Findings from a recent pooled analysis showed the new polymeric once-daily tazarotene 0.045% lotion formulation was safe, effective, and well-tolerated among pediatric patients. The findings were published in the Journal of Drugs in Dermatology.
Although topical tazarotene is safe and effective for acne, irritation associated with the product limits its use, the researchers said. They sought to determine whether a new formulation of tazarotene 0.045% lotion improved the tolerability of the product while maintaining its safety and efficacy using data from two phase 3 double-blind, vehicle-controlled studies that included participants with moderate to severe acne aged 10 to 13 years (n=136) and aged 14 to 17 years (n=548).
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In both studies, participants were randomly assigned to receive either once-daily tazarotene 0.045% lotion or vehicle for 12 weeks. Efficacy was evaluated based on changes from baseline in inflammatory and noninflammatory lesions and treatment success, defined as a 2-grade reduction in Evaluator Global Severity Score and a clear/almost clear score, at week 12. In addition, quality of life and adverse events were assessed.
For both age groups, the mean percent reductions in inflammatory and noninflammatory lesion counts at week 12 were significantly greater among participants in the tazarotene group compared with those in the vehicle group, the researchers said. Compared with the vehicle group, more participants in both age groups treated with tazarotene achieved treatment success, they added. There were no significant differences in lesion counts and treatment success between the age groups treated with tazarotene.
In addition, participants in both age groups treated with tazarotene reported improved quality of life scores in most domains compared with the vehicle group. Most of the reported treatment-related adverse events were mild or moderate in both age groups, the researchers observed.
“Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne,” they concluded.
Eichenfield LF, Tanghetti EA, Guenin E, Martin G, Pillai R. New polymeric once-daily tazarotene 0.045% lotion formulation for moderate-to-severe acne: pooled phase 3 pediatric analysis. J Drugs Dermatol. 2020;19(6):602-610. doi:10.36849/JDD.2020.4959