USA-based drugmaker CollaGenex Pharmaceuticals says that data from a study of its developmental acne treatment incyclinide indicate that the drug brings about a dose-dependant response, and that it has a safety profile similar to placebo. The firm explained that, while the program was not designed to demonstrate therapeutic efficacy, the results did show a statistically-significant clinical benefit at certain dosages, compared with placebo.
The double-blind, placebo-controlled study enrolled a total of 302 acne sufferers at 27 centers across the USA. Participants were randomized to receive one of three doses of the drug (5mg, 10mg or 20mg) or placebo, on a daily basis for 12 weeks. The program's primary endpoint was defined as the reduction in inflammatory lesion count from baseline.
The results showed that, while 10mg per day was the minimum effective dose, the 20mg formulation of the drug brought about greater therapeutic benefit and was well tolerated. CollaGenex said that it would continue to optimize the trial, and would now focus on identifying the maximum effective dose.
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