Actively Recruiting
An Open-Label Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
Led by MediWound Ltd ยท Updated on 2021-12-15
32
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of EscharEx (EX-02) in treating basal cell carcinoma, a type of skin cancer. This open-label, multicenter study focuses on patients with a single primary superficial or nodular basal cell carcinoma lesion measuring 5 to 10 mm on the trunk or upper extremities, excluding hands. The purpose is to assess how well the topical treatment works and monitor any treatment-related side effects. All participants will receive the investigational EscharEx 5% gel applied topically in a thick layer to the lesion and surrounding margin for 8 to 12 hours per application. The treatment involves 7 applications in total, with two groups receiving different schedules: the first group applies the gel every other day over two weeks, and the second group applies it daily for one week, adjusted based on safety and tolerability. After treatment, patients will undergo surgical excision of the lesion and be followed until the lesion clearance and wound closure are confirmed. Participants will be involved in multiple stages including a screening period of up to two weeks, a treatment period of 1 to 3 weeks with 10 to 14 clinic visits for application and assessment, an 8-week post-treatment period with bi-weekly follow-ups to monitor wound healing, and a follow-up phase after surgical excision to confirm complete clearance. Assessments include photography of the lesion, adverse event monitoring, vital signs, pain evaluations, and local lab tests. The total duration of participation is approximately 14 to 17 weeks.
CONDITIONS
Brief 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 millimeters
- Ability and willingness to provide written informed consent and follow study procedures
You will not qualify if you...
- Diagnosis of Gorlin syndrome or neoplastic diseases other than actinic lesions
- Presence of other malignant skin cancers at the lesion site
- Morphea-type basal cell carcinoma at the lesion site
- Signs of infection at the lesion site, including purulent discharge or cellulitis
- Any dermatological disease at or around the lesion site, excluding chronic actinic damage
- Allergy or sensitivity to pineapples, papaya, bromelain, papain, latex proteins, bee venom, or olive tree pollen
- Currently undergoing renal or peritoneal dialysis
- Significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, or life-threatening conditions
- Acute injuries or diseases that could affect participation
- Severe alcohol or drug use disorder within the past 12 months
- Pregnant or nursing women
- Recent or planned participation in other investigational drug or intervention trials within 4 weeks prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 to 3 weeks
Participants will receive topical applications of EscharEx 5% on the basal cell carcinoma lesion. Group 1 will have 7 applications every other day over 2 weeks, and Group 2 will have 7 daily applications with possible adjustments for tolerability. Applications and assessments will be performed at the clinic, with dressing removal done at home by participants or caregivers. Lesions will be photographed and adverse events assessed before and after dressing removal.
10 to 14 visits including 7 treatment application visits and 3 post dressing removal assessment visits, with up to 4 optional visits
Duration - 8 weeks
Participants will have their treatment area cared for with topical agents to promote healing. Every two weeks, the treated area will be photographed and healing assessed along with adverse events. The first three visits can be in-person or remote, and the final visit will be on-site with surgical excision and biopsy performed.
4 bi-weekly visits (first 3 remote or in-person, final visit in-person)
Duration - Approximately 4 weeks or until wound closure
Participants will be followed until complete clearance of the basal cell carcinoma is confirmed by biopsy and the wound is closed. Follow-up includes monitoring adverse events and recording any additional procedures needed for clearance or wound closure.
At least 1 visit after biopsy results are available
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
K
Keren David, MSc
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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