Efficacy and Safety of Tazarotene 0.045% Lotion in Caucasian Adults With Moderate-to-Severe Acne
October 2022 | Volume 21 | Issue 10 | 1061 | Copyright © October 2022
Published online September 29, 2022
James Q. Del Rosso DOa,b,c, Linda Stein Gold MDd, Stephen K. Tyring MD PhDe, Joshua A. Zeichner MDf, Valerie Callender MDg,h, Zoe D. Draelos MDi, William Philip Werschler MDj, Fran E. Cook-Bolden MDk,l, Eric Guenin PharmD PhD MPHm
aJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV
bAdvanced Dermatology and Cosmetic Surgery, Maitland, FL
cTouro University Nevada, Henderson, NV
dHenry Ford Hospital, Detroit, MI
eUniversity of Texas Health Science Center, Houston, TX
fIcahn School of Medicine at Mount Sinai, New York, NY
gCallender Dermatology and Cosmetic Center, Glenn Dale, MD
hHoward University College of Medicine, Washington DC
iDermatology Consulting Services, PLLC, High Point, NC
jUniversity of Washington, School of Medicine, Seattle, WA
kPrivate Practice, New York, NY
lDepartment of Dermatology, Weill Cornell, New York, NY
mOrtho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.
Abstract
Background: While topical retinoids are a mainstay of acne treatment, acne can manifest differently in various skin types. The objective of these post hoc analyses from two pooled phase 3 studies was to examine efficacy and safety of tazarotene 0.045% and quality of life improvements in self-identified Caucasian adults with moderate-to-severe acne.
Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion (N=1,614); a subset of adults (≥18 years) who self-reported Caucasian (White) race (n=645) were examined. Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment (endpoint) success (≥2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear]). Quality of life, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were also assessed.
Results: At week 12, tazarotene lotion significantly reduced lesion counts by ~60% (least-squares mean percent changes from baseline, tazarotene vs vehicle: inflammatory, -61.2% vs -51.1%; noninflammatory, -59.7% vs -49.3%;
P<0.001, both). Significantly more participants achieved treatment success with tazarotene lotion versus vehicle (P<0.001). Numerical improvements in quality-of-life domains were observed from baseline to week 12. Most TEAEs were unrelated to treatment, and rates of moderate-to-severe erythema decreased from baseline to week 12 with tazarotene treatment.
Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated over 12 weeks and led to quality-of-life improvements in Caucasian adults with moderate-to-severe acne. These results, along with those from patients with skin of color, demonstrate that once daily tazarotene 0.045% lotion is an effective and well-tolerated treatment option regardless of race or skin color.
J Drugs Dermatol. 2022;21(10):1061-1069. doi:10.36849/JDD.6834
INTRODUCTION
Acne is a common dermatologic condition—accounting for more than 4.5 million visits to physicians in the US each year1— that affects adults and adolescents and pre-teens of all ethnicities and races.2-5 Irrespective of skin type, acne pathogenesis involves follicular hyperkeratinization, increased sebum production, proliferation of cutaneous Cutibacterium acnes (formerly Propionibacterium acnes), and inflammation.6,7
Acne presentation and associated sequelae, however, can
