Isolagen Modifies Acne Scar Study

The FDA has provided feedback on the Phase III program investigating Isolagen Therapy for the treatment of moderate to severe acne scars.

The agency said there are no safety issues preventing further studies but asked Isolagen to clarify certain protocol issues.

Isolagen’s two randomized, double-blind, placebo-controlled acne scar clinical trials (IT-A-008 and IT-A-009) were designed to be Phase III studies. Based on the agency’s recommendations, Isolagen said it will propose to modify IT-A-008 to be a Phase II/III study.