Home › NCT06791525
Tirbanibulin for Pediatric Warts
Single-arm, Open-label Study of Tirbanibulin 1% Ointment to Treat Warts on the Hands in Pediatric Patients
Who can join
Ages 8 to 18 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Age 8-18 2. Subject and their legally authorized representative must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date informed consent and assent for minors. 3. Subject is judged to be in good health as determined by the Principal Investigator, based upon the results of the screening assessments and medical history. 4. Diagnosis of warts on the hands 5. Wart count on the hands and 3-10 Exclusion Criteria: 1. Wart duration \>2 years. 2. More than 10 warts in non-hand areas. 3. Total wart surface area on the hands bigger than 100 cm2 4. Prior treatment failure with the following modalities: 1\. intralesional immunotherapy 2. intralesional bleomycin, 5-fluorouracil, methotrexate 3. intralesional cidofovir 5. Any over the counter, prescription topical, or in-office procedural wart treatment within 6 weeks of baseline (Day 1) 6. Known immuno-suppressed state due to disease or medication, medical treatment o 7. Known allergy to any component of the IP 8. Any conditions that, in the Principal Investigator's opinion, may interfere with the course of the study
About the study
Warts are common, benign skin lesions caused by the human papillomavirus (HPV). Treatment is challenging, particularly in the pediatric population, where standard modalities such as cryotherapy and intralesional immunotherapy are poorly tolerated. Existing topical treatments, such as imiquimod and 5-fluorouracil, have low efficacy and require prolonged use. Case reports suggest tirbanibulin ointment may provide an effective and well-tolerated alternative for pediatric warts. This study will evaluate the efficacy and safety of tirbanibulin ointment in treating pediatric hand warts.
What is being tested
- Tirbanibulin ointment 1% (drug)
Sponsor: The Skin Center Dermatology Group · Participants: 10 · Started: May 1, 2025
Contact the study team
- Peter Friedman, MD, PhD · Phone: 8453520500
Official record on ClinicalTrials.gov — NCT06791525
Locations in the U.S.
| New York | The Skin Center Dermatology Group, New City |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.