Informations générales (source: ClinicalTrials.gov)
Efficacy of the Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts (VAC-WARTS)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2022
juin 2026
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | CHANAL Johan | 02/12/2024 12:47:08 | Contacter | ||
| AP-HP - Hôpital Bichat | CHANAL Johan | 02/12/2024 12:47:08 | Contacter | ||
| AP-HP - Hôpital Cochin | CHANAL Johan | 02/12/2024 12:47:08 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | CHANAL Johan | 02/12/2024 12:47:08 | Contacter | ||
| CHI DE CRETEIL | Giao DO PHAM | 06/02/2025 16:28:09 | Contacter | ||
Critères
Tous
Inclusion Criteria:
- Patients of age ≥ 15 years and 3 months with palmar or plantar warts (including
periungueal and back of hands or feet 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 total one month of application of topical salicylic acid, with minimum 3 weeks
continuous.
- At least two sprays of liquid nitrogen (two applications at the same session, or at
different sessions with a few intervals).
- 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.
- Patients of age ≥ 15 years and 3 months with palmar or plantar warts (including
periungueal and back of hands or feet 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 total one month of application of topical salicylic acid, with minimum 3 weeks
continuous.
- At least two sprays of liquid nitrogen (two applications at the same session, or at
different sessions with a few intervals).
- 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.
- Suspicion of COVID, with confirmation by autotest.
- 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.
- Immunosuppressive therapy including use of systemic corticosteroids or chronic
immunosuppressant medication (more than 14 days)