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Novel Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Race/Ethnicity.
- Source :
-
Journal of drugs in dermatology : JDD [J Drugs Dermatol] 2020 Jul 01; Vol. 19 (7), pp. 727-734. - Publication Year :
- 2020
-
Abstract
- Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials. Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 'clear' or 'almost clear'). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated. Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P<0.05, all). Black participants had significantly greater reductions in noninflammatory lesions following treatment with tazarotene 0.045% versus vehicle (P<0.05). Treatment success rates in all subpopulations were higher with tazarotene 0.045% lotion (29.4-34.1%) versus vehicle (16.4-23.1%). TEAE rates were similar across tazarotene-treated groups and most were mild-to-moderate in severity. The incidence of hyperpigmentation decreased in black tazarotene-treated participants from baseline to week 12. Conclusions: Tazarotene 0.045% lotion demonstrated efficacy and was well tolerated across racial and ethnic subpopulations in this pooled analysis. J Drugs Dermatol. 2020;19(7) doi:10.36849/JDD.2020.5125.
- Subjects :
- Acne Vulgaris ethnology
Acne Vulgaris pathology
Administration, Cutaneous
Child
Double-Blind Method
Ethnicity
Female
Humans
Keratolytic Agents administration & dosage
Male
Nicotinic Acids administration & dosage
Severity of Illness Index
Skin Cream
Treatment Outcome
Acne Vulgaris drug therapy
Keratolytic Agents therapeutic use
Nicotinic Acids therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1545-9616
- Volume :
- 19
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Journal of drugs in dermatology : JDD
- Publication Type :
- Academic Journal
- Accession number :
- 32726105
- Full Text :
- https://doi.org/10.36849/JDD.2020.5125