Tirbanibulin for Pediatric Warts

NCT06791525 | Recruiting Phase 4 FDA Drug

• 1 other identifier: TIRBAVV
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Warts Hand

Outcome Measures

Primary Outcomes (1)

• Resolution

  Ful resolution of treated lesions

  2 months aftre completion of 4 or less treatment cycles

Study Arms (1)

Topical treatment arm

EXPERIMENTAL

Topical medication self-applied

Drug: Tirbanibulin ointment 1%

Interventions

Tirbanibulin ointment 1% DRUG

Topical application

Topical treatment arm

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8-18
• 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.
• 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.
• Diagnosis of warts on the hands
• Wart count on the hands and 3-10

You may not qualify if:

• Wart duration \>2 years.
• More than 10 warts in non-hand areas.
• Total wart surface area on the hands bigger than 100 cm2
• Prior treatment failure with the following modalities:
• \. 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

Sponsors & Collaborators

• The Skin Center Dermatology Group: lead

Study Sites (1)

The Skin Center Dermatology Group

New City, New York, 10956, United States

RECRUITING

Central Study Contacts

Peter Friedman, MD, PhD

CONTACT

8453520500; drfriedman@skincenterderm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)