A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB)

Phase 1

Conditions: Epidermolysis Bullosa (EB)
MedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2018-000439-29-NL

Lead Sponsor: Castle Creek Pharmaceuticals, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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