The efficacy of tazarotene 0.045% lotion for the treatment of acne vulgaris was supported by study data published in the Journal of Drugs in Dermatology. Results were consistent in patients of different racial/ethnic subgroups.
This post-hoc analysis used data from 2 phase 3, double-blind, randomized controlled trials of tazarotene 0.045% lotion. Patients with moderate to severe acne vulgaris were randomly assigned 1:1 to receive tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Demographic data were extracted at baseline. Inflammatory and noninflammatory lesions were counted at baseline and 12 weeks. Treatment success was defined as a 2-grade reduction from baseline in Evaluator’s Global Severity Score and clinician-defined “clear” or “almost clear” skin. Treatment-emergent adverse events were assessed throughout the study. Analyses were segmented by race (White vs Black) and ethnicity (Hispanic vs non-Hispanic) due to differential acne presentation across skin types and tones. Prior research has shown that Black women with acne are at higher risk for dyspigmentation and scarring compared with their White counterparts. Similarly, postinflammatory hyperpigmentation is frequently reported by patients of color who experience acne. Investigators sought to assess the efficacy and safety of tazarotene lotion for patients of all skin tones.
Overall, 799 patients received tazarotene 0.045% lotion and 815 received vehicle lotion. The majority of patients were White (n=1191) and non-Hispanic (n=1262), and 262 and 352 were Black and Hispanic, respectively. Black participants had a higher mean age than White participants (24.0 ± 9.3 years vs 19.6 ± 6.0 years) and were more likely to be women (78.2% vs 63.2%). Demographic characteristics were comparable in Hispanic and non-Hispanic participants, although the non-Hispanic subgroup had a higher percentage of patients reporting as Black or Asian race. The majority of all participants were women.
At week 12, tazarotene 0.045% lotion was associated with significant reductions in inflammatory and noninflammatory lesions in all patient groups (all P <.05). The greatest different in noninflammatory lesion count between tazarotene and placebo groups was observed in Black patients (P <.05). Treatment success was more common in the tazarotene group vs vehicle in White (31.2 vs 16.7%; P <.001), Hispanic (34.1 vs 23.1%; P <.05), and non-Hispanic (19.4 vs 16.4%; P <.001) patients. In Black patients, the percentage achieving treatment success was higher with tazarotene vs placebo, although the different was not statistically significant (29.6 vs 19.6%; P >.05).
Treatment-emergent adverse events occurred at similar rates across patient subgroups (range, 20.2-28.7%). Adverse events were more common in the tazarotene group, although they also occurred in patients receiving placebo. The majority of adverse events were mild to moderate in severity; the most common events were application site pain, dryness, and exfoliation.
Overall, tazarotene 0.045% lotion improved acne symptoms and was well-tolerated, regardless of patient race or ethnicity. However, the relatively small number of Black and Hispanic participants limited statistical power. In addition, racial identification does not necessarily reflect skin color or characteristics; results must be extrapolated with care. “Tazarotene 0.045% lotion does not appear to induce post-inflammatory hyperpigmentation and may be an effective and well tolerated treatment option for patients with skin of color,” investigators wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry.
Please see the original reference for a full list of authors’ disclosures.
Bhatia N, Weiss JS, Sadick N, et al. Novel polymeric tazarotene 0.045% lotion for moderate-to-severe acne: pooled phase 3 analysis by race/ethnicity. J Drugs Dermatol. 2020;19(7):727-734.