Tirbanibulin for Pediatric Warts

Phase 4

Recruiting

• Conditions: Warts Hand
• Interventions: Drug: Tirbanibulin ointment 1%

• Registration Number: NCT06791525
• Lead Sponsor: The Skin Center Dermatology Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-19
• Study First Posted: 2025-01-24
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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:

5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical treatment arm	Tirbanibulin ointment 1%	Topical medication self-applied

Primary Outcome Measures

Name	Time	Method
Resolution	2 months aftre completion of 4 or less treatment cycles	Ful resolution of treated lesions

Trial Locations

Locations (1)

The Skin Center Dermatology Group; 🇺🇸 New City, New York, United States