Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts (NCT04814446) | Clinical Trial Compass
RecruitingPhase 3
Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts
France146 participantsStarted 2022-06-29
Plain-language summary
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.
Who can participate
Age range15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion Criteria:
* 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 progres…