Barrier Therapeutics has reported successful results of a dose ranging study for its antifungal product pramiconazole, which met both primary and secondary endpoints for treatment of a common skin infection in the phase IIb trial.
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Pramiconazole met the primary endpoint of effectively treating tinea versicolor, a common skin fungal infection characterized by a discolored, scaly, itchy rash primarily on the back, chest and upper arms. In addition, the secondary endpoints of complete cure, mycological cure and investigators' global assessment achieved statistical significance.
The study results demonstrated a positive linear dose response for the primary endpoint defined as significant reduction in disease signs and symptoms, including redness, scaling and itching, and complete mycological cure.
Response rates for the primary endpoint ranged from 35% for the lowest dose to 85% for the highest dose as compared to 16% for placebo. The drug was well-tolerated across all active treatment arms, and there were no reports of drug-related serious adverse events.