Tirbanibulin ointment for treating warts in children

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

This study is testing if a new ointment can help treat hand warts in kids aged 8 to 18 more effectively and comfortably than current treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 8 Years to 18 Years
• Sex: All
• Sponsor: The Skin Center Dermatology Group (Industry-sponsored)
• Drugs / interventions: immunotherapy, methotrexate
• Locations: 1 site (New City, New York)
• Trial ID: NCT06791525 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of tirbanibulin ointment in treating hand warts in pediatric patients aged 8 to 18. Warts, caused by the human papillomavirus, are common and can be difficult to treat, especially in children who may not tolerate standard treatments well. The study aims to determine if tirbanibulin ointment can provide a more effective and tolerable alternative for this population. Participants will be assessed for their health status and wart characteristics before receiving the treatment.

Who should consider this trial

Good fit: Ideal candidates are children aged 8-18 with a diagnosis of hand warts and a wart count between 3-10.

Not a fit: Patients with a history of treatment failure with specific wart therapies or those with extensive wart involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and better-tolerated option for children suffering from hand warts.

How similar studies have performed: While there is limited data on tirbanibulin specifically, existing treatments for pediatric warts have shown variable success, indicating a need for novel approaches like this one.

Eligibility criteria

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

Where this trial is running

New City, New York

• The Skin Center Dermatology Group — New City, New York, United States (Recruiting)

Study contacts

• Study coordinator: Peter Friedman, MD, PhD

Conditions Warts Hand