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23.08.2017

Castle Creek Enrolling EB Simplex Patients in DELIVERS Study of Diacerein 1% Ointment (CCP-020)

Castle Creek Pharmaceuticals is now enrolling patients in the Phase 2 DELIVERS study evaluating the safety and efficacy of diacerein 1% ointment (CCP-020) for the treatment of epidermolysis bullosa simplex.

Diacerein 1% ointment (CCP-020) is a potentially disease-modifying therapy that may block an important inflammatory signaling pathway associated with EB simplex, which could strengthen epidermal tissue and support healing. In a previously completed Phase 2 clinical trial that included 17 patients with EB simplex, patients treated with diacerein 1% ointment (CCP-020) showed an average 60 percent reduction in blistering after four weeks. Oral forms of diacerein have also been studied for the treatment of joint diseases such as osteoarthritis and other conditions including eczema, rash, and pruritus.

Participants in the DELIVERS study will be randomized in a double-blind design, in one of two parallel-groups. 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 EB simplex. 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 is an international clinical trial, with research sites in the US, Europe, Israel and Australia. It will include about 80 participants who have a clinical and laboratory confirmed diagnosis of EB simplex. Participants must be at least four years of age with lesions that are not infected, and treatable based on certain predetermined criteria. For more information and to find a study location, visit http://deliversebs.com

Panagiotis Zografos, Director, Medical Affairs, Castle Creek Pharmaceuticals

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DEBRA International provides information and news that may be of interest to people with EB, but does not recommend or endorse products, or participation in any particular clinical trial. We strongly recommend that anyone considering a treatment or clinical trial should also speak with their doctor, or medical team, who helps them manage their EB.