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

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Trial ID: NCT02014376

Purpose

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).

Official Title

A Phase 2b, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Effectiveness and Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa

Eligibility


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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.

Intervention(s):

drug: SD-101 dermal cream (3%)

drug: SD-101 Dermal Cream (6%)

drug: Vehicle (SD-101 0%)

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Emily Gorell
650-721-7166