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)

Castle Creek Pharmaceuticals, LLC0 个研究点目标入组 80 人开始时间: 2018年2月21日最近更新: 2020年8月31日

研究概览

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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. Subject has completed study CCP-020-301 or participated in study CCP-020-101.
•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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 44
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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.

发起方

Castle Creek Pharmaceuticals, LLC