Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06073132
The ClinicalTrials.gov registry entry for NCT06073132 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TWi Biotechnology, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06073132 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06073132?
The interventions under investigation include: AC-203 (DRUG), Vehicle (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06073132?
This trial is sponsored by TWi Biotechnology, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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