Tazarotene 0.045% Lotion for Moderate-to-Severe Acne Patients: Pooled Phase 3 Analysis by Age and Sex

June 2021 | Volume 20 | Issue 6 | Original Article | 608 | Copyright © June 2021

Published online May 28, 2021

Lawrence J. Green MDa, James Q. Del Rosso DOb, Emil A. Tanghetti MDc, Eric Guenin PharmD PhD MPHd

aDepartment of Dermatology, George Washington University School of Medicine, Washington, DC
bJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV
cCenter for Dermatology and Laser Surgery, Sacramento, CA
dOrtho Dermatologics,* Bridgewater, NJ

*Ortho Dermatologics is a division of Bausch Health US, LLC.

Background: Two identical phase 3 trials (NCT03168321 and NCT03168334) and pooled post hoc analyses have established efficacy and safety of a polymeric tazarotene 0.045% lotion formulation in patients with moderate-to-severe acne. Presented here are post hoc analyses that further examine efficacy and safety of tazarotene 0.045% lotion by age and sex.
Methods: Patients aged ≥9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were equally randomized to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Efficacy outcomes included inflammatory/noninflammatory lesion counts and treatment success (proportion of participants achieving ≥2-grade reduction from baseline in EGSS and score of 0 [clear] or 1 [almost clear]). Adolescent and adult females (n=1,013) and males (n=529) were subdivided into 3 age groups: 13–19, 20–29, and ≥30 years.
Results: At week 12, large least-squares mean percent reductions in inflammatory and noninflammatory lesions were observed across all 3 tazarotene-treated age groups in males and females (range, -50.2% to -64.8%). Treatment success rates ranged from 23.6% to 38.4%. Across all efficacy assessments, significant differences between tazarotene and vehicle (P<0.05) were generally observed in the younger male and female participants (13–19 and 20–29). No notable age-related patterns were found for safety outcomes, though tazarotene-treated males of all age groups reported fewer adverse events than females.
Conclusions: Tazarotene 0.045% lotion is efficacious and well tolerated in female and male adolescents and adults with moderate-to-severe acne.

J Drugs Dermatol. 2021;20(6):608-615. doi:10.36849/JDD.6070


Sex and age are known to have a potential impact on the clinical effectiveness and tolerability of topical retinoid therapies for acne. Males tend to exhibit less epidermal water loss, higher sebum production, and a lower skin pH than females.1 Persistent and recurrent adult acne are more common in females, potentially requiring long-term maintenance treatment.2,3 Adult females are also more likely to have dry, sensitive skin which increases the likelihood of the cutaneous irritation associated with topical treatments.2,4

Retinoids target multiple pathophysiological factors in acne, demonstrate unique pharmacologic effects that modulate acne pathogenesis, and are well-recognized to “have an essential role in treatment of acne.”2 Amongst retinoids, studies have shown that tazarotene 0.1% cream may be more effective than tretinoin 0.025% gel or adapalene 0.1% or 0.3% gel in treating acne.5-7 Efficacy and safety of topical retinoids are well established, supporting their class A recommendation for acne vulgaris treatment.8 Traditionally, the most common adverse effects associated with retinoid use, such as irritation and dryness, usually occur in the first few weeks of treatment, especially at higher concentrations, though skin type and vehicle formulation can significantly impact visible manifestations of skin irritation.4,9 To address tolerability issues, a tazarotene 0.045% lotion formulation was developed utilizing polymeric emulsion technology allowing for more uniform skin distribution and increased absorption of ingredients.10 This easily spreadable lotion formulation allows for a lower effective tazarotene concentration, which when combined with optimized delivery of active and hydrating ingredients, appears to improve tolerability.10,11

Previous phase 3 pooled data have shown that tazarotene 0.045% lotion is efficacious and well tolerated.12 Subanalyses by race, ethnicity, sex, and age have also shown consistent results.13-15 Presented here are discrete age-by-sex analyses in