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NCT06073132 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Generalized Epidermolysis Bullosa Simplex, sponsored by TWi Biotechnology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT06073132: Recruiting Phase 2 study of Generalized Epidermolysis Bullosa Simplex, sponsored by TWi Biotechnology.
NCT06073132 is a Phase 2 study of Generalized Epidermolysis Bullosa Simplex that is actively recruiting participants, run by TWi Biotechnology. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06073132, a Phase 2 study of Generalized Epidermolysis Bullosa Simplex, is actively recruiting participants, sponsored by TWi Biotechnology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The static IGA is the investigator's visual clinical assessment of the average overall intensity of lesions in the designated Treatment Area at a particular time point. EBS-IGA is a 5-point scale is a 5-point scale (clear=0; almost clear=1; mild=2; moderate=3; severe=4)
Conditions Studied
Interventions
- DRUG AC-203
- DRUG Vehicle
Study Locations (20)
Other
- Premier Specialists - Kogarah
- Sydney Children's Hospital - Randwick
- Universitaetsklinik fuer Dermatologie und Allergologie - Salzburg
- UZ Leuven - Leuven
- Hopital Necker-Enfants Malades - Paris
- Andreas Syggros Hospital 1st University Clinic of Skin and Venereal Diseases of Athens - Athens
- Hospital of Skin and Venereal Diseases of Thessaloniki - Thessaloniki
- Postgraduate Institute of Medical Education and Research (PGIMER) - Chandigarh
- Children's Health Ireland - Dublin
- Tel Aviv Sourasky Medical Center - Tel Aviv
California
- Mission dermatology Center - Rancho Santa Margarita
- Stanford University - Stanford
Colorado
- Children's Hospital Colorado - Aurora
Florida
- Pediatric Skin Research, LLC - Miami
Illinois
- Northwestern University - Lurie Childrens's Hospital - Chicago
New York
- Stony Brook Dermatology - Stony Brook
Ohio
- Cincinnati Childrens Hospital - Cincinnati
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT06073132 shows while recruiting
NCT06073132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Generalized Epidermolysis Bullosa Simplex appearing as the primary indexed condition, and to 2 interventions - of which AC-203 is the first listed.
NCT06073132 names 20 study sites across 10 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06073132 about?
NCT06073132 is a clinical study titled "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)". 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.
What is the current status of trial NCT06073132?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-04-04. Estimated completion is 2027-01.
What conditions does trial NCT06073132 study?
This clinical trial studies the following conditions: Generalized Epidermolysis Bullosa Simplex.
What interventions are being tested in trial NCT06073132?
The interventions under investigation include: AC-203 (DRUG), Vehicle (DRUG).
Who is sponsoring clinical trial NCT06073132?
This trial is sponsored by TWi Biotechnology, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06073132 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06073132's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,118 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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