An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.

Phase 1

• Conditions: Epidermolysis Bullosa; 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: EUCTR2014-005679-96-LT
• Lead Sponsor: Scioderm, INC, An Amicus Therapeutics Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-09
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Informed Consent form signed by the patient or patient's legal
representative; if the patient is under the age of 18 but
capable of providing assent, signed assent from the patient.
2. Patient (or caretaker) must be willing to comply with all protocol
requirements.
3. Patient who completed the SD-005 study (on study drug at Visit 5)
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who do not meet the entry criteria outlined in the Inclusion criteria.
2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-005 for female patients of childbearing potential and repeated at Visit 1 if these visits do not occur on the same day)
3. Females of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified