Devonian Health Group to Test Botanical Dermatitis Treatment in Children

The trial will evaluate the efficacy and safety of two concentrations of Thykamine™—0.05% and 0.1%—against a placebo over a 12-week period. Designed as a seamless adaptive study, it will enroll 306 participants, starting with 102 patients in the Phase II portion before transitioning to a confirmatory Phase III. Dr. Charles Lynde, a prominent dermatologist and director of the Lynde Institute for Dermatology, will serve as the principal investigator, leading a network of specialized research centers.

An independent Data Safety Monitoring Committee will oversee the process, conducting unblinded reviews of adverse events and managing sequential enrollment. The study will first focus on children aged two to 17, with the cohort of infants aged three months to two years beginning only after rigorous safety checks. The primary success metric is defined as achieving a clear or almost clear score on the validated Investigator's Global Assessment for Atopic Dermatitis scale by the end of the 12-week treatment cycle. This development follows positive results from the company's previous adult clinical trials, where the botanical therapy demonstrated both safety and significant clinical efficacy.