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RECRUITING
NCT05157763
PHASE1/PHASE2

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

Sponsor: MediWound Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2021-06-30

Completion Date

2022-06

Last Updated

2021-12-15

Healthy Volunteers

No

Interventions

DRUG

EscharEx 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.

Locations (3)

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

Moore Clinical Research, Inc.

Brandon, Florida, United States

Center for Clinical Studies, LTD. LLP

Webster, Texas, United States