Castle Creek begins Phase II/III of topical diacerein to treat epidermolysis bullosa simplex
Castle Creek Pharmaceuticals LLC (Parsippany, N.J.) began the Phase II/III DELIVERS trial to evaluate topical 1% diacerein (AC-203, CCP-020) in about 80 patients ages ≥4 with epidermolysis bullosa simplex.
The double-blind, international trial will test topical diacerein once daily for 8 weeks against a placebo topical ointment. The primary endpoint is the proportion of patients who achieve an Investigator's Global Assessment (IGA) of grade 0 or 1 at week 16 with a ≥2-point reduction in IGA score. Secondary endpoints include safety, pruritus intensity, pain intensity and mobility questionnaires and reduction in body surface area (BSA) of lesions...
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