Epidermolysis Bullosa Clinical Trial
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)
Verified date | August 2020 |
Source | Castle Creek Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | April 17, 2020 |
Est. primary completion date | April 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 99 Years |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina (UNC) - Chapel Hill | Chapel Hill | North Carolina |
United States | Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | Children's Hospital of San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Castle Creek Pharmaceuticals, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment-emergent Adverse Events | Number and percentage of participants with any treatment-emergent adverse event. | up to 52 weeks |
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