Actively Recruiting
Single-arm, Open-label Study of Tirbanibulin 1% Ointment to Treat Warts on the Hands in Pediatric Patients
Led by The Skin Center Dermatology Group · Updated on 2026-04-23
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Warts on the hands are common, non-cancerous skin growths caused by the human papillomavirus (HPV). Treating warts in children can be difficult because common treatments like cryotherapy and injections are often not well tolerated. Existing creams have limited success and require long use. Researchers are studying tirbanibulin ointment as a possible effective and better-tolerated treatment for hand warts in children aged 8 to 18 years. Participants will apply tirbanibulin ointment 1% to the affected areas on their hands themselves. This study is open-label and involves one treatment group using only this topical medication. Treatment cycles will last up to four cycles, with participants applying the ointment as directed during the study period. During the study, children will be monitored for wart clearance two months after finishing treatment cycles. Assessments will include wart count and size, overall health status, and any side effects. The study will last through treatment and follow-up, ensuring safety and measuring how well the ointment works to clear warts on the hands.
CONDITIONS
Brief Title
Tirbanibulin for Pediatric Warts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8 to 18 years
- Subject and legally authorized representative can understand and agree to study requirements and consent
- Subject is in good health based on screening and medical history
- Diagnosis of warts on the hands
- Wart count on hands is between 3 and 10
You will not qualify if you...
- Wart duration longer than 2 years
- More than 10 warts outside the hands
- Total wart surface area on hands larger than 100 cm2
- Prior treatment failure with intralesional immunotherapy, bleomycin, 5-fluorouracil, methotrexate, or cidofovir
- Any wart treatment (over the counter, prescription, or procedural) within 6 weeks before baseline
- Known immunosuppression due to disease or medication
- Known allergy to any component of the investigational product
- Any condition that may interfere with the study as judged by the Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 treatment cycles
Participants apply Tirbanibulin 1% ointment topically to warts on their hands.
Duration - 2 months after completion of treatment
Participants are observed for resolution of warts after completing treatment cycles.
Trial Site Locations
Total: 1 location
1
The Skin Center Dermatology Group
New City, New York, United States, 10956
Actively Recruiting
Research Team
P
Peter Friedman, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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