This study will enroll 300 patients with moderate to severe acne at 20 investigational centers throughout the US. The study design will evaluate three dosage strengths of incyclinide and a placebo over a 12-week period with the objective of determining an optimal dose for phase III testing. The company anticipates that the results of the study will be available in the fourth quarter of 2006.
In a recent 14-patient, phase II study evaluating the potential of incyclinide to treat rosacea, patients treated with incyclinide showed a clinically and statistically significant improvement in the reduction of inflammatory lesions. The company believes that incyclinide could have a similar effect on the inflammatory lesions associated with acne.
“Based on our understanding of incyclinide’s biological properties and the success that it demonstrated in the study for patients with rosacea earlier this year, we believe there is a strong potential that it will treat acne safely and effectively,” said Dr Klaus Theobald, senior vice president and chief medical officer of CollaGenex.