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

NCT02090283 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-11-04

Study results available
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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

Conditions

  • Epidermolysis Bullosa

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.

Sponsors & Collaborators

  • Amicus Therapeutics

    collaborator INDUSTRY

  • Food and Drug Administration (FDA)

    collaborator FED

  • Scioderm, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Amicus Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02090283 on ClinicalTrials.gov