NCT07482787

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

A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Paradigm Therapeutics · Industry
• Sex: All
• Age: 28 Days – 12 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, study to compare the efficacy and safety of SD-101-6.0 cream vs. placebo (SD 101-0.0) on wounds in patients with Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) EB. SD-101-6.0 cream or placebo (SD-101-0.0) will be applied topically, once a day to the entire body for a period of 60 days. Enrolled patients will have 1 target wound selected at baseline. The selected target wound must be at least 21 days old (size 10 to 50 cm2). Photographic confirmation of the target wound location will be collected at baseline, and the picture saved from the first visit will be used to confirm location of the target wound at subsequent visits. The patient will return to the study site for Visit 2 (14 days ±7 days from baseline), Visit 3 (30 days ±7 days from baseline), and Visit 4 (60 days ±7 days from baseline) to have the target wound re-assessed for the level of healing. Once the target wound is healed, it will be considered healed at subsequent visits and no further re-assessment of the target wound will be conducted The ARANZ SilhouetteStar™ will be used to measure the target wound at all visits until the target wound is documented as closed. Assessment of itching will be evaluated at each visit. In addition, body surface area (BSA), and other secondary endpoints will be evaluated at the baseline and Month 2 visits.

Conditions

• Epidermolysis Bullosa (EB)

Interventions

Type	Name	Description
DRUG	SD-101 Dermal Cream (6%)	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.
DRUG	Vehicle (SD-101 0%)	A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.

Timeline

• Start date: 2026-05-15
• Primary completion: 2027-05-17
• Completion: 2027-06-17
• First posted: 2026-03-19
• Last updated: 2026-03-20

Regulatory

• FDA-regulated drug study