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NCT05157763 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
A Phase 1 study of Superficial Basal Cell Carcinoma and Nodular Basal Cell Carcinoma, sponsored by MediWound.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 3
- Study locations
NCT05157763: Recruiting Phase 1 study of Superficial Basal Cell Carcinoma and Nodular Basal Cell Carcinoma, sponsored by MediWound.
NCT05157763 is a Phase 1 study of Superficial Basal Cell Carcinoma and Nodular Basal Cell Carcinoma that is actively recruiting participants, run by MediWound. The registered enrollment target is 32 participants, below the 110-participant average among 5 other Superficial Basal Cell Carcinoma trials with a reported enrollment target (71% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05157763, a Phase 1 study of Superficial Basal Cell Carcinoma and Nodular Basal Cell Carcinoma, is actively recruiting participants, sponsored by MediWound.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG EscharEx 5% (EX-02 formulation)
Study Locations (3)
Florida
- Center for Clinical and Cosmetic Research - Aventura
- Moore Clinical Research, Inc. - Brandon
Texas
- Center for Clinical Studies, LTD. LLP - Webster
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2022-06 |
| Phase | Phase 1 |
What NCT05157763 shows while recruiting
NCT05157763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 110-participant average among 5 other Superficial Basal Cell Carcinoma trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Superficial Basal Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which EscharEx 5% (EX-02 formulation) is the first listed.
NCT05157763 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05157763 about?
NCT05157763 is a clinical study titled "A 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...
What is the current status of trial NCT05157763?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2021-06-30. Estimated completion is 2022-06.
What conditions does trial NCT05157763 study?
This clinical trial studies the following conditions: Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma.
What interventions are being tested in trial NCT05157763?
The interventions under investigation include: EscharEx 5% (EX-02 formulation) (DRUG).
Who is sponsoring clinical trial NCT05157763?
This trial is sponsored by MediWound, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05157763 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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