Study of Effectiveness and Safety of SD-101 in Subjects With Epidermolysis Bullosa
Trial ID or NCT#
The purpose of this study is to assess whether SD-101 cream (3% or 6%) is effective in treating the lesions in subjects with Simplex, Recessive Dystrophic, or Junctional Epidermolysis Bullosa.
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
- - 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.
- - 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.
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