Tirbanibulin ointment for treating warts in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of tirbanibulin ointment in treating hand warts in pediatric patients aged 8 to 18. Warts, caused by the human papillomavirus, are common and can be difficult to treat, especially in children who may not tolerate standard treatments well. The study aims to determine if tirbanibulin ointment can provide a more effective and tolerable alternative for this population. Participants will be assessed for their health status and wart characteristics before receiving the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• The Skin Center Dermatology Group
  New City, New York, United States Recruiting

Study contacts

• Study coordinator: Peter Friedman, MD, PhD
• Email: drfriedman@skincenterderm.com
• Phone: 8453520500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.