Tirbanibulin for Warts

Overseen By Peter Friedman, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: The Skin Center Dermatology Group

Must not be taking: Immunosuppressants, others

Disqualifiers: Immunosuppressed, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for children aged 8-18 with a diagnosis of hand warts, having between 3 to 10 warts. Participants must be in good health as determined by the study's doctor and both the child and their guardian must understand the study requirements and agree to participate.

Inclusion Criteria

I am between 8 and 18 years old.

The doctor considers me in good health based on my tests and history.

I understand the study requirements and agree to follow them.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-apply tirbanibulin 1% ointment to treat warts on the hands

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Tirbanibulin

Trial Overview The trial is testing Tirbanibulin ointment at a concentration of 1% to see if it's effective and safe for treating pediatric hand warts, which are typically hard to treat with current options like cryotherapy or topical imiquimod.

Participant Groups

Group I: Topical treatment arm Experimental Treatment 1 Intervention

Topical medication self-applied

Who Is Running the Clinical Trial?

The Skin Center Dermatology Group

Lead Sponsor

Trials

5

Recruited

170+