Castle Creek Pharmaceuticals’ Phase 2 Study of Diacerein 1% Ointment (CCP-020) for EBS

DELIVERS EBS logo

A Letter to the Patients from Castle Creek Pharmaceuticals
We are grateful to the patients and families who participated in Castle Creek Pharma’s DELIVERS study, which evaluated the safety and efficacy of diacerein 1% ointment (CCP-020) for the treatment of Epidermolysis Bullosa Simplex (EBS). Because the Independent Data Monitoring Committee (IDMC) has indicated that the DELIVERS study, as currently designed, is unlikely to meet statistical objectives, Castle Creek has decided to discontinue the DELIVERS study.

As a next step, we plan to begin discussions with the FDA about a potential new clinical trial with an expanded number of participants.

Important: The current study results support the safety profile of CCP-020, and patients who are currently participating in the DELIVERS study will have the option of entering an open-label safety extension trial. The results of this analysis will not impact other ongoing clinical studies for CCP-020.

Castle Creek Pharma is dedicated to delivering transformative therapies to patients with orphan dermatologic and other underserved conditions and we remain committed to those living with Epidermolysis Bullosa.


The DELIVERS study is evaluating the safety and efficacy of diacerein 1% ointment (CCP-020) for the treatment of epidermolysis bullosa simplex (EBS).

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.

The DELIVERS study is an International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex (EBS)

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. Participants will also report outcomes including pruritus, pain, and mobility. Follow-up visits will continue for a maximum of 22 weeks. Patients who complete the study may be eligible to enroll in a separate open-label extension study, where all participants will receive diacerein 1% ointment for 2 additional treatment cycles.

The DELIVERS study has been open since June 2017, but additional research sites have been added throughout the world over the last several months. The study is currently being conducted at about 20 locations throughout the United States, Europe, Israel and Australia. The sponsor has a travel vendor in place to assist with making travel arrangements and costs for such arrangements will be covered by the study.

For more information about the DELIVERS study including a list of participating centers and their contact information, you can visit www.deliversebs.com or  https://clinicaltrials.gov/ct2/show/study/NCT03154333