About the DELIVERS Study
The DELIVERS study is evaluating the safety and efficacy of diacerein 1% ointment (CCP-020) for the treatment of epidermolysis bullosa simplex (EBS).
What is CCP-020?
CCP-020 is an investigational topical diacerein 1% ointment being developed by Castle Creek Pharmaceuticals. It is a potentially disease-modifying therapy that may block an important inflammatory signaling pathway associated with EBS, which could strengthen epidermal tissue and support healing. Previously, oral forms of diacerein has been studied for the treatment of joint diseases such as osteoarthritis and other conditions including eczema, rash, and pruritus.
The DELIVERS study is an international clinical trial, with clinical research sites in the US, Europe, Israel and Australia. Participants will be randomized in a double-blind design, in one of two parallel-groups in this Phase II clinical trial. Researchers will compare the efficacy of diacerein 1% ointment (CCP-020) to a control ointment when applied once-daily for eight weeks in people living with EBS. Randomization will be stratified by genotype and age group. Participants will report outcomes including pruritus, pain, and mobility week-to-week via an electronic diary (eDiary). Follow-up visits will continue for a maximum of 22 weeks.
The DELIVERS study will include about 80 participants who have a clinical and laboratory confirmed diagnosis of EBS. Participants must be at least four years of age with lesions that are not infected, and treatable based on certain predetermined criteria. Potential candidates for participation in this trial should not have another immediate family member participating also.