Trial
NCT02090283
Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
Phase IITERMINATEDREGULATORYConfidence: HIGH
Sponsor
Scioderm, Inc.
Collaborators
Amicus Therapeutics; Food and Drug Administration (FDA)
Condition
Epidermolysis Bullosa
Intervention
SD-101 dermal cream (6%)
Why stopped
The Sponsor voluntarily recalled SD-101 and terminated the study due to GMP deficiencies identified during an FDA inspection at the site of the manufacturer.
Provenance
Dataset: 2026-07-02 • Source: ClinicalTrials.gov API v2 • Last update: 2019-11-04