Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa

Completed · Phase 2 · Has a placebo group

Conditions studied: Epidermolysis Bullosa

In brief

The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).

Key facts

Study ID

NCT02014376

Run by

Scioderm, Inc.

People needed

48

Starts

2014-01-06

Expected to finish

2014-06-24

Last updated by the study team

2020-01-13

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 the participant's legal representative; if the participant is under the age of majority but capable of providing assent, signed assent from the participant.
• Participant (or caretaker) was willing to comply with all protocol requirements.
• Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.
• Participants 6 months of age and older.
• Participants had 1 target wound within a prespecified size range at study entry.
• Target wound was at least 21 days or older.

You may not qualify if…

• Participants who did not meet all the entry criteria outlined in inclusion criteria.
• Selected target wound had clinical evidence of local infection.
• Use of any investigational drug within 30 days before enrollment.
• Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.
• Use of systemic or topical steroidal therapy within 30 days before enrollment (inhaled steroids and ophthalmic drops containing steroids were allowed).
• Use of systemic antibiotics within 7 days before enrollment.
• Current or former malignancy.
• Arterial or venous disorder resulting in ulcerated wounds.
• Diabetes mellitus.
• Pregnancy or breastfeeding during the study (a urine pregnancy test was performed at screening for female participants of childbearing potential).
• Females of childbearing potential who were not abstinent and not practicing a medically acceptable method of contraception.
• Known history of cardiac, hepatic, or renal disease.

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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