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Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

NCT02090283 ↗

Phase 2 Terminated 42 enrolled Scioderm, Inc. Amicus Therapeutics · collabFood and Drug Administration (FDA) · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to assess the continued safety of topical use of SD-101 cream (6%) in participants with Epidermolysis Bullosa (EB). Funding Source: FDA Office of Orphan Products Development

Timeline

Start
2014-03-26
Primary completion
2018-09-14
Completion
2018-09-14

Publications

  • Results Paller A., Browning J., Aslam R., et al. Efficacy and Safety Results From a 24-Month, Open-Label Extension of a Phase 2b Dose-Ranging Study of SD-101 Cream in Patients With Epidermolysis Bullosa. Abstract presented at European Academy of Dermatology and Venereology, 26th Congress, Geneva, Switzerland, September 13-17, 2017.

Drugs

EvaluationDrugModalityDoseRoute
Subject allantoin Small molecule 6 % Topical

Indications

epidermolysis bullosa