Tirbanibulin for Pediatric Warts

Launched by THE SKIN CENTER DERMATOLOGY GROUP · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new ointment called tirbanibulin to see if it can effectively treat hand warts in children and teenagers aged 8 to 18. Warts, which are caused by a virus called human papillomavirus (HPV), can be tough to treat, especially in young people who may not tolerate standard treatments well. The trial aims to find out if this ointment is both safe and helpful for kids with a specific number of warts on their hands.

To participate, children must have between 3 and 10 warts on their hands and be in good health. They should not have had their warts for more than two years or tried certain other treatments that didn’t work for them. If eligible, participants will receive the tirbanibulin ointment and will be closely monitored for any changes or side effects. This study is important because it may offer a better treatment option for young patients suffering from warts.

Gender

ALL

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