Topical SD-101-6.0 cream for epidermolysis bullosa in children (1 month to 12 years)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study compares SD-101-6.0 cream with a placebo in children and young patients with simplex EB, recessive dystrophic EB, or junctional non-Herlitz EB. One target wound per participant (10–50 cm2, at least 21 days old) will be monitored for healing over 60 days, using standardized wound measurements and itching assessments. Participants will have four study visits over about two months, with an optional open-label extension allowing home use of SD-101-6.0 after the trial. The product and placebo require no special storage and the overall design emphasizes safety and wound-healing efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Informed Consent (ICF) form signed by the patient or patient's legal representative. Since all patients with be 12 years old or younger at study entry, signed assent from the patient's legal representative will be required.
2. Patient (or caretaker) must be willing to comply with all protocol requirements.
3. Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH (intermediate) EB.
4. Patient must have 1 target wound (size 10 to 50 cm2).
5. Patients must be between 28 days to 12 years at study entry
6. Target wound must be present for 21 days or more.
7. Patients must have wound burden based on BSA of ≥5% at baseline

Exclusion Criteria:

1. Patients who do not meet the entry criteria outlined above.
2. Selected target wound cannot have clinical evidence of local infection.
3. Use of any investigational drug or approved EB therapy within 30 days before enrollment.
4. Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.
5. Use of systemic or topical steroidal therapy within 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids are allowed)
6. Use of systemic antibiotics within 7 days before enrollment.
7. Current or former malignancy.
8. Participant is one of the following:

   1. Not of childbearing potential (premenarchal or male/not in possession of a uterus).
   2. If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control:

      * Abstinence from heterosexual intercourse as a lifestyle choice.
      * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before product administration.
      * Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.

Where it's running

• Mission Dermatology
  Rancho Santa Margarita, California, United States Recruiting
• Stanford University School of Medicine Dermatology Department
  Redwood City, California, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
  Charleston, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Kathleen Watts
• Email: Cure@Kapadi.com
• Phone: 352-586-4083

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.