Lower dose tazarotene lotion effective in acne lesion reduction
Once-daily use of tazarotene 0.045% reduced inflammatory and noninflammatory acne vulgaris lesions, according to a phase 3 study presented at the American Academy of Dermatology virtual meeting.
Tazarotene 0.045% lotion uses polymeric emulsion technology to distribute a lower dose of the drug compared to the widely used tazarotene products currently prescribed to acne vulgaris patients.
The phase 3, vehicle-controlled study randomized 813 patients into two treatment groups and evaluated progress from baseline to week 12.
Treatment success, defined as a reduction greater than or equal to a 2-grade reduction in Global Severity Score, was reported in 25.5% of patients in the treatment group after 12 weeks and 13% in the vehicle group (P < .001).
A mean percentage change in inflammatory lesions of 55.5% was recorded in the treatment group at week 12, compared to a change of 45.7% in the vehicle group. Noninflammatory lesions had a mean change of 51.4% in the tazarotene group at week 12, compared to 41.5% in the vehicle group.
“In this pivotal, phase 3 study, once-daily tazarotene 0.045% lotion was efficacious in patients with moderate-to-severe acne, providing significantly greater reductions in inflammatory and noninflammatory lesion counts and a greater proportion of participants achieving treatment success versus vehicle,” the study authors wrote.
Most treatment-related adverse events, including pain, dryness, erythema and exfoliation, were mild or moderate. Three patients in each group experienced a serious adverse event.