Topical treatment for superficial basal cell carcinoma
Official title: Open, Prospective Study Evaluating the Efficacy and Safety of 0.05% Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma
Run by Centre Hospitalier Universitaire de Nice · NCT06112522 · Data updated 2026-11-12
This study is testing a new ointment to see if it can safely treat superficial basal cell carcinoma in adults when the cancer is not on the face or scalp.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Alpes-maritimes) |
| Status | Recruiting |
| Started | February 16, 2024 |
| Main results expected | December 16, 2027 |
| Study ends | December 16, 2027 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT06112522 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with histologically confirmed, primary, untreated superficial basal cell carcinoma not located on the face or scalp, and measuring 15 mm or less.
✕Probably not a fit
Patients with basal cell carcinoma on the face or scalp, non-superficial subtypes, or those who have received prior treatments in the affected area may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 clinical trial evaluates the efficacy and safety of a 1% tirbanibulin ointment in adults with superficial basal cell carcinoma (sBCC) that does not occur on the face or scalp. The study will include 55 participants, accounting for potential exclusions, and will assess the treatment's effectiveness based on histologically confirmed cases. Participants will undergo a selection visit followed by an inclusion visit where consent will be obtained and clinical evaluations conducted.
Why it matters
Potential benefit: If successful, this treatment could provide a new topical option for patients with superficial basal cell carcinoma, potentially improving outcomes and quality of life.
How similar studies have gone: Previous studies have explored topical treatments for basal cell carcinoma, indicating potential effectiveness, but this specific approach with tirbanibulin is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Histologically confirmed, * primary, previously untreated, * superficial basal cell carcinoma (sBCC) not arising on the face or scalp, ≤ 15 mm (large axis) Exclusion Criteria: * BCC of the face or scalp * BCC of non-superficial subtype * BCC with large axis \> 15mm * Relapsing BCC * Allergy to treatment * Treatment with cryotherapy, imiquimod, PDT, or radiotherapy in the BCC area during the 6 months prior to the screening visit
Where it's running
-
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-maritimes, France Recruiting
Study contacts
- Principal investigator: philippe Bahadoran, PhD — CHU de Nice, Service de Dermatologie
- Study coordinator: Philippe Bahadoran, PhD
- Email: bahadoran.p@chu-nice.fr
- Phone: +33492036223
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.