Topical TCP-25 gel to help heal wounds in epidermolysis bullosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, double-blind, randomized, vehicle-controlled study uses intrasubject randomization where paired index wounds on the same patient are randomized to receive TCP-25 gel or matching vehicle. Treatment is applied over a 56-day period with clinic visits at baseline and every two weeks through Day 56, and a safety follow-up conducted by telephone or video about two weeks after the last dose. Wound healing is measured by trained clinicians using 3D digital photography and specialized software for wound area quantification, alongside safety, tolerability, and pharmacokinetic assessments. The trial initially enrolls patients 12 years and older with genetically or biopsy-confirmed dystrophic or junctional EB, with enrollment of 4–11 year olds planned after a safety review.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or by a skin biopsy with immunofluorescence mapping.
* Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use.

Exclusion Criteria:

* The patient has any subtype of EB other than DEB or JEB.
* The patient is currently being treated or planned to be treated with systemic antibiotics.

Note: Use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited.

• Use of systemic corticosteroids \>0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit.

Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.

• The patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Hopital St Louis
  Paris, France Recruiting
• Andreas Syngros Hospital of Veneral & Dermatological Diseases
  Athens, Greece Recruiting
• Hospital Of Skin And Venereal Diseases of Thessaloniki
  Thessaloniki, Greece Recruiting
• Hospital
  Modena, Italy Recruiting
• IDI Istituto Dermopatico dell'Immacolata IRCCS
  Rome, Italy Recruiting

Study contacts

• Study coordinator: Head of Clinical Development
• Email: info@xinnate.com
• Phone: 46462756000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Energy-F703EB Cream for Epidermolysis Bullosa: a skin cream test in adults

  This phase 2 study tests ENERGI-F703EB Cream versus a matching vehicle to see if it is safe and helps small EB skin lesions in adults.

  Recruiting Phase 2 Energenesis Biomedical Co., Ltd. · Tainan · NCT07858422

• Impact of Patient Position on EndoFLIP Measurements in Kids and Young Adults

  This study tests whether EndoFLIP measurements differ when patients are in the supine versus left-side position during the procedure.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT07780981

• Topical SD-101-6.0 cream for epidermolysis bullosa in children (1 month to 12 years)

  A phase 3 trial tests whether applying SD-101-6.0 cream to the whole body daily for 60 days helps wounds heal in young EB patients.

  Recruiting at 4 sites Phase 3 Paradigm Therapeutics · Rancho Santa Margarita, California and 3 other locations · NCT07482787

• Ev.FV to heal wounds in dystrophic epidermolysis bullosa

  This trial will test whether Ev.FV, a mesenchymal stem cell-derived extracellular vesicle therapy, helps heal wounds in people with dystrophic epidermolysis bullosa.

  Recruiting Phase 1/2 Isfahan University of Medical Sciences · Isfahan · NCT07230223

• KB803 eye drops versus placebo for people with dystrophic epidermolysis bullosa

  This trial tests whether KB803 eye drops, given three times a week, can reduce recurrent corneal abrasions in children and adults with dystrophic epidermolysis bullosa.

  Recruiting at 5 sites Phase 3 Krystal Biotech, Inc. · Rancho Santa Margarita, California and 4 other locations · NCT07016750

• Oleogel-S10 gel for healing skin wounds in Japanese patients with epidermolysis bullosa.

  We will try Oleogel‑S10 gel to see if it closes or shrinks wounds in Japanese children and adults with junctional or dystrophic epidermolysis bullosa.

  Recruiting at 6 sites Phase 3 Chiesi Farmaceutici S.p.A. · Fukuoka and 5 other locations · NCT06917690

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.