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

Who is this study for? Patients with Basal Cell Carcinoma

What treatments are being studied? EscharEx 5% (EX-02 Formulation)

Status: Recruiting

Location: See all (3) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1/Phase 2

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

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Male or female greater than age 18,

• 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.

• Lesion is present for no longer than 4 years.

• Lesion with a diameter of 5-10mm,

• 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 written informed consent prior to any study procedure.

Locations

United States

Florida

Center for Clinical and Cosmetic Research

RECRUITING

Aventura

Moore Clinical Research, Inc.

NOT_YET_RECRUITING

Brandon

Texas

Center for Clinical Studies, LTD. LLP

RECRUITING

Webster

Contact Information

Primary

Limor Dinur Klein, PhD

limord@mediwound.com

972779714000

Backup

Keren David, MSc

kerend@mediwound.com

Time Frame

Start Date: 2021-06-30

Estimated Completion Date: 2022-06

Participants

Target number of participants: 32

Treatments

Experimental: EscharEx 5%

The powder of EX-02 (4 g per vial) should be reconstituted with 10 ml water for injection (WFI) to obtain 5% EX-02 gel. The EX-02 powder and the WFI are to be mixed up to 15 min prior to use. EX-02 5% gel will be topically applied in a thick layer of 2-3 mm on the lesion surface including margin of 5-10 mm for 8-12 hours (preferable over-night) and covered with an occlusive dressing. A new vial should be used for each application. Each patient will be treated with 7 applications.

Related Therapeutic Areas

Basal Cell Skin Cancer

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