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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical treatment arm | Experimental | Topical medication self-applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirbanibulin ointment 1% | Drug | Topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution | Ful resolution of treated lesions | 2 months aftre completion of 4 or less treatment cycles |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Friedman, MD, PhD | Contact | 8453520500 | drfriedman@skincenterderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Skin Center Dermatology Group | Recruiting | New City | New York | 10956 | United States |
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