Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subj… (NCT03389308) | Clinical Trial Compass
CompletedPhase 2
Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
United States51 participantsStarted 2017-12-01
Plain-language 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.
Who can participate
Age range6 Months – 99 Years
SexALL
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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.