An Open-Label Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
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.
Description
32 patients are planned to be enrolled into the study from 2-4 US sites. This study will be an Open-Label Study where all patients will be treated with the investigational product EX-02. Enrollment will be conducted in 2 stages. In the first stage, a group of sixteen (16) patients will be enrolled and treated as detailed below for group 1. Safety results from the first group of patients will be evaluated by the sponsor and by the DSMB. Based on the safety results and DSMB recommendations, the second group of patients will include additional 16 patients that will be enrolled and treated, as de…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Inclusion Criteria- Patient level 1. Male or female greater than age 18, 2. Patients with one primary superficial or nodular basal cell carcinoma lesion (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy. 3. Lesion is present for no longer than 4 years. 4. Lesion with a diameter of 5-10mm, 5. Patient and/or legally authorized representative (LAR) understands the nature of the procedure, is able and willing to adhere to the protocol regimen, and able to provide a wr…
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.
Locations (3)
- Center for Clinical and Cosmetic ResearchAventura, Florida
- Moore Clinical Research, Inc.Brandon, Florida
- Center for Clinical Studies, LTD. LLPWebster, Texas