Actively Recruiting
A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
Led by MediWound Ltd · Updated on 2021-12-15
32
Participants Needed
3
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female greater than age 18
- One primary superficial or nodular basal cell carcinoma lesion confirmed by biopsy
- Lesion located on the trunk or upper extremities, excluding hands
- Lesion present for no longer than 4 years
- Lesion diameter between 5 and 10 mm
- Ability to understand the study, follow the protocol, and provide written informed consent
You will not qualify if you...
- Evidence of Gorlin syndrome, neoplastic diseases (excluding actinic lesions), metastatic tumors, or tumors with high metastatic risk
- Other malignant skin cancers at the lesion site
- Morphea-type basal cell carcinoma at the lesion site
- Signs of infection at the lesion site, such as discharge or abscess
- Any dermatological disease in or around the lesion area except chronic actinic damage
- History of allergy or sensitivity to pineapples, papaya, bromelain, papain, latex proteins, bee venom, or olive tree pollen
- Undergoing renal or peritoneal dialysis
- Significant or unstable heart, lung, liver, blood, immune, or life-threatening conditions
- Current acute injury or disease affecting welfare or study participation
- Severe alcohol or drug use disorder within the last 12 months
- Pregnant or nursing women
- Participation in another investigational drug or intervention trial within 4 weeks prior or during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
Actively Recruiting
2
Moore Clinical Research, Inc.
Brandon, Florida, United States, 33511
Not Yet Recruiting
3
Center for Clinical Studies, LTD. LLP
Webster, Texas, United States, 77598
Actively Recruiting
Research Team
L
Limor Dinur Klein, PhD
CONTACT
K
Keren David, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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