A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediWound Ltd
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
Evidence of Gorlin syndrome, neoplastic diseases (except actinic lesions), metastatic tumor or tumor with high probability of metastatic spread,
Other malignant cancers (non BCC) of the skin at the lesion's site,
Morphea-type basal cell carcinoma (MBCC) at the lesion's site (per biopsy report),
Any signs of infection at the lesion site including purulent discharge, tissue abscess, erysipelas, cellulitis, etc.,
Trial design
Design model
Sequential
Treatments tested in this trial
EscharEx 5% (EX-02 formulation)
DrugEX-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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: EscharEx 5%Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent AEs (TEAEs) and serious TEAEs (STEAEs).
All adverse events (AEs) will be listed. Adverse events records will include notification whether the AE is local and occurs near or in the target lesion. The AEs will be listed as counts and percentages by System Organ Class (SOC), Preferred Term (PT), severity, and time of onset. Serious Adverse Events will be analyzed in the same way as AEs
Time frame
Through study completion - an average of 16 weeks2
Vital signs - proportion of patients with abnormal clinical significant measurements
Assessed pre 2nd, pre 5th application and post last application
Time frame
Up to completion of treatment period - up to 5 weeks3
Pain assessments- Proportion of patients with clinical significant elevation in NPRS score
Assesed pre 2nd, pre 5th application and post last application compared with pre 1st application
Time frame
Up to completion of treatment period - up to 5 weeks4
Proportion of subjects discontinuing a treatment due to TEAEs, assessed over the entire course of the treatment.
This proportion will be calculated, together with its 95% confidence interval based on the binomial distribution.
Time frame
Up to completion of treatment period - up to 5 weeksSecondary outcomes
1
Proportion of patients who reached complete histological clearance at the end of the post treatment period.
biopsy will be taken 8 weeks post completion of treatment. The proportion of patients who reached complete histological clearance at the end of the post treatment period, together with its 95% confidence interval based on the binomial distribution.
Time frame
Up to 13 weeks2
Proportion of patients who reached complete clearance at the end of the post treatment period, as clinically assessed prior to surgical removal.
The proportion of patients who reached complete histological clearance as assessed by the investigator at the end of the post treatment period, prior to the excisional biopsy, together with its 95% confidence interval based on the binomial distribution.
Time frame
Up to 13 weeksSponsors and contacts
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Source ClinicalTrials.gov