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
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