Superficial Basal Cell Carcinoma Clinical Trial
Official title:
An Open-Label Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | June 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Inclusion Criteria- Patient level 1. Male or female greater than age 18, 2. 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. 3. Lesion is present for no longer than 4 years. 4. Lesion with a diameter of 5-10mm, 5. 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. Exclusion Criteria: Exclusion Criteria- Patient level 1. Evidence of Gorlin syndrome, neoplastic diseases (except actinic lesions), metastatic tumor or tumor with high probability of metastatic spread, 2. Other malignant cancers (non BCC) of the skin at the lesion's site, 3. Morphea-type basal cell carcinoma (MBCC) at the lesion's site (per biopsy report), 4. Any signs of infection at the lesion site including purulent discharge, tissue abscess, erysipelas, cellulitis, etc., 5. Patients with any dermatological disease in the target lesion site or surrounding area (not including chronic actinic damage in the surrounding area), 6. History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen, 7. Patients undergoing renal or peritoneal dialysis, 8. Any condition that would preclude safe participation in the study, e.g. evidence of significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, or any immediate life threatening condition, 9. Concurrent acute injury or disease that might compromise the patient's welfare or the participation in the study, 10. Current (within last 12 months) severe alcohol or drug use disorder 11. Pregnant women (positive blood or urine pregnancy test) or nursing mothers, 12. Exposure to investigational intervention within 4 weeks prior to enrolment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Clinical and Cosmetic Research | Aventura | Florida |
United States | Moore Clinical Research, Inc. | Brandon | Florida |
United States | Center for Clinical Studies, LTD. LLP | Webster | Texas |
Lead Sponsor | Collaborator |
---|---|
MediWound Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Through study completion - an average of 16 weeks | |
Primary | Vital signs - proportion of patients with abnormal clinical significant measurements | Assessed pre 2nd, pre 5th application and post last application | Up to completion of treatment period - up to 5 weeks | |
Primary | 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 | Up to completion of treatment period - up to 5 weeks | |
Primary | 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. | Up to completion of treatment period - up to 5 weeks | |
Primary | Proportion of subjects that requested to discontinue the treatment | This will be assessed over the entire course of the treatment and will be calculated, together with its 95% confidence interval based on the binomial distribution | Up to completion of treatment period - up to 5 weeks | |
Secondary | 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. | Up to 13 weeks | |
Secondary | 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. | Up to 13 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04552990 -
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT03573401 -
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
|
Phase 3 | |
Completed |
NCT03012009 -
Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial
|
N/A | |
Completed |
NCT02270645 -
Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser
|
N/A | |
Completed |
NCT00469417 -
Metvix PDT Versus Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
|
Phase 3 | |
Recruiting |
NCT05381597 -
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
|
Phase 2/Phase 3 | |
Terminated |
NCT00994240 -
Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC
|
N/A | |
Completed |
NCT00604890 -
Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma
|
Phase 1/Phase 2 | |
Completed |
NCT00189306 -
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
|
Phase 3 | |
Recruiting |
NCT04744935 -
Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
|
N/A | |
Completed |
NCT05628714 -
A Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma
|
||
Completed |
NCT00432185 -
To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC
|
Phase 2 | |
Recruiting |
NCT01491711 -
Superficial Basal Cell Carcinoma Treatment With Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Methylaminolevulinate
|
Phase 4 | |
Completed |
NCT04470726 -
Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma
|
Phase 1/Phase 2 | |
Completed |
NCT01325688 -
PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities
|
Phase 2 | |
Recruiting |
NCT05713760 -
Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults
|
Phase 2 |