Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Assessment of Efficacy and Safety in Patients Aged 9 Years and Older

October 2018 | Volume 17 | Issue 10 | Original Article | 1084 | Copyright © 2018

Stephen K. Tyring MD PhD,a Leon H. Kircik MD,b David M. Pariser MD,c Eric Guenin PharmD PhD,d Varsha Bhatt PhD,e Radhakrishnan Pillai PhDe

aUniversity of Texas Health Science Center, Houston, TX bIndiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; Icahn School of Medicine at Mount Sinai, New York, NY cVirginia Clinical Research, Inc., Norfolk, VA dOrtho Dermatologics, Bridgewater, NJ eDow Pharmaceutical Sciences Inc., Petaluma, CA

Abstract

BACKGROUND: Topical tretinoin has been extensively studied in clinical trials, and its essential role in the treatment of acne vulgaris (acne) established through evidence-based guidelines. OBJECTIVE: To evaluate efficacy, safety, and tolerability of a novel tretinoin 0.05% lotion in moderate-to-severe acne in patients aged 9 years and older. Methods: A total of 1640 patients, 9-58 years of age were randomized to receive tretinoin 0.05% lotion or vehicle in two double-blind, placebo-controlled 12-week, 2-arm, parallel group studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and acne severity using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), Acne-specific quality of life (QoL) questionnaire and assessed their facial skin for shininess/oiliness improvement. The data from these two independent studies were pooled and analyzed. RESULTS: Tretinoin 0.05% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (both P less than .001) at week 12 and improving acne severity (P less than .001). At week 12, mean percent change in inflammatory and noninflammatory lesions were 52% and 46%, respectively. Treatment success (a 2-grade improvement in EGSS and ‘clear’ or ‘almost clear’ was reported in 18% of patients. Tretinoin 0.05% lotion also showed significantly greater benefits relative to vehicle control in terms of patient satisfaction (P less than .001) and acne-specific QoL domains. Tretinoin 0.05% lotion was very well tolerated with no substantive differences in cutaneous tolerability among treatment groups. No patients discontinued treatment because of adverse events. LIMITATIONS: Data from controlled studies may differ from clinical practice. CONCLUSIONS: Tretinoin 0.05% lotion provides statistically significant greater efficacy than vehicle with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. J Drugs Dermatol. 2018;17(10):1084-1091.

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INTRODUCTION

Topical retinoids (eg, tretinoin, adapalene, tazarotene) have played an essential role in the management of acne vulgaris (acne) because they reduce visible lesions and inhibit the development of microcomedones and new lesions.1,2 Retinoids normalize the desquamation process by reducing keratinocyte proliferation and promoting differentiation,3 as well as blocking several important inflammatory pathways that are activated in the pathogenesis of acne.3-7Extensive clinical data have shown that retinoids are highly effective in acne, and they are recommended as the cornerstone of topical therapy.8 However, there are a number of perceived barriers to their use. There is a common perception that they are primarily effective in comedonal acne,9 and that their use is associated with significant cutaneous irritation.10,11 Several attempts have been made in the past to alleviate the tolerability issue using novel delivery systems. A new lotion formulation of tretinoin has recently been developed leveraging polymerized emulsion technology with the aim to improve both efficacy and tolerability.Here, the pooled data from two large phase 3 clinical studies (N = 1640) where patients with moderate-to-severe acne were treated with tretinoin 0.05% lotion are presented for the first time.

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