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Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS)

NCT03154333 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-11-05

Study results available
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Summary

Epidermolysis bullosa simplex (EBS) is a rare genetic skin disease characterized by fragility of the skin and mucous membranes resulting in painful blisters and erosions after minor trauma. The purpose of this study is to compare the efficacy of diacerein 1% ointment to vehicle ointment when applied once-daily for 8 weeks in subjects with EBS.

Conditions

  • Epidermolysis Bullosa Simplex

Interventions

DRUG

diacerein 1% ointment

diacerein 1% ointment administered topically

DRUG

A placebo ointment

vehicle ointment administered topically

Sponsors & Collaborators

  • Castle Creek Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Mary Spellman, MD · Castle Creek Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-10-15
Completion
2018-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • France
  • Germany
  • Israel
  • Netherlands
  • 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 NCT03154333 on ClinicalTrials.gov