CTIS2023-505971-66-00
Recruiting
Phase 1
Open-label, prospective study evaluating the efficacy and safety of Tirbanibulin 1% (Klisyri®) in the treatment of superficial basal cell carcinoma - 23-PP-04
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Enrollment
- 55
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female patients over 18 years of age., Patients with one or more primary, superficial BCCs of the trunk or limbs confirmed by LC\-OCT., Primitive BCC, long axis less than or equal to 15 mm., Patient affiliated to a Social Security scheme., Patient likely to understand study instructions., Signed informed consent. If necessary, a legal representative can sign the consent form.
Exclusion Criteria
- •BCC scalp and face, Recurrent BCC, Non\-superficial BCC, BCC diameter \> 15 mm, Patient allergic to Tirbanibulin to an excipient of the finished product, Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the treatment area within 6 months prior to the first visit, Pregnant or breast\-feeding women (a urine pregnancy test will be performed), Current participation or less than 30 days' participation in a clinical drug trial, Any medical or psychiatric condition that could prevent the proper understanding and conduct of treatment and study (adults under guardianship)
Outcomes
Primary Outcomes
Not specified
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