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Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa

NCT02670330 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2019-09-27

Study results available
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Summary

The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

Conditions

  • Epidermolysis Bullosa

Interventions

DRUG

SD-101-6.0 cream

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

  • Scioderm, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Amicus Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-09
Primary Completion
2018-09-03
Completion
2018-09-03

Countries

  • United States
  • Australia
  • Austria
  • France
  • Germany
  • Israel
  • Lithuania
  • Netherlands
  • Poland
  • Serbia
  • Spain
  • United Kingdom

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 NCT02670330 on ClinicalTrials.gov