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

Trial ID or NCT#

NCT03389308

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: 6 Months to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
View All Criteria
Show Less

Investigator(s)

Joyce Teng, MD, PhD
Joyce Teng, MD, PhD
Dermatologist, Pediatric dermatologist
Professor of Dermatology and, by courtesy, of Pediatrics

Contact us to find out if this trial is right for you.

Contact

Elidia V Tafoya
6507241982

View on ClinicalTrials.gov