Tirbanibulin for Pediatric Warts

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06791525

Enrollment

Registered

2025-01-24

Start date

2025-05-01

Completion date

2026-12-30

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Warts Hand

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.

Interventions

DRUGTirbanibulin ointment 1%

Topical application

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTPeter Friedman, MD, PhD

drfriedman@skincenterderm.com8453520500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026