Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: Findings from the 52-week open label REVEAL trial.

BACKGROUND: Limited treatments are available for persistent erythema of rosacea. OBJECTIVE: To examine the long-term safety and efficacy of oxymetazoline cream 1.0% in patients with rosacea with moderate-to-severe persistent erythema. METHODS: Patients applied oxymetazoline once daily for 52 weeks. Safety assessments included treatment-emergent adverse events (TEAEs), skin blanching, inflammatory lesion counts, telangiectasia, disease severity, and rebound effect. Efficacy was assessed by the Clinician Erythema Assessment and Subject Self-Assessment composite score at 3 and 6 hours after the dose on day 1 and at weeks 4, 26, and 52. RESULTS: Among 440 patients, 8.2% reported treatment-related TEAEs; the most common were application-site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation due to adverse events (mostly application-site TEAEs) was 3.2%. No clinically meaningful changes were observed in skin blanching, inflammatory lesions, or telangiectasia. At week 52, 36.7%, and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Less than 1% of patients experienced a rebound effect following treatment cessation. LIMITATIONS: A vehicle-control group was not included. CONCLUSION: This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea.

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.

BACKGROUND: Treatment of acne vulgaris (acne) with dapsone gel, 5% requires twice-daily dosing, and some patients may not adhere to this regimen.
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.

A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris.

BACKGROUND: Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis. OBJECTIVE: This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris. METHODS: 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments. RESULTS: Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle. LIMITATIONS: The study was conducted under controlled conditions in a relatively small population. CONCLUSION: Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.

Is there a true concern regarding the use of hair dye and malignancy development?: a review of the epidemiological evidence relating personal hair dye use to the risk of malignancy.

Many advances in the cosmetic industry have increased our ability to enhance youth and beauty. Hair-coloring products are one such innovation. Over the past several decades, a significant amount of work has been dedicated to understanding the possible long-term side effects associated with hair-dye use, specifically looking at cancer risk. This paper describes the hair-coloring process, highlights the potentially carcinogenic ingredients in various hair-dying products, and reviews the epidemiological evidence relating personal hair-dye use to the risk of developing several types of malignancies.

A Four-question Approach to Determining the Impact of Acne Treatment on Quality of Life.

Facial acne vulgaris can have profound effects on health-related quality of life. In some studies, patients with acne vulgaris reported results similar to those noted with other chronic diseases, such as asthma, arthritis, or diabetes. Clinical objective assessments alone do not adequately capture the impact of acne vulgaris severity from a patient's perspective. Health-related quality-of-life assessment is important in order to fully characterize the overall burden of disease and effectiveness of treatment as the perspectives of the patient are also taken into account. Previous studies of the impact of acne vulgaris treatment on health-related quality of life have been limited in their scope of assessment. Drawbacks of prior studies have included small numbers of patients, health-related quality-of-life parameters that were not adequately evaluated, inclusion of only a limited range of mild-to-moderate acne vulgaris severity, or being unblinded or observational in study design. The Acne Quality of Life is an acne-specific questionnaire developed to assess treatment impact on the health-related quality of life of patients with acne vulgaris. Its psychometric properties and degree of responsiveness are well-established. Improvement in Acne Quality of Life with the fixed combination clindamycin phosphate 1.2%/benzoyl peroxide 2.5% aqueous gel in the largest cohort of acne vulgaris patients where health-related quality of life was studied has been reported recently. Significant improvements in all four domains over 12 weeks were seen with clindamycin phosphate 1.2%/benzoyl peroxide 2.5% aqueous gel compared to patients treated with individual active ingredients or vehicle (p<0.001). Length and time required for completion of the 19-item Acne Quality of Life questionnaire is likely to preclude its use in clinical practice. A condensed, validated Acne Q-4 scale based on the four items most broadly representative of health-related quality of life combined with a high level of correlation to the Acne Quality of Life questionnaire has been suggested as a more realistic approach that may be applied by clinicians when managing patients with acne vulgaris. The authors present data on the effectiveness of clindamycin phosphate 1.2%/benzoyl peroxide 2.5% aqueous gel on health-related quality of life based on this Acne Q-4 scale.

The frequency of self-skin examination and full body skin examination in dermatologists.

PURPOSE: Mortalities due to skin cancer are escalating, but early detection via skin examinations can be beneficial. To date, dermatologists have not been isolated as a high-risk population for developing skin cancer, although some evidence suggests that they are a high-risk group. Therefore, the specific aims of this study were to measure the frequency at which dermatologists perform self-skin examination and receive full-body skin examination. PATIENTS AND METHODS: A sample of 476 respondents provided data for this cross-sectional, nine-item survey, which was e-mailed to all registered members in the American Society for Dermatologic Surgery. The initial invitation was sent in the summer of 2007, with reminders sent at four and eight weeks. E-mails contained a unique identifier, and each member could only respond once to the survey sent to that particular e-mail address. RESULTS: 71.7 percent of the respondents reported that they routinely gave themselves a self-skin examination, 25.4 percent reported a monthly exam, 24.5 percent every six months, 17.2 percent once per year, and 4.6 percent every five years. Performing a self-skin examination was not related to age, gender, or history of skin malignancy. Seventy-six percent of all respondents never had a full-body skin examination conducted by another dermatologist, which persisted when analyzed by age (p = 0.0490) and gender (p = 0.0184). CONCLUSION: Dermatologists are more likely to perform self-skin examination rather than visit another dermatologist for a full-body skin examination.

Effecting skin renewal: a multifaceted approach.

The skin undergoes intrinsic aging as a normal course, but exposure to ultraviolet (UV) light results in major cumulative damage that manifests as the typical aged photodamaged skin. UV irradiation produces a sequence of changes within the skin layers starting with signaling processes following DNA damage and culminating in nonabsorbed fragmentation of collagen and other proteins within the extracellular matrix. These fragments promote the synthesis of matrix metalloproteinases (MMPs) that further aggravate the damage to the ground substance and add to fragment accumulation. This study describes a unique sequential approach to controlling this photodamage - inhibition of signaling, inhibition of MMPs, proteasome stimulation and mopping up of fragments, stimulation of procollagen and collagen production, and uniform packaging of new collagen fibers. Thus, a multifaceted approach is introduced with presentation of a unique product formulation based on these research principles.