Tazarotene 0.045% Lotion for Females With Acne: Analysis of Two Adult Age Groups
June 2022 | Volume 21 | Issue 6 | 587 | Copyright © June 2022
Published online May 27, 2022
Linda Stein Gold MDa, Leon H. Kircik MDb,c,d, Hilary Baldwin MDe,f, Valerie Callender MDg,h, Emil A. Tanghetti MDi, James Q. Del Rosso DOj,k,l, Joshua A. Zeichner MDb, Fran E. Cook-Bolden MDm,n, Eric Guenin PharmD PhD MPHo
aHenry Ford Hospital, Detroit, MI
bIcahn School of Medicine at Mount Sinai, New York, NY
cIndiana University Medical Center, Indianapolis, IN
dPhysicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
eThe Acne Treatment and Research Center, Brooklyn, NY
fRobert Wood Johnson University Hospital, New Brunswick, NJ
gCallender Dermatology and Cosmetic Center, Glenn Dale, MD
hHoward University College of Medicine, Washington, DC
iCenter for Dermatology and Laser Surgery, Sacramento, CA
jJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV
kAdvanced Dermatology and Cosmetic Surgery, Maitland, FL
lTouro University Nevada, Henderson, NV
mFran E. Cook-Bolden, MD, PLLC, New York, NY
nWeill Cornell Medical College, New York, NY
oOrtho Dermatologics, Bridgewater, NJ (Ortho Dermatologics is a division of Bausch Health US, LLC)
Abstract
Background: Females aged ≥25 years may have acne with different etiology, presentation, burden, and treatment response than females 18–24 years. This post hoc analysis investigated efficacy and safety of tazarotene 0.045% lotion in females ≥18 years or ≥25 years of age.
Methods: In two phase 3 double-blind studies, participants 9 years of age and older with moderate-to-severe acne were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Pooled data were analyzed for females aged ≥18 years (n=744) or ≥25 years (n=335). Assessments included inflammatory/noninflammatory lesion counts, treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of 0 [clear] or 1 [almost clear]), Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability.
Results: At week 12, tazarotene-treated females in both age groups had greater reductions from baseline versus vehicle in inflammatory (≥18 years: 60.6% vs 53.7% [
P<0.01]; ≥25 years: 60.9% vs 57.3% [
P>0.05]) and noninflammatory lesions (59.0% vs 48.4% and 61.1% vs 48.8%;
P<0.01, both). Rates of treatment success were greater with tazarotene versus vehicle; this difference was significant for females ≥18 years. Acne-QoL improvements were similar across age groups and generally greater with tazarotene than vehicle. TEAEs were mostly mild to moderate in severity. No age-related trends for safety or tolerability were observed.
Conclusions: Tazarotene 0.045% lotion demonstrated comparable efficacy, improvement in quality of life, and safety in adult females aged ≥18 or ≥25 years with moderate-to-severe acne. This cosmetically elegant lotion is a well-studied and important treatment option for all patients, particularly adult females.
J Drugs Dermatol. 2022;21(5):587-595. doi:10.36849/JDD.6876
INTRODUCTION
Acne is often regarded as an adolescent condition, but its frequency among adults is increasingly common.1 Acne among adult females is especially problematic; prevalence of acne is higher than in males,2 and older age and female gender are both associated with greater impacts of acne on quality of life.3,4 There is no age that defines a cutoff between adolescent and adult acne, but adult females 18-24 years old may be considered in a “transition period†wherein acne is more adolescent in nature (eg, “post-adolescent acneâ€).1,5 Acne in females ≥25 years old (“adult female acneâ€) may be a
