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

Part of paid clinical trials in Aventura, Florida.

Sponsor
MediWound Ltd
Study ID
NCT05157763
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Nodular Basal Cell Carcinoma
  • Superficial Basal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EscharEx 5% (EX-02 formulation) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2021
Status verified
Dec 2021
Primary completion
May 31, 2022
Completion
Jun 30, 2022

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Incidence and severity of treatment-emergent AEs (TEAEs) and serious TEAEs (STEAEs). [ Time Frame: Through study completion - an average of 16 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Center for Clinical and Cosmetic ResearchAventuraFlorida33180
Brian Berman, MD
Brian Berman, MD (PRINCIPAL_INVESTIGATOR)
Moore Clinical Research, Inc.BrandonFlorida33511
Michael Bland, VP
[email protected]
813-948-7550
Stanley N Katz, MD (PRINCIPAL_INVESTIGATOR)
Center for Clinical Studies, LTD. LLPWebsterTexas77598
Stephen Tyring, MD
[email protected]
281-333-2288
Stephen Tyring, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aventura, FL

By research site
Center for Clinical and Cosmetic Research· Aventura, FLMoore Clinical Research, Inc.· Brandon, FLCenter for Clinical Studies, LTD. LLP· Webster, TX

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