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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• Age 8-18

• 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.

• 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.

• Diagnosis of warts on the hands

• Wart count on the hands and 3-10

Locations
United States
New York
The Skin Center Dermatology Group
RECRUITING
New City
Contact Information
Primary
Peter Friedman, MD, PhD
drfriedman@skincenterderm.com
8453520500
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 10
Treatments
Experimental: Topical treatment arm
Topical medication self-applied
Related Therapeutic Areas
Sponsors
Leads: The Skin Center Dermatology Group

This content was sourced from clinicaltrials.gov

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