RECRUITING Phase 3 ClinicalTrials.gov

Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

Sponsor: Paradigm Therapeutics • ClinicalTrials.gov ID: NCT07482787

Registry updated: 2026-10-15

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Description

The upcoming trial is for EB patients is a topically applied whole-body treatment of patients with either Simplex, RDEB or Junctional (nH) ages 1 month to 12 years old at study entry. There are only 4 site visits by patients with minimal assessments over a 2-month period, and patients completing this study will have the ability to continue receiving SD-101-6.0 at home in an open-label extension study. The drug product and placebo require no special preparation or storage conditions (room temperature).

Interventions

SD-101 Dermal Cream (6%) (Drug)
SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
Vehicle (SD-101 0%) (Drug)
A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.

Eligibility criteria

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.

Conditions

Epidermolysis Bullosa (EB)

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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