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) - CCP-020-302

Medpace0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月15日

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•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.

•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.

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