Global biotech company committed to delivering transformative therapies to patients with orphan dermatologic and other underserved conditions, Castle Creek Pharmaceuticals confirmed manifesting the assessment of a Phase 2 study of diacerein 1% ointment (CCP-020) for the treatment of Epidermolysis Bullosa Simplex (EBS) validate for the first disease-specific Investigator’s Global Assessment (IGA) scale.
EBS is a seldom dermatologic condition where patients mostly children are afflicted with a genetic defect wherein the structural integrity of the natural skin is dwindled thus hindering natural hydration and recovery leading to frequent blistering and rendering it fragile.The previous Phase 2 study of CCP-020 used blister count reduction as the primary efficacy endpoint, due to the absence of an instrument for clinicians evaluating the effects of pharmacological interventions on overall disease severity for people living with EBS paving way for the recent development thus.
Greg Licholai, MD, president and chief medical officer at CCP. “As we work to support an underserved patient population, we have a responsibility to develop effective protocols that can be applied to current and future clinical studies, and we believe this new IGA scale is a tremendous step forward for EBS research.”
In a bid to testify new IGA scale, investigators evaluated blinded photographs of crippled body locations sought from patients during the Phase 2 study. The primary endpoint was the proportion of patients with moderate-to-severe lesions who achieved treatment success, defined as an IGA score of 0 or 1 on a 5-point scale at week 16 of treatment with at least a 2-point reduction in the IGA score compared to baseline.
CCP endeavors to further analyse the IGA Scale of the overall disease displaying moderate to severe EBS in the underway Phase 3 study that seeks to discern the efficacy of CCP-020.
Image Source- Castle Creek Pharmaceuticals