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Castle Creek begins enrollment in epidermolysis bullosa simplex treatment study
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Castle Creek Pharmaceuticals announced it has enrolled the first patient in its phase 2/3 clinical trial to measure safety and efficacy of CCP-020, diacerein 1% ointment, for treating epidermolysis bullosa simplex.
“Currently, there are no treatment options that target the underlying cause of [epidermolysis bullosa simplex (EBS)], the most common form of a family or rare conditions leading to extremely fragile skin,” researcher Amy Paller, MD, director of the Northwestern University Skin Disease Research Center, stated in the release. “The topical formulation of diacerein 1% that we are investigating is potentially disease-modifying, which would represent an important advance in treatment for patients.”
CCP-020’s properties block an inflammatory signaling pathway associated with EBS, which possibly strengthens epidermal tissue and supports healing. In a previous phase 2 trial of 17 patients with EBS, patients treated with CCP-020 showed an average of 60% reduction in blistering at 4 weeks, according to the release.
The randomized, double-blind phase 2/3 trial is planned to enroll 80 patietnts with a diagnosis of EPS at research sites in the United States, Europe, Israel and Australia. CCP-020 will be compared to control ointment for safety and efficacy when applied once-daily for 8 weeks.
Patients will use an electronic diary to report outcomes including pruritus, pain and mobility week-to-week, according to the release.
Reference: www.castlecreekpharma.com