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Virus Therapy

EscharEx 5% for Basal Cell Carcinoma

Phase 1 & 2
Waitlist Available
Research Sponsored by MediWound Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion - an average of 16 weeks
Awards & highlights

Study 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.

Eligible Conditions
  • Basal Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion - an average of 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion - an average of 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of treatment-emergent AEs (TEAEs) and serious TEAEs (STEAEs).
Pain assessments- Proportion of patients with clinical significant elevation in NPRS score
Proportion of subjects discontinuing a treatment due to TEAEs, assessed over the entire course of the treatment.
+2 more
Secondary outcome measures
Proportion of patients who reached complete clearance at the end of the post treatment period, as clinically assessed prior to surgical removal.
Proportion of patients who reached complete histological clearance at the end of the post treatment period.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EscharEx 5%Experimental Treatment1 Intervention
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.

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Who is running the clinical trial?

MediWound LtdLead Sponsor
11 Previous Clinical Trials
997 Total Patients Enrolled
Lior Rosenberg, Prof.Study DirectorMediWound Ltd
2 Previous Clinical Trials
157 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
2021. "A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157763.
~9 spots leftby Apr 2025
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