RecruitingPhase 2NCT06594393

A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study

A Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Topically Applied TCP-25 in Patients With Epidermolysis Bullosa


Sponsor

Xinnate AB

Enrollment

32 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB. The study will implement intrasubject randomization, ie, a pair of matching index wounds will be randomly assigned to be treated with a local application of either TCP 25 gel or vehicle gel.


Eligibility

Min Age: 4 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study evaluates a topical gel called TCP-25 for treating open wounds in people with dystrophic or junctional epidermolysis bullosa (DEB or JEB) — rare genetic skin conditions where the skin blisters and wounds easily. The gel is applied to matched wound pairs, with one wound receiving the active treatment and the other receiving a placebo gel, to compare healing outcomes directly in the same person. Patients aged 4 and older with a confirmed genetic diagnosis of DEB or JEB who are not currently on systemic antibiotics may be eligible. Participation involves clinic visits every 2 weeks for 8 weeks to apply the gel and photograph wounds, followed by a safety phone call at 2 weeks after treatment ends. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTCP-25 gel

Topical gel

DRUGVehicle (placebo)

Placebo gel


Locations(9)

Hopital St Louis

Paris, France

Andreas Syngros Hospital of Veneral & Dermatological Diseases

Athens, Greece

Hospital Of Skin And Venereal Diseases of Thessaloniki

Thessaloniki, Greece

IDI Istituto Dermopatico dell'Immacolata IRCCS

Rome, Italy

San Joan de Deu, SJD Children's hospital Barcelona

Barcelona, Catalonia, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Univ La Paz

Madrid, Spain

University hospital

Lund, Skåne County, Sweden

Akademiska sjukhuset

Uppsala, Sweden

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NCT06594393


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