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New ointment could ease blistering in rare skin disease

NCT ID NCT06073132

Disease control Sponsor: TWi Biotechnology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests an ointment called diacerein 1% on people with a rare genetic skin condition (EBS) that causes fragile skin and painful blisters. About 80 participants will apply the ointment daily to see if it clears blisters and reduces pain. The trial is double-blind, meaning neither patients nor doctors know who gets the real ointment versus a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is at least 6 months old at Visit 2 (Day 1/Baseline A). 2. Patients has been clinically diagnosed with severe EBS or intermediate EBS, confirmed by documented genetic diagnosis to have autosomal dominant mutations in KRT5 or KRT14 gene. 3. Patient with ≥ 3% BSA of EBS lesions excluding palms and soles at Visit 2 (Day 1/Baseline A). 4. Patient's EBS lesions within the Treatment Area have an IGA score of ≥3 at Visit 2 (Day 1/Baseline A). 5. Patient/caregiver agrees to follow study medication application instructions. 6. Patient (and caregiver/legal guardian) agrees to report use of all prescription and over-the-counter medications, including topical therapies applied to the body, e.g., medical cleansers, bleach cleansers, bleach baths, topical antiseptics, topical disinfectants, etc. for the duration of the study. 7. Patient (and caregiver/legal guardian) is willing and able to comply with all study visits and all the protocol requirements, including completing questionnaires. 8. Patient (and caregiver/legal guardian) is able to provide written informed consent; assent based on age. 9. Female patient of childbearing potential must have a negative pregnancy test prior to randomization. 10. Female patient of childbearing potential is willing to practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of \< 1% per year) from Screening throughout the end of the study. Exclusion Criteria: 1. Patient has a clinically significant skin disease other than EBS (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or a vascular disorder associated with cutaneous erosions/ulcerations, that may confound assessments of efficacy or safety. 2. Patient has a clinically significant underlying medical condition, psychiatric condition (such as major depressive or psychotic disorder, severe intellectual disability, or alcohol or drug use disorder), or requires concomitant medication that based on the investigator's judgement may impair evaluation of the Treatment Area or exposes the patient to an unacceptable risk by study participation. 3. Patient has used any diacerein-containing product within 6 months prior to Visit 2 (Day 1/Baseline A). 4. Patient has had a cutaneous infection in the Treatment Area or use systemic antibiotics within 7 days prior to Visit 2 (Day 1/Baseline A). 5. Patient has uncontrolled diabetes mellitus (HbA1c ≥ 6.5%), hepatic enzyme abnormalities (alanine aminotransferase or aspartate aminotransferase \>2.5 the upper limit of normal (ULN), or total bilirubin \>2.0x ULN), or renal abnormalities (estimated glomerular filtration rate \[eGFR\]\< 30 ml/min/1.73 m2) during the Screening period. 6. Patient has a current malignancy, or a history of treatment for a malignancy within 5 years (with the exception of treated non-melanoma cutaneous malignancy e.g., surgically resected with clear margins) prior to Visit 2 (Day 1/Baseline A). 7. Patient is treated with protocol-excluded topical therapies other than steroids within 2 weeks prior to Visit 2 (Day 1/Baseline A) that might influence the assessment of the Treatment Area throughout the study period. 8. Patient has been treated with topical steroids on the EBS lesions within 2 weeks or systemic steroids within 4 weeks. prior to Visit 2 (Day 1/Baseline A). (Note: inhaled and ophthalmic products containing steroids are allowed.) 9. Patient has been treated with: (a) an approved biologic anti-inflammatory therapy (such as monoclonal antibodies that target to modulate the immune responses) and (b) other immunosuppressive/immunomodulatory therapies or chemotherapy within 8 weeks prior to Visit 2 (Day 1/Baseline A). 10. Patient has been treated with any investigational drug or device within 30 days or 5 half-lives, whichever is longer, prior to Visit 2 (Day 1/Baseline A). 11. Patient has a history of allergy or hypersensitivity to any component of study medications, including diacerein or rhein. 12. Patient is pregnant or breastfeeding/lactating. 13. Patient has a planned or anticipated major surgical procedure or other activity that would interfere with their ability to comply with protocol requirements.

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Conditions

The condition(s) this trial relates to.

epidermolysis bullosa simplex epidermolysis bullosa simplex 1B, generalized intermediate

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Generalized epidermolysis bullosa simplex

Contacts and locations

Locations

  • Asian Hospital

    City of Muntinlupa, Philippines

  • Children's Health Ireland

    Dublin, Ireland

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Cincinnati Childrens Hospital

    Cincinnati, Ohio, 45229, United States

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, China

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

    Milan, Italy

  • Gangnam Severane Hospital

    Seoul, South Korea

  • Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust - Somers Clinical Research Facility (CRF)

    London, United Kingdom

  • Health Cube Medical Clinics

    Mandaluyong, Philippines

  • Hospital Tunku Azizah (Hospital Wanita Dan Kanak-kanak Kuala Lumpur)

    Kuala Lumpur, Malaysia

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital of Skin and Venereal Diseases of Thessaloniki

    Thessaloniki, Greece

  • Iloilo Doctors Hospital

    Iloilo City, Philippines

  • Istituto Dermopatico dell'Immacolata (IDI) - Istituto di

    Rome, Italy

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mission dermatology Center

    Rancho Santa Margarita, California, 92688, United States

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • Northwestern University - Lurie Childrens's Hospital

    Chicago, Illinois, 60611, United States

  • OT.CO Clinic Osipowicz & Turkowski

    Warsaw, Poland

  • Postgraduate Institute of Medical Education and Research (PGIMER)

    Chandigarh, India

  • Premier Specialists

    Kogarah, Australia

  • Sheikh Khalifa Medical City (SKMC)

    Abu Dhabi, United Arab Emirates

  • Stanford University

    Stanford, California, 94304, United States

  • Sydney Children's Hospital

    Randwick, Australia

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • UOS "Centro delle Dermatosi Croniche Complesse e Genodermatosi" UOC Dermatologia

    Rome, Italy

  • UZ Leuven

    Leuven, Belgium

  • Universitaetsklinik fuer Dermatologie und Allergologie

    Salzburg, Austria

  • Università degli Studi di Modena e Reggio Emilia (UNIMORE)

    Modena, Italy