ClinicalTrials.gg
RecruitingNCT06791525Updated Apr 23, 2026

Tirbanibulin for Pediatric Warts

A Phase 4 interventional study of Tirbanibulin ointment 1% in Warts Hand, sponsored by The Skin Center Dermatology Group. Recruiting at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by The Skin Center Dermatology Group · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
8 Years to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Warts Hand

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In context

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

This study's planned enrollment of 10 is below the median of 70 across 155 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

The Skin Center Dermatology Group is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Topical treatment arm

    Topical medication self-applied

    Drug: Tirbanibulin ointment 1%

Interventions

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What researchers measure

Primary outcomes

  1. Resolution

    Ful resolution of treated lesions

    Time frame: 2 months aftre completion of 4 or less treatment cycles

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Study locations

1 of 1 sites recruiting
  • The Skin Center Dermatology Group
    New City, New York 10956, United States
    Recruiting
    • Eszter Friedman, Clinical Research Coordinator · Contacttrial@skincenterderm.com · 315-616-3706
    • Peter Friedman, Principal Investigator, MD PhD · Principal investigator
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06791525
Lead sponsor
The Skin Center Dermatology Group
Responsible party
Dr. Peter C. Friedman (Principal Investigator, The Skin Center Dermatology Group) — Principal investigator
First posted
Jan 24, 2025
Start date
May 1, 2025
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 23, 2026

Study contacts

Peter Friedman, MD, PhD
Contact
drfriedman@skincenterderm.com
8453520500

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Tirbanibulin

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