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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of tirbanibulin ointment for treating hand warts in children and teens. A virus causes warts, which are difficult to treat, especially in young people who may not tolerate standard treatments well. The study aims to determine if this ointment offers a good and gentle option. Children aged 8 to 18 with 3 to 10 hand warts, present for no more than 2 years, may qualify for this trial. As a Phase 4 trial, the research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop any over-the-counter, prescription topical, or in-office wart treatments at least 6 weeks before starting the study.

What is the safety track record for tirbanibulin?

Research shows that tirbanibulin ointment is generally easy to use without problems. The FDA has approved it for treating actinic keratosis, a skin condition that appears on the face or scalp. Studies have found that it is well-tolerated, as participants did not stop treatment due to adverse effects. In these studies, no one discontinued use because of side effects.

Some reports suggest that tirbanibulin might be a safe option for treating warts, especially in children. Although specific data on using tirbanibulin for warts is not yet available, its approval for another skin condition provides some confidence in its safety. However, effects can vary, so monitoring during treatment is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for warts, which typically include cryotherapy or salicylic acid, tirbanibulin offers a unique approach with its topical application. This medication works by inhibiting microtubule polymerization, which is a different mechanism of action compared to traditional therapies that focus on physically removing or chemically exfoliating the wart tissue. Researchers are excited about tirbanibulin because it targets the underlying cellular processes directly, potentially leading to more effective and less invasive treatment options for patients.

What evidence suggests that tirbanibulin might be an effective treatment for warts?

Research has shown that tirbanibulin ointment effectively treats skin spots such as actinic keratosis, clearing them completely in 44–54% of patients. Encouraging reports suggest it might also help with warts in children, caused by the human papillomavirus (HPV). In several cases, tirbanibulin completely cleared genital warts after just a few applications. This trial will evaluate tirbanibulin as a topical treatment for warts, indicating it could be a safe and effective option, especially when other treatments aren't suitable for children. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10890708/

Tirbanibulin 1% Ointment for Actinic Keratosis Tirbanibulin efficacy was evaluated in two crucial phase 3 trials, reaching complete clearance in 44–54% of patients and in 76–82% of lesions [ ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06791525

NCT06791525 | Tirbanibulin for Pediatric Warts Study Overview​​ Case reports suggest tirbanibulin ointment may provide an effective and well-tolerated alternative for pediatric warts. This study will evaluate ...

3. mdpi.com mdpi.com/2036-7449/17/3/40

Treatment of Condyloma Acuminata with Tirbanibulin 1% ... Treatment with trichloroacetic acid solution clears 56 to 81 percent of lesions, and 36 percent of lesions recur after clearance [25]. In 2019, Barton et al. [ ...

4. researchgate.net researchgate.net/publication/383269535_Topical_tirbanibulin_ointment_1_as_a_potential_new_treatment_for_recalcitrant_plantar_warts_a_case_report

(PDF) Topical tirbanibulin ointment 1% as a potential new ... Results demonstrated that after 2‐ to 4‐month follow‐up, tirbanibulin was well tolerated and effective in AK patients. Presentations by Dr.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10363664/

Topical tirbanibulin resolves recalcitrant condyloma ... Complete resolution of recalcitrant genital CA with topical tirbanibulin was observed in 5 patients requiring 1 to 5 rounds (Mean, 2; SD, 1.7) of application.

6. go.drugbank.com go.drugbank.com/drugs/DB06137

Tirbanibulin: Uses, Interactions, Mechanism of Action On December 14, 2020, tirbanibulin was approved by the FDA for the topical treatment of actinic keratosis on the face or scalp. It is marketed under the brand ...

7. drugs.com drugs.com/monograph/tirbanibulin-topical.html

Tirbanibulin (Topical) Monograph for Professionals No available data on tirbanibulin use in pregnancy. Animal data indicate potential fetal harm with increased systemic exposure of tirbanibulin.

8. elsevier.es elsevier.es/es-revista-medicina-familia-semergen-40-articulo-tirbanibulin-ointment-a-new-effective-S1138359324000881

Tirbanibulin ointment: A new effective and safe treatment of ... We present tirbanibulin 1% ointment as a potential new therapeutic option that is effective and safe for the treatment of refractory VW.