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Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
Recruiting
I'm InterestedTrial 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%)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Emily Gorell
650-721-7166