Recruiting

Tirbanibulin

Sponsor:

The Skin Center Dermatology Group

Code:

NCT06791525

Conditions

Warts Hand

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Tirbanibulin ointment 1%

Study Details

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.

Conditions

Warts Hand

Study ID

NCT06791525

Start date

May 1, 2025

Status verified date

Apr, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Topical treatment arm

Topical medication self-applied

Interventions

Tirbanibulin ointment 1%

Topical application

Primary outcome measure

  • Resolution [ Time Frame: 2 months aftre completion of 4 or less treatment cycles ]

Central Contacts and Locations

Central contacts

Locations

The Skin Center Dermatology Group

Recruiting

New City, New York, United States, 10956

Contacts

Eszter Friedman, Clinical Research Coordinator

315-616-3706trial@skincenterderm.com

Principal Investigator:

Peter Friedman, Principal Investigator, MD PhD

More Information

Sponsor

The Skin Center Dermatology Group

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Skin Center Dermatology Group on 2026-04-23.