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

• Status: Completed
• Trial end date: 2020-04-17
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the long term safety and tolerability of diacerein 1% ointment for 2 treatment cycles in subjects with EBS that previously participated in the CCP-020-301 or the CCP-020-101 studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Castle Creek Pharmaceuticals, LLC
• Treatments: Diacetylrhein

Criteria

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.