Isolagen initiates a Phase III clinical program to investigate Isolagen Therapy for the treatment of moderate to severe acne scars. Isolagen also has a pivotal Phase III clinical program underway to evaluate the Isolagen Therapy in treating nasolabial folds, or wrinkles.
"Millions of people in the U.S. suffer from acne which often scars, a condition that can be very distressing and difficult to treat as there are few options currently available," said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer of Isolagen. "We are pleased to be initiating this important clinical development program which we believe will address this largely unmet medical need."
Two randomized, double-blind, placebo-controlled trials will evaluate the safety and efficacy of Isolagen Therapy in patients with moderate to severe acne scarring on both sides of the face. All patients in the study will receive active treatment on one side of the face and placebo on the other, serving as their own control subjects. The patients will receive three injections, two weeks apart, and be followed for a four month period after final injection.
About Acne Scarring
Acne is one of the most common skin disorders in the United States. Over time, as facial tone declines and facial fat stores are depleted, acne scars typically become more noticeable. Current treatments for acne scarring include dermabrasion, laser resurfacing, surgical excision, and certain temporary fillers.