The initiation of this clinical trial marks another milestone in Dermata's strategy by adding a second product to its Tome skincare portfolio, targeting significant opportunities in the consumer skincare market. Acne affects approximately 50 million Americans annually, representing a substantial market for accessible, effective, and convenient treatment options. Tome Clearing Treatment kits salicylic acid, an FDA-recognized over-the-counter ("OTC") acne active ingredient, with Dermata's Bioneedle™ powder in a differentiated once-weekly treatment regimen. The study is designed to evaluate improvements in acne lesions and post-inflammatory hyperpigmentation, with the goal of generating clinical evidence to support the product's planned commercialization.
Tome Clearing Treatment Clinical Trial Design
The clinical trial is expected to enroll approximately 24 participants with facial acne vulgaris in an open-label study. Participants will topically apply Tome Clearing Treatment once weekly for 12 weeks. A dermatologist will evaluate participants on endpoints including change from baseline in inflammatory and noninflammatory lesion counts, Investigator Global Assessment ("IGA") treatment response, and improvement in post-inflammatory hyperpigmentation. IGA is measured on a five-point scale from 0 to 4, with treatment response defined as at least a one-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Participants may elect to continue treatment for an additional 12 weeks, which will help provide the Company with additional data regarding the safety and efficacy of Tome Clearing Treatment over an extended treatment period. The clinical data generated from this trial will help support marketing and commercialization of Tome Clearing Treatment.