Tirbanibulin for Pediatric Warts

Last updated: May 12, 2025
Sponsor: The Skin Center Dermatology Group
Overall Status: Active - Recruiting

Phase

4

Condition

Warts

Treatment

Tirbanibulin ointment 1%

Clinical Study ID

NCT06791525
TIRBAVV
  • Ages 8-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 8-18

  2. Subject and their legally authorized representative must be able to understand andbe willing to adhere to all protocol requirements and voluntarily sign and dateinformed 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

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

  6. intralesional cidofovir 5. Any over the counter, prescription topical, orin-office procedural wart treatment within 6 weeks of baseline (Day 1) 6. Knownimmuno-suppressed state due to disease or medication, medical treatment o 7. Knownallergy to any component of the IP 8. Any conditions that, in the PrincipalInvestigator's opinion, may interfere with the course of the study

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Tirbanibulin ointment 1%
Phase: 4
Study Start date:
May 01, 2025
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • The Skin Center Dermatology Group

    New City, New York 10956
    United States

    Active - Recruiting

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