aging molecule with diverse biologic activity. It functions as a dual antioxidant that can neutralize free radicals and increase intrinsic antioxidant capacity. Additionally resveratrol increases mitochondrial biogenesis and has anti-inflammatory, anti-diabetic, and anti-cancer activity. In this paper we will focus on the use of topically applied resveratrol using a proprietary blend containing 1% resveratrol, 0.5% baicalin, and 1% vitamin E. This stabilized high concentration formulation demonstrates percutaneous absorption and alterations in gene expression such as hemoxygenase-1 (HO-1), vascular endothelial growth factor (VEGFA), and collagen 3 (COL3A1). Clinical assessment showed a statistically significant improvement in fine lines and wrinkles, skin firmness, skin elasticity, skin laxity, hyperpigmentation, radiance, and skin roughness over baseline in 12 weeks. Ultrasound measurements in the periorbital area showed an average improvement of 18.9% in dermal thickness suggesting significant dermal remodeling. These studies confirm that topical resveratrol, baicalin, and vitamin E are valuable ingredients that can be used for skin rejuvenation
    Journal of drugs in dermatology: JDD 12/2014; December 2014(Issue 12):Volume 13.
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    ABSTRACT: BACKGROUND: Effective transungual delivery of topical antifungal agents in onychomycosis has been hampered by poor nail permeation. To be effective they must have antifungal efficacy, and effectively permeate through the dense keratinized nail plate to the site of infection in the nail bed and nail matrix. The therapeutic efficacy of efinaconazole topical solution, 10% has been established in two phase 3 clinical trials in distal lateral subungual onychomycosis. OBJECTIVE: To investigate the transungual delivery of efinaconazole in onychomycosis patients and its fungicidal activity in the toenail. METHODS: Concentrations of efinaconazole were determined as part of a multi-center, open label study in forty onychomycosis patients following repeated application of efinaconazole topical solution, 5% and 10% to the toenails over 28 days, with a 2-week follow-up. Fungicidal activity against T. rubrum in the ventral layer of human nails was determined using an in vitro human nail infection model (ChubTur®). RESULTS: Efinaconazole concentrations in the nail were four orders of magnitude higher than MIC values of efinaconazole against dermatophytes. Further, nail drug concentrations were not influenced by the presence of disease or nail thickness, and maintained at high antifungal levels post-treatment. Efinaconazole was effective in reducing fungal viability, suggesting that sufficient amounts of efinaconazole were being delivered into the ventral layer of the nail plate. CONCLUSIONS: Effective transungual delivery of efinaconazole was demonstrated. The high efinaconazole concentrations in patient toenails and fungicidal activity in vitro potentially contribute to the clinical efficacy reported in phase 3 studies.
    Journal of drugs in dermatology: JDD 11/2014; 13(11):2014.
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    ABSTRACT: This study aimed to evaluate the effects of cosmetic formulations containing green tea (GT) and/or Ginkgo biloba (GB) extracts by preclinical and clinical studies. For the preclinical study, histological analysis was performed after 5 day-period of formulations application on the dorsum of hairless mice. For the clinical study, the formulations were applied on the forearm skin of 48 volunteers, and assessed before and after 3 hours and after a 15 and 30 day-period of application. Histological analysis showed that the formulation with GT (FGT) and the association of GT and GB (FBlend) significantly enhanced viable epidermis thickness and the number of cell layers, suggesting a moisturizing effect in skin deeper layers and increased cell renewal. The clinical efficacy studies showed that the extracts had a moisturizing effect and improved skin microrelief. In addition they synergistically acted on the skin elasticity and skin barrier function. In conclusion, the formulation containing a combination of green tea and Ginkgo biloba extracts effectively improved skin conditions and the effect of formulation FBlend on the improvement of skin elasticity was more pronounced. Finally, the results of the present study revealed other important clinical benefits of Ginkgo biloba and green tea extracts on the skin besides their already known antioxidant action. J Drugs Dermatol. 2014;13(9):1092-1097.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1092-1097.
  • Journal of drugs in dermatology: JDD 09/2014; 13(9):1015.
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    ABSTRACT: To evaluate efficacy, safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel in moderate to severe acne vulgaris. METHODS: A total of 498 patients, 12-40 years of age, were randomized to receive clindamycin-BP 3.75% or vehicle in a double-blind, controlled 12-week, 2-arm study evaluating safety and efficacy using inflammatory and noninflammatory lesion counts, Evaluator Global Severity Scores (EGSS) and subject self-assessment (SSA). In addition, patients completed a patient satisfaction survey (PSS), acne-specific QoL questionnaire, and assessed their facial skin for shininess/oiliness. RESULTS: Clindamycin-BP 3.75% demonstrated statistical superiority to vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Clindamycin-BP 3.75% showed greater efficacy relative to vehicle in assessments of skin oiliness, SSA and PSS. No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment with Clindamycin-BP 3.75% because of adverse events. LIMITATIONS: Data from controlled studies may differ from clinical practice. It is not possible to determine the contributions from the individual active ingredients. CONCLUSIONS: Clindamycin-BP 3.75% provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile. J Drugs Dermatol . 2014;13(9):1083-1089.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1083-1089.
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    ABSTRACT: To assess the potential efficacy, safety, and optimal dosing concentration of tavaborole, a novel, boron-based pharmaceutical agent with broad-spectrum antifungal activity, for the treatment of onychomycosis of the toenail due to dermatophytes. METHODS: One double-blind, randomized, vehicle-controlled study (study 1) and two open-label studies (studies 2 and 3) examined the efficacy, safety, and optimal dosing concentration of tavaborole topical solution applied once daily or three times weekly for 180 days at concentrations of 1.0%, 2.5%, 5.0%, or 7.5%. Patient cohort 3 of study 2 received open-label tavaborole 5.0% once daily for 360 days. All three studies assessed day 180 treatment success, defined as complete or partial clinical evidence of clear nail growth plus negative fungal culture. RESULTS: A total of 336 patients were included in the intent-to-treat (ITT) or modified ITT populations and efficacy analyses across the 3 studies. In study 1, treatment success rates at day 180 were higher with tavaborole 2.5%, 5.0%, and 7.5% vs vehicle (27%, 26%, and 32% vs 14%, respectively; slope P =0.030). In cohort 3 of study 2, 7% of patients achieved treatment success with tavaborole 5.0% at day 360. Negative culture rates at day 180 in study 1 were numerically higher for tavaborole 2.5%, 5.0%, and 7.5% vs vehicle (slope P =0.046). Application-site reactions of general irritation, erythema, scaling, and stinging/burning were most common with tavaborole 7.5%, were generally mild to moderate, and resolved with treatment discontinuation and/or a reduction in dosing frequency. No systemic safety concerns were observed. CONCLUSION: Tavaborole solution demonstrated favorable efficacy and safety in phase 2 clinical studies. Based on these findings, tavaborole topical solution, 5% was further investigated in larger, more definitive phase 3 studies. Results from these completed phase 3 studies will provide additional evidence regarding the safety and efficacy of tavaborole in the treatment of toenail onychomycosis. J Drugs Dermatol . 2014;13(9):1124-1132.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1124-1132.
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    ABSTRACT: Diaper dermatitis is the most common dermatologic disorder of infancy. Its cause can often be determined clinically based on the clinical presentation. Primary diaper dermatitis is associated with irritants and spares the deep skin folds. Secondary diaper dermatitis is most often caused by Candida yeast overgrowth and typically presents as a well-defined area of beefy red erythema covering the diaper area and including the deep folds of skin with hallmark satellite pustules. Other causes include seborrheic dermatitis, psoriasis, acrodermatitis enteropathica, allergic contact dermatitis, Langerhans cell histiocytosis, and, in the setting of a primarily pustular eruption, bacterial folliculitis. A simple potassium hydroxide preparation (KOH) can confirm the diagnosis of candida diaper dermatitis and guide proper treatment.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1153-4.
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    ABSTRACT: Skin cancer is the most commonly diagnosed cancer in the United States. A number of UV protection programs have been developed and initiated both globally and domestically, and this article will review and assess the effectiveness of each of these programs. The programs reviewed in this article target grade school aged children, as this is a time when adult health behaviors are being formed. Among these programs, multiunit programs were more effective at changing behavior as they were given over a longer period of time with more frequent interventions and included various learning techniques. J Drugs Dermatol . 2014;13(9):1099-1103.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1099-1103.
  • Journal of drugs in dermatology: JDD 09/2014; 13(9):1016-1018.
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    ABSTRACT: The etiology of aging human skin includes intrinsic physiologic changes greatly accelerated by photoaging, predominantly through exposure to UV light. Consumer interest and demand for anti-aging skin care products is extremely high especially in light of aging populations. Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects. A proprietary tissue engineering technology has been developed to produce a soluble human extracellular matrix material with growth factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension. This human cell-conditioned media (hCCM) contains a variety of growth factors and cytokines similar to those found in fetal cells and has been incorporated into a topical preparation for use in facial wound healing (after laser resurfacing procedures) and improving the appearance of aging skin. The objective of this study was to observe the effects of an MRCxTM-containing topical skincare regimen on subjects with demonstrated aging skin damage (photodamage) when used consistently over a 3 month time period. METHODS: Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a 5-point scale. Subjects' self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to each study visit for investigator's assessments and to end-of-study for self-assessments were calculated. RESULTS: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects' self-assessments were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly) with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events were recorded during the study. CONCLUSIONS: Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years as measured by both investigator assessments and subjects' self-assessments. J Drugs Dermatol. 2014;13(9):1074-1081.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1074-1081.
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    ABSTRACT: This study investigates the efficacy, tolerance, and usability of a single product containing cycloastragenol, growth factors, peptides, and antioxidants to decrease the visible signs of aging, including fine lines, and wrinkles, texture, pore size, elasticity, skin color/clarity, redness, hydration, and overall skin quality. 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.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1135-1139.
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    ABSTRACT: Atopic dermatitis is a common skin disease characterized by eczematous eruptions and impaired skin barrier function. Patients, as well as their families, frequently report reductions in quality of life. Pruritus, lack of sleep, and impaired social functioning all contribute to this reduction. A skincare regimen of gentle cleansing and daily moisturization is integral to managing atopic dermatitis. While there are a multitude of reports supporting the use of moisturizers, there is a paucity regarding the use of cleansers, especially cleansers formulated with ingredients known to improve skin hydration. A clinical study was conducted to assess the tolerability and cosmetic acceptability of a body wash formulated with the filaggrin break-down products arginine and pyrrolidone carboxylic acid in subjects with atopic dermatitis-prone skin (Cetaphil® RestoraDerm® Body Wash). The results of this study indicate that Cetaphil RestoraDerm Body Wash was well tolerated, reduced itch, improved quality of life, and was well-liked by subjects with atopic dermatitis-prone skin. J Drugs Dermatol. 2014;13(9):1108-1111.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1108-1111.
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    ABSTRACT: Cervicofacial aging is often characterized by a combination of skin and subcutaneous tissue laxity, midfacial deflation, an accumulation of excess submental fat, an obtuse cervicomental angle, jowls, and rhytides of the face and neck. Traditional treatment, and the "gold standard" against which other treatments are compared, is a facelift. 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) CO<sub>2</sub> 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.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1038-1046.
  • Journal of drugs in dermatology: JDD 09/2014; 13(9):1013-1014.
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    ABSTRACT: Hyaluronidase (HA) degrades hyaluronic acid, allowing flexibility in the use of hyaluronic acid-based fillers commonly used in facial correction. Potentially differing properties of available hyaluronidases and fillers may influence their interaction, leading to important differences in ultimate cosmetic results. This study examines the physical properties of various fillers after exposure to commonly available hyaluronidases in vitro to better inform their in vivo clinical use. METHODS: Four commonly used HA fillers were exposed to varying concentrations of Vitrase (ovine testicular hyaluronidase) and Hylenex (human recombinant hyaluronidase) in vitro. The gross properties of these fillers were then observed to evaluate time- and dose-response; photographs were obtained to allow visual comparison at 1 minute and 5 minutes post-exposure. RESULTS: At a concentration of 0.1 mL Vitrase to 0.2 mL filler, Restylane dissipated most followed by Juvéderm; Belotero most retained its form. Hylenex at the same concentration showed similar results, again affecting Restylane most and Belotero least. Response to treatment with both hyaluronidases increased substantially over time, increasing progressively from exposure to 5 minutes post-exposure. When exposed to Hylenex at 15 U and 30 U to 0.2 mL filler, Belotero retained its form most, followed by Juvéderm, Juvéderm Voluma, and then Restylane. The effects on filler structure increased with 30 U concentration vs 15 U concentration of Hylenex. DISCUSSION: Available hyaluronidases and HA fillers appear to have differing physical properties that influence their interaction in a time and dose-dependent manner. Knowledge of the ways in which specific fillers interact with different hyaluronidases may help achieve desired cosmesis when aiming to adjust delicate facial fillers. J Drugs Dermatol . 2014;13(9):1053-1056.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1053-1056.
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    ABSTRACT: The eutectic mixture of lidocaine and prilocaine (EMLA, APP Pharmaceuticals, LLC.) is an anesthetic cream frequently used by dermatologists. Although side effects of EMLA are usually mild local skin reactions (ie, edema, pallor, erythema), more severe complications can be encountered including methemoglobinemia, central nervous system toxicity, and cardiotoxicity. This article reviewed the literature regarding risk of systemic toxicity associated with use of EMLA in the pediatric and adult population. All 12 clinical trials evaluating the safety of EMLA in either the pediatric or adult population generally followed dosing and administration guidelines set by the manufacturer and reported clinically insignificant plasma levels of methemoglobin, lidocaine, prilocaine, and their respective metabolites. To date, nine pediatric cases and three adult cases of systemic toxicity associated with EMLA have been published. Possible factors that contributed to the development of systemic toxicity include excessive amount of EMLA, large application area, prolonged application time, diseased and/or inflamed skin (eg, vascular malformations, molluscum contagiosum, eczema, previously abraded skin), age less than 3 months, prematurity, and concomitant use of a methemoglobin-inducing agent. Recommendations are provided on how to safely use EMLA to minimize the risk of systemic toxicity. J Drugs Dermatol. 2014;13(9):1118-1122.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1118-1122.
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    ABSTRACT: Multiple devices are currently on the market that employ radiofrequency to non-invasively treat skin laxity and wrinkle reduction. The study device was a unique monopolar radiofrequency device FDA cleared for the treatment of wrinkles and rhytids. The delivery system allows constant monitoring of the real-time local skin impedance changes, which allows radiofrequency energy to be more uniformly dosed over an entire treatment area. 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.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1112-1117.
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    ABSTRACT: A quantitative numerical method for assessing the extent and duration of the inhibitory action of botulinum neurotoxin type A on mimetic muscles would potentially enable more detailed evaluation of the overall efficacy of this aesthetic treatment. AIM: To evaluate skin displacement analysis (SDA) as a tool for assessment of the extent and duration of effect of incobotulinumtoxinA on mimetic muscles in the glabellar region in routine daily practice. METHODS: A total dose of 30 U incobotulinumtoxinA was injected into the fronto-glabellar region of 16 subjects. SDA was performed at baseline and during onset and recovery from incobotulinumtoxinA treatment at various timepoints up to 24 weeks after treatment. The reference point for SDA was located at the upper margin of the eyebrow, 30 mm lateral to the median line. To correlate and validate SDA results, semi-quantitative wrinkle score assessments were performed in parallel. RESULTS: At baseline, the mean horizontal skin displacement was 5.4 mm (standard deviation: ±1.4 mm). During onset of action after treatment, skin displacement values decreased from baseline (100%) by 46%, 85%, and 90% at day 2, week 1, and week 2, respectively. During recovery from incobotulinumtoxinA action, skin displacement values increased to 33%, 50%, and 93% of the baseline value at 6, 12, and 24 weeks after treatment, respectively. The inhibitory effect of incobotulinumtoxinA was highly variable among subjects, ranging from 25% to 68% of the baseline value 12 weeks after treatment. Overall agreement between SDA values and wrinkle scores was good. CONCLUSION: SDA represents a novel, objective method for the quantitative evaluation of the effect of incobotulinumtoxinA on mimetic muscles underlying the fronto-glabellar region, and showed good correlation with wrinkle score assessments. Both SDA and wrinkle score indicated the persistence of treatment effects 24 weeks after injection. J Drugs Dermatol . 2014;13(9):1067-1072.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1067-1072.
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    ABSTRACT: Over the last few years, there have been a number of important changes in how we appreciate and understand the aging face. Volume loss is now recognized as a major component of facial aging. Treatment options that replace lost volume are increasingly used for recontouring and rejuvenation of the aging face. In this review we present and discuss the European Expert Group recommendations on the ideal use of the unique collagen stimulator, poly-L-lactic acid (PLLA, Sculptra®, Sinclair Pharmaceuticals) for facial rejuvenation lasting up to 25 months. Optimal results are achieved based on a detailed knowledge of facial anatomy, correct treatment procedure, specifically the right dilution, the correct injection technique, as well as appropriate patient aftercare. PLLA is an effective and safe collagen stimulator that treats the whole face. PLLA is simple to use, provides the foundation for facial rejuvenation, is easy to combine with other treatments, and gives long-lasting effects with a high level of patient satisfaction. J Drugs Dermatol. 2014;13(9):1057-1066.
    Journal of drugs in dermatology: JDD 09/2014; 13(9):1057-1066.