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

Who is this study for? Patients with Palmar or Plantar Warts
What treatments are being studied? Vaccination
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hospital Cochin
RECRUITING
Paris
Contact Information
Primary
Johan CHANAL, Dr
johan.chanal@aphp.fr
+33 1 58 41 18 25
Backup
Olivier CHOSIDOW, Pr
olivier.chosidow@aphp.fr
+33 1 49 81 21 11
Time Frame
Start Date: 2022-06-29
Estimated Completion Date: 2026-06-29
Participants
Target number of participants: 146
Treatments
Experimental: Gardasil 9®
Nonavalent HPV vaccine
Placebo_comparator: Placebo
NaCl 0.9 % solution for injection
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov