Epidermolysis Bullosa Simplex
Conditions
Interventions
Subjects who are enrolled will apply diacerein 1% ointment daily for 8 weeks in
a 16 week cycle.
Sponsors
Medpace
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements., 2. The subject or, when applicable, 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., 3. Subject has a documented genetic mutation consistent with EBS. , 4. Subjects who participated in the CCP-020-301 or the CCP-020-101 study are eligible to be rolled into the CCP-020-302 open label extension study, regardless of their completion status on the feeder study. , 5. Subject/caregiver agrees to report use of any topical therapies applied to EBS lesions (e.g. medicated cleansers, bleach cleansers, bleach baths, topical antiseptics, topical disinfectants, etc.)., 6. 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, as defined by this protocol, for the duration of the study., 7. Subject is non-lactating and is not planning for pregnancy during the study period., 8. Subject is willing and able to follow all study instructions and to attend all study visits.
Exclusion criteria
Exclusion criteria: 1. Subject has EBS lesions to be treated that are infected (i.e., EBS lesions that require topical antibiotic therapy to treat an infection)., 2. Subject has evidence of a systemic infection or has used systemic antibiotics within 7 days prior to Baseline., 3. The subject was discontinued from the feeder study due to an adverse event judged to be related or possibly related to the study medication., 4. Subject has experienced a change in clinical status from the feeder study that, in the investigator's opinion, puts the subject at undue risk to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be evaluated in terms of the occurrence of AEs and changes in clinical laboratory parameters, clinical examination findings, vital signs, weight, and urine measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed