Tirbanibulin for Pediatric Warts

The Skin Center Dermatology Group

Status and phase: Enrolling; Phase 4

Conditions: Warts Hand

Treatments: Drug: Tirbanibulin ointment 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06791525

TIRBAVV

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No 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:

5. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Topical treatment arm

Experimental group

Description:

Topical medication self-applied

Treatment:

Drug: Tirbanibulin ointment 1%