Novel Tretinoin 0.05% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in a Hispanic Population
January 2019 | Volume 18 | Issue 1 | Original Article | 32 | Copyright © January 2019
Fran E. Cook-Bolden MD,a Susan H. Weinkle MD,b Eric Guenin PharmD PhD,c Varsha Bhatt PhDd
aSkin Specialty Dermatology and Department of Dermatology, Mount Sinai Hospital Center, New York, NY bDermatology, University of South Florida, Tampa, FL cOrtho Dermatologics, Bridgewater, NJ dDow Pharmaceutical Sciences Inc., Petaluma, CA
Abstract
BACKGROUND: Acne vulgaris (acne) is the most common dermatologic disease seen in a racially, geographically, politically, culturally, and socioeconomically diverse Hispanic population. Despite their growing demographics in the US, there are few studies evaluating acne treatment in this population. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns. The first lotion formulation of tretinoin was developed using novel polymerized emulsion technology to provide an important alternative option to treat these acne patients who may be sensitive to the irritant effects of other tretinoin formulations.
OBJECTIVE: To determine the efficacy and safety of tretinoin 0.05% lotion in treating moderate-to-severe acne in a Hispanic population.
METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Hispanic subjects (aged 11 to 50 years, N=766) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout using a 4-point scale where 0=none and 3=severe.
RESULTS: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 60.1% and 53.0%, respectively, compared with 51.1% and 38.7% with vehicle (P less than equal to 0.001) in the Hispanic population. Treatment success was achieved by 19.6% of subjects by week 12, compared with 12.7% on vehicle (P=0.015). The majority of AEs were mild and transient. There were four serious AEs (SAEs) reported (two each group) unrelated to treatment. Incidence of treatment-related AEs with tretinoin 0.05% lotion was lower than in the overall study population; the most frequently were application site pain (2.0%), dryness (1.4%), and erythema (1.2%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate at baseline and improved by week 12. There were slight transient increases in scaling and burning over the first four weeks. Hyperpigmentation severity reduced progressively with treatment.
CONCLUSIONS: Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory acne lesions in a Hispanic population. The new lotion formulation was well-tolerated, and all treatment-related AEs were both mild and transient in nature.
J Drugs Dermatol. 2019;18(1):32-38.
INTRODUCTION
Acne vulgaris (acne) is one of the most common skin diseases,1 with a significant effect on self-image and 2-4 negative impact on Quality of Life (QoL). While it is typically associated with an adolescent population, it is be- coming more prevalent in adults, especially women. Acne in Hispanics is an increasing problem, presenting unique chal- lenges. They are the fastest growing minority group in the US, and acne is the most common dermatologic diagnosis, seen in over 20% of this diverse population.5,6 Acne is also more preva- lent in Hispanic (32%) females compared with White subjects (24%).7 There are also differences between racial/ethnic groups in behaviors and attitudes about acne,8 with Hispanics reporting greater negative impact on QoL.9 Pigmentary disorders, such as postinflammatory hyperpigmentation (PIH) are of significant concern in Hispanics.10 PIH can persist for months to years after the initial lesions have cleared,2 and can be more concerning than the acne which procedes it. Persistent erythema is another complication more noticeable in Hispanics with lighter skin, as increased pigmentation can mask the erythema. An irritant contact dermatitis in these patients can be signalled by the presence of erythema, hyperpigmentation, or hypopigmentation. Treating acne, as well as early initiation of PIH treatment is important in Hispanic patients.11 However, a delicate balance exists, as cutaneous irritation from the treatment itself can cause or exacerbate PIH.2 Consequently, formulations which are less irritating may be beneficial.12 Retinoids are typically first-line therapy;2,5 an important consideration is their ability to treat both acne and PIH. By increasing
