Status:
COMPLETED
Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
Lead Sponsor:
Castle Creek Pharmaceuticals, LLC
Conditions:
Epidermolysis Bullosa
Epidermolysis Bullosa Simplex
Eligibility:
All Genders
6-99 years
Phase:
PHASE2
Brief 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-02...
Detailed Description
This is an international, multicenter, open-label, long term extension study evaluating the safety of topical Diacerein 1% Ointment for the treatment of subjects with EBS. At Visit 1, EBS subjects who...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2020
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03389308
Start Date
December 1 2017
End Date
April 17 2020
Last Update
September 16 2020
Active Locations (3)
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1
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina, United States, 27516
3
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78218