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.

Lead Sponsor:

Scioderm, Inc.


  • Drug: 3% SD-101 dermal cream
  • Drug: 6% SD-101 dermal cream
  • Drug: Vehicle (0% SD-101)


Phase 2


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Emily Gorell