The protocol was submitted to the FDA under the agency’s special protocol assessment (SPA) regulations. The SPA process allows for FDA evaluation of trial protocol that will form the basis of an efficacy claim for a marketing application, and provides an agreement that the study design is acceptable to the FDA.
“We are eager to begin the Isolagen Therapy registration trials for the treatment of wrinkles and plan to begin enrolling patients as soon as possible,” said Nicholas Teti, Isolagen chairman and CEO.
The phase III trials will evaluate the efficacy and safety of Isolagen Therapy against placebo for the treatment of nasolabial skin fold wrinkles. Each trial will include 200 patients.