Once-Daily Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Sex

August 2020 | Volume 19 | Issue 8 | Original Article | 777 | Copyright © August 2020

Published online July 23, 2020

Leon H. Kircik MDa-c, Linda Stein Gold MDd, Kenneth Beer MDe, Jerry Tan MDe, Hilary Baldwin MDg, Eric Guenin PharmD PHD MPHh, Robert Kang MSI, Johnson Varughese i

aIndiana University School of Medicine, Indianapolis, IN bPhysicians Skin Care, PLLC, Louisville, KY cIcahn School of Medicine at Mount Sinai, New York, NY dHenry Ford Hospital, Detroit, MI eUniversity of Miami Miller School of Medicine, Miami, FL fSchulich School of Medicine & Dentistry, Western University and Windsor Clinical Research Inc, Windsor, Ontario, Canada gThe Acne Treatment and Research Center, Brooklyn, NY hOrtho Dermatologics*, Bridgewater, NJ iBausch Health US, LLC*, Bridgewater, NJ *Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

Background: Two identical phase 3 randomized, double-blind, vehicle-controlled, 12-week studies (NCT03168321 and NCT03168334) demonstrated the efficacy and safety of tazarotene 0.045% lotion in participants with moderate-to-severe acne. Data from these studies were pooled and analyzed post hoc to evaluate outcomes by sex.
Methods: Patients aged ≥9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Outcomes comprised inflammatory/noninflammatory lesion counts, treatment success (proportion of participants achieving ≥2-grade reduction from baseline in EGSS and score of 0 [“clear”] or 1 [“almost clear”]), and treatment-emergent adverse events (TEAEs).
Results: A total of 1,064 females and 550 males were included in this analysis. For both sexes, least-squares mean percent changes from baseline to week 12 in lesion counts were significantly greater with tazarotene 0.045% lotion versus vehicle (inflammatory: females, -60.1% vs -52.1%; males, -53.6% vs -39.8%; noninflammatory: females, -57.6% vs -44.9%; males, -52.9% vs -36.5%; P<0.001, all). The percentage of participants achieving treatment success at week 12 was also significantly higher with tazarotene 0.045% lotion versus vehicle in females and males (P<0.001, both). Compared with tazarotene-treated males, tazarotene-treated females had significantly greater changes from baseline in inflammatory and noninflammatory lesions and a greater proportion achieved treatment success at week 12 (P<0.05, all). TEAE rates were similar between tazarotene- and vehicle-treated males; rates were higher for tazarotene-treated females than vehicle-treated females.
Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in the treatment of moderate-to-severe acne in female and male participants. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5249


Acne is a common dermatologic condition, affecting up to 85% of adolescents and young adults.1 The prevalence of adult acne appears to be increasing in both females and males; however, there are differences in treatment needs and physiology between the sexes that should be taken into account when prescribing acne treatments. While most patients experience onset during adolescence, persistent adult acne is more common in female patients.2,3 Additionally, females are more likely to experience recurrences of acne throughout their lives, requiring long-term maintenance treatment.3,4 In terms of skin physiology, males tend to have less epidermal water loss, higher sebum production, and a lower pH than females.5 In females, sebum production is not only lower, it also decreases with age leading to drier skin later in life.5 Along these lines, females are more likely to report dry, sensitive skin,4 which may become more apparent with age.6 These differences between female and male patients with acne could affect treatment efficacy, tolerability, or adherence.

Topical retinoids are the mainstay of acne treatment due to their comedolytic and anti-inflammatory properties.7 Several retinoids are commercially available (eg, tretinoin, adapalene, trifarotene, and tazarotene)1,8 but studies have shown that tazarotene 0.1% cream may be more effective than tretinoin 0.025%