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Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa

NCT02014376 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-01-13

Study results available
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Summary

The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).

Conditions

  • Epidermolysis Bullosa

Interventions

DRUG

SD-101 dermal cream (3%)

SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-3.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 3% and other excipients.

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.

Sponsors & Collaborators

  • Amicus Therapeutics

    collaborator INDUSTRY

  • Scioderm, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Amicus Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-06
Primary Completion
2014-06-24
Completion
2014-06-24

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 NCT02014376 on ClinicalTrials.gov