A large Phase II Clinical Trial for treating rosacea with Aczone is looking for participants. The trial aims to compare Aczone (5% topical dapsone gel) with the vehicle and Metrogel 1%.
The purpose of this study is to evaluate the safety and effectiveness of ACZONE gel compared to placebo (inactive substance), MetroGel and a combination of ACZONE gel and MetroGel for the treatment of rosacea.
ACZONE gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA.
Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12
The study was hoping for 400 participants at 27 centres and was scheduled to start in November 2005, and complete in November 2006.
Contact information for each center is available at the ClinicalTrials.gov website.
The manufacturers of Aczone, QLT, mention the following at their website ;
QLT recently re-acquired full worldwide marketing rights for Aczone. The product was approved by the FDA, with a label restriction, in mid-2005. We are proceeding with a Phase IV post-approval trial with a goal to have the restriction removed. The trial began in the fourth quarter of 2005.
Aczone is also being investigated for its potential in the treatment of rosacea. A Phase II study began in the fourth quarter of 2005 to evaluate the product’s safety and efficacy in humans.
