Tirbanibulin for Pediatric Warts

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Tirbanibulin for Pediatric Warts

Condition
Warts Hand
Intervention / Treatment

-

Contacts and Locations

New City

The Skin Center Dermatology Group, New City, New York, United States, 10956

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

8 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Skin Center Dermatology Group,

Study Record Dates

2025-12-30