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Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
Not Recruiting
Trial ID: NCT03389308
Purpose
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.
Official Title
An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex (EBS)
Stanford Investigator(s)
Joyce Teng, MD, PhD
Professor of Dermatology and, by courtesy, of Pediatrics
Eligibility
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.
Intervention(s):
drug: Diacerein 1% Ointment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elidia V Tafoya
6507241982