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RECRUITING
NCT07482787
PHASE3

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

Sponsor: Paradigm Therapeutics

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

28 Days - 12 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-07-21

Completion Date

2027-06-17

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

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.

Locations (3)

Mission Dermatology

Rancho Santa Margarita, California, United States

Stanford University School of Medicine Dermatology Department

Redwood City, California, United States

Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

Charleston, South Carolina, United States