BACKGROUND: Hyperpigmentation is a common concern and has many causes including lentigines and melasma. Currently available
topical products for hyperpigmentation are limited by their potential for irritation, lack of demonstrated efficacy or regulatory concerns..
OBJECTIVE: To compare the efficacy of a new skin lightening product with and without iontophoresis to a known effective product
(tretinoin) and placebo on hyperpigmentation caused by lentigines and/or melasma. Secondary objectives included an assessment of
the product’s effects on the appearance of rhytides and roughness.
METHODS AND MATERIALS: Eighty subjects were randomized into one of four treatment groups: proprietary lightening product, proprietary
lightening product with iontophoresis, tretinoin 0.05% cream, or vehicle control. Seventy-four subjects completed all study visits.
Blinded assessments of subjects were performed at each visit under ambient and Wood’s light.
RESULTS: The proprietary skin lightening product improved facial hyperpigmentation versus placebo under ambient light (P = 0.05) and
Wood’s lamp (P = 0.01) examination. Tretinoin also improved facial hyperpigmentation versus placebo under Wood’s lamp (P = 0.01).
The proprietary product was better tolerated than tretinoin, with fewer subject reported side effects.
CONCLUSION: The investigational product was effective and may be better tolerated than tretinoin cream.
J Drugs Dermatol. 2015;14(1):13-18.
BACKGROUND: Hyaluronic Acid (HA) fillers are widely used for restoring facial volume.
OBJECTIVE: A 24-week study evaluated clinical efficacy with HA.
METHODS AND MATERIALS: Included were 15 healthy subjects recruited from 4 centers, between ages of 35 to 65 years, who had a
Wrinkle Severity Rating Scale (WSRS) score ≥ 3, indicating moderate volume loss. Revanesse® Ultra (Prollenium), a HA dermal filler,
was used. Primary study outcome was physicians scored facial volume correction, using the Global Aesthetic Improvement Scale
(GAIS), comparing baseline (day 0) versus 24 weeks (end) and blindly assessed photographs. Subject satisfaction and comfort was
evaluated using self-administered questionnaires at day 0 and at week 24.
RESULTS: N = 15, 13 female and 2 males with a mean age (years) of 48.52 ( SD ± 10.46) received treatment with HA and completed the
24-week study. At screening they had a moderate (mean 2.85, SD ± 0.45) WSRS score. At week 24 a market facial volume restoration
was shown and no adverse events were reported. All patients reported to be satisfied with the obtained results.
CONCLUSION: Good – excellent volume enhancement was noted almost immediately after the HA injections, improving patient reported
quality of life aspects. HA treatment was shown to be safe.
J Drugs Dermatol. 2015;14(1):19-23.
Retinol, has been shown to improve the appearance of photodamaged skin when applied topically, and is generally considered to be approximately
ten times less potent than tretinoin. To assess this theory, three cosmetic formulations containing 0.25%, 0.5%, and 1.0%
retinol were developed to correspond to the three commonly prescribed concentrations of tretinoin (0.025%, 0.05%, and 0.1%).
A randomized, double-blind, split-face comparison study was conducted to compare the three concentrations retinol (Ret) including
0.25%, 0.5%, and 1.0%, against the respective three strengths of tretinoin (Tret) 0.025%, 0.05%, and 0.1% in subjects with moderate
to severe facial photodamage. Subjects were randomized into three groups: Group 1 (Ret 0.25% vs. Tret 0.025%); Group 2 (Ret 0.5% vs.
Tret 0.05%); and Group 3 (Ret 1.0% vs. Tret 0.1%). Within each group, subjects were randomized to apply Ret on one half of the face (left
or right) and Tret on the other facial side, for a duration of twelve weeks. Clinical evaluations for efficacy and tolerability, as well as standardized
digital photographs were conducted at baseline and at weeks 4, 8, and 12. Sixty-five subjects completed the twelve-week study
(Group 1: n=24, Group 2: n=20, and Group 3: n=21). At week 12 in all treatment groups, both Ret and Tret produced statistically significant
improvements from baseline in all efficacy parameters, including overall photodamage, fine lines/wrinkles, coarse lines/wrinkles, skin
tone brightness, mottled pigmentation, and tactile roughness (all P<0.001). There were no significant differences in efficacy between Ret
and Tret in these efficacy parameters. Results from this comparison study suggest that this sustained-release retinol complex containing
multiple agents for optimal irritation control provides comparable improvements to tretinoin in the appearance of photodamage.
J Drugs Dermatol. 2015;14(1):24-30.
Rosacea is a chronic inflammatory disease with a complex pathophysiology that manifests with central facial redness with or
without papulopustular lesions. Often, patients with rosacea present with a constellation of signs and symptoms; for best results,
the treatment plan should take into account all symptoms manifesting in the individual patient. The first available pharmacologic
treatment to address the redness associated with rosacea is topical brimonidine. In the United States, brimonidine topical gel
0.33% is indicated for persistent facial erythema of rosacea; approval was based on clinically significant efficacy and good safety
data from large-scale clinical trials. Use of brimonidine in routine clinical practice has yielded new insights that elaborate on the
findings from clinical trials. For example, real-world use has shown that a percentage of patients (in our experience, approximately
10 to 20%) treated with brimonidine experience a worsening of erythema that has been called “rebound.” Our routine use of
this agent for >1 year has yielded strategies to set patient expectations, optimize treatment initiation, and minimize potential
problems; this article details those strategies. Because we believe that the term “rebound” has been used to describe several
physiologically distinct events, we have also proposed more specific terminology for such events.
J Drugs Dermatol. 2015;14(1):33-40.
BACKGROUND: Oat (Avena sativa) in colloidal form is a centuries-old topical treatment for a variety of skin conditions, including skin rashes,
erythema, burns, itch, and eczema; however, few studies have investigated the exact mechanism of action for the anti-inflammatory
activity of colloidal oatmeal.
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.
BACKGROUND: Hyaluronic acid (HA) dermal fillers are effective and safe for correction of facial rhytides. A new volumizing HA filler, 20
mg/ml HA dermal filler (Juvéderm® Voluma®, Allergan Inc., Irvine, CA), is the only HA filler with a FDA indication for facial volumization
due to age-related facial volume loss.
OBJECTIVE: Evaluate the biological properties, including biochemical, biophysical and rheological, of this new 20 mg/ml HA dermal
filler and discuss the importance of these properties in clinical applications.
METHODS AND MATERIALS: A systematic search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch,
Pascal, HCAPlus, IPA, and Dissertation Abstracts with key term “Voluma.” Four articles on the biological properties of this new 20 mg/
ml HA dermal filler were suitable for inclusion in this review.
RESULTS: Biological analysis of elasticity and viscosity values of this new 20 mg/ml HA dermal filler demonstrated intermediate
properties in three studies and high in one study compared to other HA dermal fillers. This 20 mg/ml HA dermal filler retained the
highest elasticity and viscosity values at temperature of 37°C. Histology demonstrated that this 20 mg/ml HA dermal filler has an
intermediate pattern of distribution within the superficial and deep reticular dermis.
CONCLUSION: This 20 mg/ml HA dermal filler demonstrated volumizing ability, and maintaining viscosity and free-flowing characteristics
for easy injection, tissue lifting, and molding. We hope future research incorporates biological properties analysis of this HA
dermal filler in clinical trials.
J Drugs Dermatol. 2015;14(1):50-54.
OBJECTIVE: To evaluate efficacy of efinaconazole topical solution, 10% in onychomycosis patients with early and long-standing disease.
METHODS: An analysis of 1655 patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from
two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was
complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture)
at Week 52. Three groups were compared: those with early disease (<1year), patients with a baseline disease of 1-5 years, and those
with long-standing onychomycosis (>5years).
RESULTS: The majority of patients had long-standing disease; were older, male and white. While nail involvement of the target toenail
did not differ noticeably amongst the three groups, the number of nails involved did increase progressively with disease duration. Differences
were seen in terms of infecting pathogens in early disease that might have important treatment implications. Efinaconazole
was more effective in treating early disease, however more than 40% of patients with long-standing disease were considered treatment
LIMITATIONS: A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis.
CONCLUSIONS: Treatment of onychomycosis early to avoid disease progression to other toenails is important. Once daily efinaconazole
topical solution, 10% is particularly effective in these patients.
J Drugs Dermatol. 2015;14(1):58-62.