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
Qualifiers
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
Treatments tested in this trial
- EscharEx 5% (EX-02 formulation)
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov