Dermata Therapeutics, LLC completed enrollment of patients in its Phase 2b clinical trial evaluating the safety, tolerability and efficacy of DMT310 in moderate to severe acne patients.
The Phase 2b trial enrolled 182 patients randomly in two groups, DMT310 or placebo, at 14 sites across the United States.
"Today's completion of enrollment marks a significant milestone for Dermata and our DMT310 program as we advance this unique product for the treatment of acne," states Christopher Nardo, PhD., Dermata's SVP, Development, in a news release. "DMT310 offers a new approach to the treatment of acne with its once-weekly application and combination of mechanical and biological mechanisms of actions that is 100% natural. We are very pleased with the positive feedback we have received from both physicians and patients, and we look forward to top-line results in June 2020."
DMT310-003 Trial Design
DMT310-003, is a 12-week, multi-center, double-blind, randomized, placebo-controlled trial designed to evaluate the safety, tolerability and efficacy of once-weekly dosing of DMT310 in 182 moderate-to-severe acne patients, defined as a grade 3 or 4 on the Investigator Global Assessment (IGA) five-point scale with at least 20 inflammatory and 20 non-inflammatory lesions on the face. The trial contained two arms: (1) DMT310 + H2O2; and (2) Placebo + H2O2. The primary endpoint is the absolute change from baseline in inflammatory lesion count at week 12. The secondary endpoints are absolute change from baseline in non-inflammatory lesion count and the IGA treatment success at week 12, defined as percentage of patients with at a two-point reduction on IGA compared to baseline. The trial also uses a HIPAA compliant smartphone application on patients' mobile devices to document treatment compliance. During the study, patients will record a10-second video, which is then reviewed by clinic staff, to ensure complete and timely application of the product.
DMT310 is a natural product derived from a rare variant of freshwater sponge that is harvested under specific environmental conditions and then processed into a powdered. The powder is mixed with hydrogen peroxide immediately prior to application and only needs to be applied once per week. The product's multiple mechanisms of action can treat the several clinical and aesthetic skin conditions.