Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa

Stopped early · Phase 3

Conditions studied: Epidermolysis Bullosa

In brief

The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

Key facts

Study ID

NCT02670330

Run by

Scioderm, Inc.

People needed

152

Starts

2015-06-09

Expected to finish

2018-09-03

Last updated by the study team

2019-09-27

Who can join

Age: 0 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 was under the age of 18 but capable of providing assent, signed assent from the participant.
• Participant (or caretaker) must have been willing to comply with all protocol requirements.
• Participants who completed the SD-005 study (on study drug at Visit 5, approximately 90 days from baseline).

You may not qualify if…

• Participants who did not meet the entry criteria outlined above.
• Pregnancy or breastfeeding during the study. (A urine pregnancy test was performed at the final visit for Study SD-005 for female participants of childbearing potential and repeated at screening/baseline visit of Study SD-006 if these visits did not occur on the same day).
• Female participants of childbearing potential who were not abstinent or not practicing a medically acceptable method of contraception.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Redwood City, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Chicago, Illinois, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Columbia, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — East Setauket, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — San Antonio, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Kogarah, New South Wales, Australia
• Study site — Parkville, Victoria, Australia
• Study site — Salzburg, Austria
• Study site — Nice, France
• Study site — Paris, France
• Study site — Toulouse, France
• Study site — Freiburg im Breisgau, Germany
• Study site — Hanover, Germany
• Study site — Tel Aviv, Israel
• Study site — Kaunas, Lithuania

Full record on ClinicalTrials.gov

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