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NOT YET 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

2026-05-15

Completion Date

2027-06-17

Last Updated

2026-03-20

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.