A Multi-center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein after Maximum Use, Topical Administration of CCP-020 (Diacerein 1% ointment) to Patients with Epidermolysis Bullosa (EB)

Castle Creek Pharmaceuticals, LLC0 个研究点目标入组 20 人开始时间: 2018年9月27日最近更新: 2018年10月1日

试验速览

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•1. Subject/caregiver is able to comprehend and willing to sign an Informed Consent and/or Assent Form.
•2. Subject has a documented genetic mutation consistent with EB.
•3. Subject has EB lesions on = 2% body surface area (BSA) and the EB lesions are in the following body areas:
•4. Subject/caregiver agrees to not apply any other topical products to the application area during the treatment period
•5. Subject is non-pregnant, non-lactating and is not planning for pregnancy during the study period
•6. Subject is in good general health and free of any known disease state or physical condition which, in the investigator’s opinion, which exposes the subject to an unacceptable risk by study participation.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 15
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Subject has EB lesions where drug will be applied that are infected (i.e., EB lesions that require anti-microbial therapy to treat an infection)
•2. Subject has an active non-EB skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn) that, in the opinion of the investigator, would put the subject at undue risk by study participation or would interfere with the study medication application or the study assessments
•3. Subject has a history of sensitivity to any of the ingredients in the study medication
•4. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to dosing

发起方

Castle Creek Pharmaceuticals, LLC