MedTrace Logo

ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

NCT02384460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2020-04-09

Study results available
· View outcomes & findings →

Summary

The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding Source - United States Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).

Conditions

  • Epidermolysis Bullosa

Interventions

DRUG

SD-101-6.0 cream

applied topically once a day for 90 days

DRUG

Placebo (SD-101-0.0) cream

applied topically once a day for 90 days

Sponsors & Collaborators

  • Amicus Therapeutics

    collaborator INDUSTRY

  • Scioderm, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Amicus Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-11
Primary Completion
2017-07-05
Completion
2017-07-05

Countries

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

Study Locations

More Related Trials

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 NCT02384460 on ClinicalTrials.gov