Topical treatment for superficial basal cell carcinoma
Open, Prospective Study Evaluating the Efficacy and Safety of 0.05% Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Alpes-maritimes) |
| Trial ID | NCT06112522 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have explored topical treatments for basal cell carcinoma, indicating potential effectiveness, but this specific approach with tirbanibulin is novel.
Eligibility criteria
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 this trial is running
Nice, Alpes-maritimes
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.