Actively Recruiting
Efficacy of the Nonavalent HPV Vaccine for Treating Difficult-to-treat Palmo-plantar Warts A Randomized, Double-Blind Study Assessing Complete Remission and Quality of Life
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 common skin growths caused by various types of human papilloma virus (HPV), especially types 1, 2, 4, 27, and 57, which frequently affect the palms and soles. This research aims to evaluate whether the nonavalent HPV vaccine can lead to complete remission in patients aged 15 years and 3 months or older who have difficult-to-treat palmo-plantar warts lasting more than one year. Previous case reports and reviews suggest that HPV vaccines might be effective, but clinical trials are needed to confirm this.
CONDITIONS
Official Title
Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts
Who Can Participate
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Hospital Cochin
Paris, France, 75014
Actively Recruiting
Research Team
J
Johan CHANAL, Dr
O
Olivier CHOSIDOW, Pr
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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