Tazarotene 0.045% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in Adult Males

January 2020 | Volume 19 | Issue 1 | Original Article | 78 | Copyright © January 2020


Published online December 13, 2019

Fran E. Cook-Bolden , Michael H. Gold , Eric Guenin

aMount Sinai Health System, New York, NY bTennnessee Clinical Research Center, Nashville, TN cOrtho Dermatologics, Bridgewater, NJ

Other gender differences may be important. Women with acne were significantly more embarrassed than their male counterparts about their skin disease and sought medical care more frequently. Also, the psychological impact caused by the presence of acne seems to affect more female patients than male patients.11 In addition, adherence to medication can play an important role in acne treatment; male patients being less compliant than females,12 with side effects being the main reason for non-adherence, especially in older patients. The poor adherence of males to topical medications may also be due to their limited experience with using topical products generally.

There are no clinical studies that have specifically looked at the treatment of acne in the adult male population. There are a few studies that have reported post hoc analyses of gender as a clinically relevant outcome variable.13-16 Only one study has presented data specifically on adult males.16 A study with dapsone 5% gel in moderate acne suggested that females experienced a significantly greater reduction in acne lesions compared to male acne patients after 12 weeks treatment.13 The data were not analysed to look at age differences. A post hoc analysis reported at the same time with clindamycin phosphate 1.2%/BP 2.5% gel also looked at gender differences, as well as stratifying by age.16 The net reduction in lesion counts (active minus vehicle) was much greater in the adolescent population; and treatment success (at least a 2-grade improvement in acne severity) favored adult males and adolescent females. A subsequent study with clindamycin phosphate 1.2%/BP 3.75% gel appeared to demonstrate greater efficacy in females, but the data were only stratified by age for the females.15 One study, with adapalene 0.3% /benzoyl peroxide 2.5% gel reported comparable efficacy by gender and by age.11 No specific data on adult males was presented.

Topical retinoids have played an important role in the management of acne, supported by extensive clinical data. Tazarotene has generally been considered to be the most effective, but the less well tolerated.17-26 Recently, data on a novel formulation of tazarotene have been published.27 Tazarotene 0.045% lotion utilizes polymeric emulsion technology to provide more efficient delivery into the dermal layers, and less irritancy on application to the skin. Tazarotene 0.045% lotion was significantly more effective than vehicle in reducing lesion counts, and comparable to tazarotene 0.1% cream despite the two-fold difference in tazarotene concentrations. Tazarotene 0.045% lotion was also better tolerated.

Here we present a post hoc analysis of the two phase 3 studies looking at the efficacy of tazarotene in adult males with moderate or severe acne and comparing the data to the adolescent male population.

METHODS

Study Design and Oversight
Two multicenter, double-blind, randomized, vehicle-controlled, parallel-group phase 3 studies to assess safety, tolerability, and efficacy of tazarotene 0.045% lotion in subjects with moderate or severe acne (with an Evaluator’s Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]). Tazarotene 0.045% lotion or vehicle (randomized 1:1) was topically applied once-daily to the face (excluding mouth, eyes, inside the nose, and lips) for 12 weeks.

Subjects provided written informed consent before study-related procedures were performed; protocol and consent were approved by institutional review boards (IRBs) or ethics committees at all investigational sites. The studies were conducted in accordance with the principles of Good Clinical Practice (GCP) and Declaration of Helsinki.

Study Population
Approximately 1600 subjects (800 in each study) were planned for enrollment. The initial topical applications were made at the investigational center. Subsequently, subjects were asked to apply their daily treatment in the evening at home. They were permitted to use only approved cleansers, moisturizers, and sunscreens, and noncomedogenic makeup and shaving products. The post hoc analysis was in adult (≥18 years of age) and adolescent (<18 years) male subjects with moderate or severe acne.

Key inclusion criteria included subjects with moderate (EGSS=3) or severe (EGSS=4) acne. Specifically, subjects had 20-50 facial inflammatory lesions (papules, pustules, and nodules), 25-100 noninflammatory lesions (open and closed comedones) and two or less facial nodules. Mandatory washout periods and restrictions applied to subjects who had used previous prescription of over-the-counter acne treatments: topical astringents and abrasives (1 week); topical anti-acne products, including soaps containing antimicrobials, and known comedogenic products (2 weeks); topical retinoids, retinol, and systemic acne treatments, such as hormonal or antibiotic treatments (4 weeks); and systemic retinoids (6 months).

Efficacy assessments were carried out at screening, baseline, weeks 4, 8, and 12 (end of treatment). The EGSS was determined prior to performing lesion counts. Subjects also completed a validated Acne-Specific Quality of Life (Acne-QoL) questionnaire that asked questions pertaining to their QoL as it related to their facial acne, at baseline and week 12. Adverse events (AEs) were recorded throughout the study and cutaneous tolerability at weeks 2, 4, 8, and 12.