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 subject or the subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject.
- - Subject (or caretaker) must be willing to comply with all protocol requirements.
- - Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.
- - Subjects must be 6 months of age and older.
- - Subjects must have 1 target wound within a prespecified size range at study entry
- - Target wound must be of at least a certain age
- - Subjects who do not meet the entry criteria outlined in inclusion criteria.
- - Selected target wound cannot have clinical evidence of local infection.
- - Use of any investigational drug within the 30 days before enrollment.
- - Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
- - Use of systemic or topical steroidal therapy within the 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids are allowed).
- - Use of systemic antibiotics within the 7 days before enrollment.
- - Current or former malignancy.
- - Arterial or venous disorder resulting in ulcerated lesions.
- - Diabetes mellitus.
- - Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed ar screening for female subjects of childbearing potential)
- - Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception.
- - Known history of cardiac, hepatic, or renal disease.
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