RecruitingPhase 1Phase 2NCT05157763

A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma

An Open-Label Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma

Sponsor

MediWound Ltd

Enrollment

32 participants

Start Date

Jun 30, 2021

Study Type

INTERVENTIONAL

Conditions

Superficial Basal Cell Carcinoma Nodular Basal Cell Carcinoma

Summary

This study will be a multicenter, prospective, open label, one-arm study intended to assess the Safety and Efficacy of EscharEx (EX-02) in the treatment of Basal Cell Carcinoma. In patients with one primary superficial or nodular basal cell carcinoma lesion with a diameter of 5-10mm (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a topical gel called EscharEx (EX-02) — made from pineapple and papaya enzymes — as a non-surgical treatment for basal cell carcinoma (BCC), the most common type of skin cancer. Researchers want to see if it can safely dissolve small BCC tumors on the skin. **You may be eligible if...** - You are 18 years of age or older - You have one confirmed superficial or nodular basal cell carcinoma on your trunk or upper arm (not hands), with clear borders and no prior radiation to that spot - The lesion has been present for 4 years or less - The lesion is between 5 and 10 mm in diameter **You may NOT be eligible if...** - You have Gorlin syndrome or metastatic cancer - You have another type of skin cancer at the same location - You have the aggressive "morphea-type" basal cell carcinoma - There are signs of infection at the lesion site - You have a skin disease in or around the treatment area - You are allergic to pineapple, papaya, bromelain, papain, latex, bee venom, or olive products Talk to your doctor to see if this trial is right for you.

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

DRUGEscharEx 5% (EX-02 formulation)

EX-02 5% will be topically applied in a thick layer of 2-3 mm on the lesion surface for 8-12 hours including 5-10 mm margins and covered with an occlusive dressing. A new vial should be used for each application. Each patient will be treated with 7 applications.