The EBShield Study for Epidermolysis Bullosa Simplex

The EBShield study is an international, multicenter, randomized, double-blind, parallel group, vehicle-controlled, Phase 2/3 study with open-label extension to evaluate the efficacy and safety of diacerein 1% ointment (AC-203) for the treatment of severe and intermediate epidermolysis bullosa simplex (EBS). The EBShield study is an international clinical trial with global research sites*. Participants will be randomized in a double-blind design to receive the active drug or vehicle for 8 weeks. Then, after completion of the 8-week follow-up period, all participants will continue to receive the active drug for 24 weeks. Participants will have the ointment applied once daily, assist in keeping a patient diary, rate pain and pruritus, and fill in questionnaire of the Quality of Life in Epidermolysis Bullosa .

* USA, Taiwan, Australia, Philippines, UK, Italy, Austria, Poland, Malaysia, and more countries to join.