Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex

Key Inclusion Criteria

• The subject is capable of understanding and complying with protocol requirements.
• The subject or the subject's legally acceptable representative signs and dates a written, informed consent/assent form and any required privacy authorization prior to the initiation of any study procedures.
• Subject has a documented genetic mutation consistent with EBS.
• Subject has completed study CCP-020-301 or participated in study CCP-020-101.
• Subject/caregiver agrees to report use of any topical therapies applied to EBS lesions
• If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control, for the duration of the study.
• Subject is non-lactating and is not planning for pregnancy during the study period.
• Subject is willing and able to follow all study instructions and to attend all study visits.

Key Exclusion Criteria

• Subject has EBS lesions to be treated that are infected
• Subject has evidence of a systemic infection or has used systemic antibiotics within 7 days prior to Baseline Visit.
• The subject was discontinued from the feeder study due to an adverse event judged to be related or possibly related to the study medication.
• Subject has experienced a change in clinical status from the feeder study that puts the subject at undue risk to participate.