Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06791525 | RECRUITING | Warts Hand

Tirbanibulin for Pediatric Warts
Sponsor:

The Skin Center Dermatology Group

Information provided by (Responsible Party):

Dr. Peter C. Friedman

Brief 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.

Condition or disease

Warts Hand

Intervention/treatment

Tirbanibulin ointment 1%

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Single-arm, Open-label Study of Tirbanibulin 1% Ointment to Treat Warts on the Hands in Pediatric Patients
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2025-11-01
Estimated Study Completion Date : 2025-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 8 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Tirbanibulin for Pediatric Warts

Location Details

NCT06791525

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

The Skin Center Dermatology Group

New City, New York, United States, 10956