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NCT Number: NCT06791525

Tirbanibulin for Pediatric Warts

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.

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Key information

Conditions

Warts Hand

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Skin Center Dermatology Group

New City, New York, 10956, United States

Location status: Recruiting

Location contact

Eszter Friedman, Clinical Research Coordinator

CONTACT

[email protected]

315-616-3706

Peter Friedman, Principal Investigator, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tirbanibulin ointment 1%

Drug

Topical application

Primary outcomes

  1. Resolution

    Time frame: 2 months aftre completion of 4 or less treatment cycles

    Ful resolution of treated lesions

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Friedman, MD, PhD

CONTACT

[email protected]

8453520500

Sponsors and collaborators

Lead sponsor

The Skin Center Dermatology Group

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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