Efficacy of the nonavalent HPV vaccine in the treatment of difficult-to-treat palmo-plantar warts
- Conditions
- Vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts in patients of more than 15 years and 3 months of ageTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-000333-13-FR
- Lead Sponsor
- APHP DRCI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Patients of age = 15 years and 3 months with palmar or plantar warts since more than one year with:
- = 5 warts (X palmar and X plantar) or
- = 4 cm2 of Total surface involved by the warts
(Y cm x Z cm).
- Patients should have received two lines of treatment during the past year before inclusion, the last treatment must be at 3 weeks maximum before inclusion:
-At least one months of application of topical salicylic acid
-At least two sprays of liquid nitrogen
- Painful warts (VAS = 4) or functional discomfort (Revised foot function index (RFFI) or Cochin Hand Function Scale (CHSF) or social discomfort (DLQI)).
- No topical or systemic immunosuppresive/ immunomodulating drugs
- Women of childbearing potential must have a negative pregnancy test and an effective contraception (V1) and up the end of the vaccination period of 6 months;
- Individuals affiliated to a social security regimen;
- Individuals able to participate and to follow up during the study period.
Are the trial subjects under 18? yes
Number of subjects for this age range: 146
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Recent (under 72 hours) Positive Covid test (PCR)
- Any causes of immunosupression: organ transplant recipients, bone-marrow transplantation, immunosupressive regimens for any diseases, HIV positivity.
- Women or men who received HPV Vaccine previously of the study;
- Any serious chronic or progressive disease according to the judgement of the investigator;
- Individuals with history of known allergies/hypersensitivity to any component of study vaccine;
- Individuals who have any malignancy or lymphoproliferative disorder;
- Individuals with thrombocytopenia or coagulation disorder contre-indicating intramusculary injections;
- Patient with anticoagulant therapy
- Individuals with body temperature > 38.0 degrees Celsius or/and acute disease within 3 days of intended study vaccination;
- Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, during the first 6 months ½ of the study;
- Individuals under a measure of legal protection or unable to consent;
- Individuals participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of the study.
- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
- Patient on AME (state medical aid) (unless exemption from affiliation).
- Patient wishing to be vaccinated with Gardasil 9® within 6 months or refusing the principle of postponing vaccination.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to evaluate if the nonavalent HPV vaccine, as compared to placebo, clears difficult-to-treat palmar or plantar warts (failure of two treatments before inclusion) one month after the third injection in immunocompetent patients;Secondary Objective: To assess the improvement of quality-of-life<br>To assess the improvement of pain <br>To assess the improvement for walking and hand impairment<br>;Primary end point(s): Complete remission of cutaneous warts 7 months after the first injection of the vaccine
- Secondary Outcome Measures
Name Time Method