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