The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies.

BACKGROUND

Tazarotene 0.1% gel and cream are effective topical treatments for acne. Tazarotene foam, 0.1% was developed to provide an alternative, safe, and effective formulation.

OBJECTIVE

To evaluate efficacy and tolerability of tazarotene foam, 0.1% in adults and adolescents with acne vulgaris.

METHODS

Two randomized, double-blind, vehicle-controlled, parallel-group studies were conducted at 39 centers in the United States and Canada. The first study involved 744 participants and the second 742, aged 12 to 45 years, who were randomized to receive treatment with either tazarotene foam, 0.1% or vehicle foam once daily for 12 weeks. Lesion counts, Investigator's Static Global Assessments (ISGA), and Subject's Global Assessments (SGA) were evaluated at baseline and weeks 2, 4, 8, and 12. Tolerability was monitored throughout the study.

RESULTS

At week 12 in both studies, treatment with tazarotene foam led to greater decreases from baseline in mean absolute and percentage change in lesion counts (noninflammatory, inflammatory, and total), greater proportion of participants with ≥2-grade improvement in ISGA score, and greater proportion of participants with ISGA score of 0 or 1 than vehicle treatment (P<.001 for all). Only application-site skin irritation and dryness were reported by >5% of participants in active treatment groups in both studies.

LIMITATIONS

The efficacy and tolerability of tazarotene foam were not compared directly with those of other formulations.

CONCLUSION

Tazarotene foam, 0.1% significantly reduced the number and severity of acne lesions after 12 weeks and had a safe and acceptable tolerability profile.