Aclaris Therapeutics announced positive results from a phase 3 trial investigating a proprietary formulation of hydrogen peroxide (A-101) for the topical treatment of common warts. 

The THWART-2 (WART-302) study included 502 patients who had 1 to 6 warts at baseline. Patients were randomized to receive A-101 45% Topical Solution or vehicle twice a week over 8 weeks. The primary end point of the study was the proportion of patients whose identified common warts were determined to be clear as assessed by the Physician’s Wart Assessment (PWA) Scale at Day 60. 

Results showed that a significantly greater proportion of patients treated with A-101 45% Topical Solution reported clearance of common warts at Day 60 compared with vehicle (P<.0001). Moreover, all secondary end points (ie, complete clearance at Day 137; mean per patient percent of treated warts cleared at Day 137; clearance in patients with a single baseline wart at Day 60; time to complete clearance of warts) were statistically significantly in favor of A-101 45% Topical Solution vs vehicle. 

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Application site adverse events were reported in 53.4% of the A-101 group vs 8.4% of the placebo group. The most common adverse events were application site pain, pallor, erythema, pruritus, scabbing and erosion.

“There are no FDA approved prescription treatments for common warts and we are excited by these data and look forward to the results of the second pivotal phase 3 trial, THWART-1 (WART-301),” said Dr Neal Walker, President and CEO of Aclaris. “This treatment is self-administered twice a week for 8 weeks (a total of 16 applications) and we believe these results will be of interest to partners seeking to commercialize A-101 45% Topical Solution.”

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