Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

• Status: Terminated
• Trial end date: 2018-09-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the continued safety of topical use of SD-101 cream (6%) in participants with Epidermolysis Bullosa (EB).

Funding Source: FDA Office of Orphan Products Development

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scioderm, Inc.
• Collaborators: Amicus Therapeutics; Food and Drug Administration (FDA)

Criteria

Inclusion Criteria:

• Informed consent form signed by the participant or participant's legal representative; if the participant is under the age of 18 but capable of providing assent, signed assent from the participant.

• Participant (or caretaker) must be willing to comply with all protocol requirements.

• Participant must have successfully completed the SD-003 study.

Exclusion Criteria:

• Participants who do not meet the inclusion criteria.

• Pregnancy or breastfeeding during the study. A urine pregnancy test will be performed at the final visit for SD-003 for female participants of childbearing potential.

• Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception.