The following article is part of coverage from the American Academy of Dermatology’s Annual Meeting (AAD 2020). Because of concerns regarding the coronavirus disease 2019 (COVID-19) pandemic, all AAD 2020 sessions and presentations were transitioned to a virtual format. While live events will not proceed as planned, readers can click here to view more news related to research presented during the AAD VMX 2020 virtual experience.
A novel tazarotene lotion was effective as a once-daily treatment for moderate to severe acne vulgaris, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2020, held online from June 12 to 14, 2020.
In this phase 3, double-blind, randomized clinical trial, patients aged ≥9 years were randomly assigned to receive either once-daily tazarotene 0.045% lotion (n=402) or placebo (n=411) for 12 weeks. Eligible patients had moderate to severe acne at baseline. Primary endpoints were absolute change from baseline in mean inflammatory lesion count and percentage of patients achieving treatment success. Treatment success was defined as a ≥2-grade reduction from baseline in Evaluator Global Severity Scores (EGSS) with a “clear” or “almost clear” EGSS score. Adverse events and tolerability were assessed throughout the study duration.
Of the 813 participants, 67.8% were women and 72.6% were white. Mean age was 20.6 years (range, 10-65 years). Patients in the treatment arm experienced significantly greater reductions in inflammatory and noninflammatory lesion counts than control patients (P <.001). The percentage of patients achieving treatment success at week 12 was 25.5% in the tazarotene arm, compared with 13.0% in the placebo arm (P <.001). Most treatment-emergent adverse events were of mild or moderate severity. The most frequently reported adverse events with tazarotene lotion were pain (4.6%), dryness (3.6%), erythema (2.3%), and exfoliation (2.3%) at the application site. The frequency of these side effects typically peaked at week 2 and decreased thereafter.
Per these data, tazarotene 0.045% lotion has a favorable efficacy and safety profile and may be a viable option for the treatment of moderate severe acne. Further study with longer follow-up is necessary to confirm these results.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry.
Please see the original reference for a full list of authors’ disclosures.
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Murray A, Lain E, Green LJ, Martin G, Pillai R, Guenin E. A phase 3 study (301) of tazarotene 0.045% lotion for once-daily treatment of moderate-to-severe acne vulgaris. Presented at: AAD VMX 2020; June 12-14, 2020. Abstract/Poster #15202.