CLS001 topical gel vehicle

CLS001 topical gel vehicle is the inactive, aqueous-based gel formulation used as a control or placebo in clinical trials for CLS001 (omiganan pentahydrochloride). Developed by Maruho Co., Ltd. (following its acquisition of Cutanea Life Sciences), this vehicle is designed to be physically and chemically identical to the active CLS001 drug product but lacks the active pharmaceutical ingredient, the cationic antimicrobial peptide omiganan. It has been utilized in Phase 2 multicenter, randomized, double-blind studies to establish a baseline for safety and efficacy against which various concentrations of omiganan (1%, 1.75%, and 2.5%) were evaluated for the treatment of moderate to severe inflammatory acne vulgaris.