Trial Search Results
Study of Effectiveness and Safety of SD-101 in Subjects With Epidermolysis Bullosa
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.
Stanford is currently accepting patients for this trial.
- Drug: 3% SD-101 dermal cream
- Drug: 6% SD-101 dermal cream
- Drug: Vehicle (0% SD-101)
- 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
- 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.
Ages Eligible for Study
6 Months - N/A
Genders Eligible for Study