MedTrace Logo

An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)

NCT06073132 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-24

No results posted yet for this study

Summary

The proposed Phase 2/3 trial with double-blind and open-label extension phases is an international, multicenter study designed to assess the efficacy and safety of diacerein 1% ointment in patients with generalized EBS.

Conditions

  • Generalized Epidermolysis Bullosa Simplex

Interventions

DRUG

AC-203

The investigational product is formulated as 1% topical ointment

DRUG

Vehicle

Vehicle-only control study medication is the same formulation as investigational product without active ingredient

Sponsors & Collaborators

  • TWi Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2026-09-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • China
  • Greece
  • India
  • Ireland
  • Israel
  • Italy
  • Malaysia
  • Philippines
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Arab Emirates
  • 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 NCT06073132 on ClinicalTrials.gov