Actively Recruiting

Phase 3
Age: 15Years +
All Genders
NCT04814446

Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-23

146

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cutaneous viral warts are very common and are caused by the human papilloma virus (HPV). Most people experience warts in one form or another at some point in their lives. Cutaneous warts are related to different types of HPV. For the palms and soles, HPV 2 has been the most frequently found but HPV 1, 4, 27, and 57 have also been described. Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.

CONDITIONS

Official Title

Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 15 years and 3 months or older with palmar or plantar warts (including periungueal and back of hands or feet) lasting more than one year
  • Having at least 5 warts or at least 4 cm2 total surface area affected by warts
  • Patients must have received two types of treatment in the past year, including at least one month of topical salicylic acid (minimum 3 weeks continuous) and at least two applications of liquid nitrogen
  • Warts cause pain (VAS score 4 or higher), functional discomfort, or social discomfort
  • No use of topical or systemic immunosuppressive or immunomodulating drugs
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study
  • Participants must be affiliated with social security and able to participate and follow up during the study
Not Eligible

You will not qualify if you...

  • Suspected COVID infection confirmed by autotest
  • Any immunosuppression, including organ or bone marrow transplant, immunosuppressive treatments, or HIV positivity
  • Previous HPV vaccination
  • Serious chronic or progressive diseases as judged by the investigator
  • Known allergies or hypersensitivity to any component of the study vaccine
  • Any malignancy or lymphoproliferative disorder
  • Thrombocytopenia or coagulation disorders preventing intramuscular injections
  • Use of anticoagulant therapy
  • Body temperature above 38.0°C or acute illness within 3 days before vaccination
  • Pregnancy, breastfeeding, or lack of acceptable birth control in women of childbearing age during the first 6.5 months of study
  • Individuals under legal protection or unable to consent
  • Participation in another clinical trial within 28 days before study start or planned participation during the study
  • Patients on state medical aid unless exempted
  • Patients wishing to be vaccinated with Gardasil 9® within 6 months or refusing to postpone vaccination
  • Use of systemic corticosteroids or chronic immunosuppressive medication for more than 14 days prior to study enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Cochin

Paris, France, 75014

Actively Recruiting

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Research Team

J

Johan CHANAL, Dr

CONTACT

O

Olivier CHOSIDOW, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts | DecenTrialz