Open-label, prospective study evaluating the efficacy and safety of Tirbanibulin 1% (Klisyri®) in the treatment of superficial basal cell carcinoma
- Conditions
- Superficial Basal cell carcinomaMedDRA version: 20.0Level: PTClassification code: 10004146Term: Basal cell carcinoma Class: 100000004864Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-505971-66-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Nice
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
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.
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method