[Source: PipelineReview.com] – Capstone Therapeutics (Nasdaq:CAPS – News) announced today the completion of enrollment for the first of its two ongoing AZX100 Phase 2 pilot clinical trials in keloid scarring.
These Phase 2 pilot trials are blinded, placebo controlled, multicenter, parallel group dose ranging studies to evaluate the safety and preliminary efficacy of AZX100 following excision of keloid scars. The primary objective of the studies is to evaluate the efficacy of AZX100 based on the differences among dosage groups in Patient and Observer Scar Assessment Scale (POSAS) scores at 12 months. Secondary objectives include safety determination and evaluations of efficacy via validated scar assessment scales using both 2D and 3D digital photography. The original clinical trial plan specified thirty subjects for enrollment in a single AZX100 pilot keloid study. Based on recruitment success, sixty subjects have now been enrolled in the first clinical trial, and an additional sixty subjects are being recruited for the second keloid trial. Collectively, these studies will evaluate AZX100 versus placebo in up to 120 subjects across a range of four active dose groups in the prevention or reduction of keloid scars.