A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Clinical Study to Compare the Safety and Efficacy of a Novel Tazarotene 0.045% Lotion and Tazarotene 0.1% Cream in the Treatment of Moderate-to-Severe Acne Vulgaris

June 2019 | Volume 18 | Issue 6 | Original Article | 542 | Copyright © June 2019

Emil A. Tanghetti MD,a Leon H. Kircik MD,b Lawrence J. Green MD,c Eric Guenin PharmD PhD,d Susan Harris MS,e Gina Martin MOT,f Radhakrishnan Pillai PhDf

aCenter for Dermatology and Laser Surgery, Sacramento, CA bIndiana University School of Medicine, Indianapolis, IN, Physicians Skin Care, PLLC, Louisville, KY, Icahn School of Medicine at Mount Sinai, New York, NY cDepartment of Dermatology, George Washington University School of Medicine, Washington, DC dOrtho Dermatologics, Bridgewater, NJ eBausch Health, Bridgewater, NJ fBausch Health Americas, Inc., Petaluma, CA

Abstract
Background: Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne). Irritation potential has limited its use.

Objective: To compare efficacy, safety, and tolerability of a novel formulation tazarotene 0.045% lotion based on polymeric emulsion technology, and tazarotene 0.1% cream in patients with moderate-to-severe acne.

Methods: A total of 210 patients, 12 years and older were randomized to receive tazarotene 0.045% lotion, tazarotene 0.1% cream, or respective vehicle in double-blind, randomized, vehicle-controlled, 12-week study evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), and acne-specific quality of life (QoL) questionnaire. Safety and cutaneous tolerability were assessed throughout.

Results: A novel tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (P=.006 and P<.001) and clearly more effective in treatment success at week 12. In addition, at less than half the concentration, tazarotene 0.045% lotion was numerically more effective than tazarotene 0.1% cream. Mean percent reductions in inflammatory and noninflammatory lesions were 63.8% and 56.9%, compared with 60.0% and 54.1% with tazarotene 0.1% cream at week 12. Treatment success assessed by the investigator or patients’ self-assessment was also numerically greater with tazarotene 0.045% lotion. There were no significant differences in patient satisfaction or QoL between the two active treatments. Both were well-tolerated, however, there were more treatment-related adverse events with tazarotene 0.1% cream (5.6% versus 2.9%); most common being application site pain.

Limitations: This study was primarily designed to direct the phase 3 program and some of the results are post hoc analyses.

Conclusions: A novel tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction, and numerically better treatment success than tazarotene 0.1% cream; with a highly favorable safety and tolerability profile in moderate-to-severe acne patients.

J Drugs Dermatol. 2019;18(6):542-548.

INTRODUCTION

Topical retinoids (eg, tazarotene, tretinoin, adapalene) have played an important role in the management of acne vulgaris (acne). They reduce visible lesions and inhibit the development of microcomedones and new lesions.1-3 Retinoids normalize the abnormal desquamation process by reducing keratinocyte proliferation and promoting differentiation,4 as well as modulating several important inflammatory pathways.4-10 Extensive clinical data have shown retinoids to be highly effective in acne, and they are recommended as the cornerstone of topical therapy.11 Comparative studies between tazarotene, tretinoin and adapalene have generally reported greater efficacy with tazarotene, but more irritation.12-20

A key aspect of acne management has been the ongoing evolution of topical treatments that use innovative delivery solutions and optimal formulations to help minimize irritation, without