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

Stopped early · Phase 2

Conditions studied: Epidermolysis Bullosa

In brief

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

Key facts

Study ID

NCT02090283

Run by

Scioderm, Inc.

People needed

42

Starts

2014-03-26

Expected to finish

2018-09-14

Last updated by the study team

2019-11-04

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Palo Alto, California, United States
• Study site — Chicago, Illinois, United States
• Study site — St Louis, Missouri, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — San Antonio, Texas, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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