Trial Search Results
Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
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.
Stanford is currently not accepting patients for this trial.
Castle Creek Pharmaceuticals, LLC
- Drug: diacerein 1% ointment
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
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.
Ages Eligible for Study
6 Months - 99 Years
Genders Eligible for Study