Tirbanibulin for Pediatric Warts

Single-arm, Open-label Study of Tirbanibulin 1% Ointment to Treat Warts on the Hands in Pediatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Warts Hand
• Intervention / Treatment: Drug: Tirbanibulin ointment 1%

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Peter Friedman, MD, PhD; Phone Number: 8453520500; Email: drfriedman@skincenterderm.com

Study Locations

• United States
  • New York
    • New City, New York, United States, 10956
      • Recruiting
      • The Skin Center Dermatology Group
      • Contact: Eszter Friedman, Clinical Research Coordinator; Phone Number: 315-616-3706; Email: trial@skincenterderm.com
      • Principal Investigator: Peter Friedman, Principal Investigator, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical treatment arm; Topical medication self-applied	Drug: Tirbanibulin ointment 1%; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution	Ful resolution of treated lesions	2 months aftre completion of 4 or less treatment cycles

Collaborators and Investigators

• Sponsor: The Skin Center Dermatology Group

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases; DNA Virus Infections; Skin Diseases; Skin Diseases, Infectious; Tumor Virus Infections; Skin Diseases, Viral; Papillomavirus Infections; Warts; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tirbanibulin
• Other Study ID Numbers: TIRBAVV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No