Photocure has completed patient enrolment according to schedule in its Phase IIb study using Visonac, a topical acne treatment.
The Phase IIb trial is a randomised, double-blind, placebo-controlled study in patients with moderate-to-severe acne vulgaris. It will measure safety and efficacy in patients aged 12 to 35 years, who will receive four treatments over a six-week period. The cream is applied to the acne area, and after a short incubation time, the skin is illuminated with red light. A total of 15 office-based dermatology practices and hospitals in the US have recruited 150 patients to the study. The results are anticipated in the third quarter of 2012 and will support the design of the pivotal Phase III studies in the US and Europe.
Visonac is being developed as the first photodynamic therapeutic option for the treatment of acne, which can be administered in dermatology offices. By avoiding the risks of increased antibiotic resistance from long-term exposure, and providing an alternative to isotretinoin, Visonac has the potential to satisfy a high unmet medical need. Clinical proof of concept has previously been demonstrated with an "excellent" safety profile and minimal patient down time.
The Visonac cream is applied to the acne area, and after a short incubation time, the skin is illuminated with red light. The mechanism of action appears to involve killing of bacteria as well as specific action on sebaceous glands and inflammatory cells.