Study of Efficacy of TCP-25 in Patients with Epidermolysis Bullosa, EB (STEP)

Xinnate is conducting a Phase 2 research study to determine if TCP-25, a topical anti-inflammatory and antibacterial gel, can effectively promote and maintain wound healing in patients with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB).

Two wounds per person will be included. One wound will be treated with TCP-25 gel and one with placebo gel for 8 weeks. The treatment is applied in connection with dressing changes at home and at 6 visits to the study clinic. The total duration of the study is 3 months.

Trial Entry Criteria

You may be eligible to participate if you:

• Have a clinical diagnosis of the recessive or dominant form of dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB)
• Age 4 years or older at the time of consent
• Have at least two wounds that are similar in size and location
• Are able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all required follow-up visits

Locations

The study is conducted in France, Spain, Italy, Greece, Sweden and the US.

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