HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - ADSORBED; HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - ADSORBED for Cutaneous warts (palmar and plantar)

Inclusion criteria

• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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:"}
• {"criterion_text":"- Painful warts (VAS ≥ 4) or functional discomfort (Revised foot function index (RFFI) or Cochin Hand Function Scale (CHSF) or social discomfort (DLQI))."}
• {"criterion_text":"- No systemic immunosuppresive/ immunomodulating drugs"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Individuals affiliated to a social security regimen;"}
• {"criterion_text":"- Individuals able to participate and to follow up during the study period"}

Exclusion criteria

• {"criterion_text":"- Suspicion of COVID, with confirmation by autotest"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Individuals under a measure of legal protection or unable to consent;"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patient on AME (state medical aid) (unless exemption from affiliation)."}
• {"criterion_text":"- Patient wishing to be vaccinated with Gardasil 9® within 6 months (in accordance to the approval of the vaccine) or refusing the principle of postponing vaccination."}
• {"criterion_text":"- Immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days)"}
• {"criterion_text":"- Any causes of immunosupression: organ transplant recipients, bone-marrow transplantation, immunosupressive regimens for any diseases, HIV positivity."}
• {"criterion_text":"- Women or men who received HPV Vaccine previously of the study;"}
• {"criterion_text":"- Any serious chronic or progressive disease according to the judgement of the investigator;"}
• {"criterion_text":"- Individuals with history of known allergies/hypersensitivity to any component of study vaccine;"}
• {"criterion_text":"- Individuals who have any malignancy or lymphoproliferative disorder;"}
• {"criterion_text":"- Individuals with thrombocytopenia or coagulation disorder contre-indicating intramusculary injections;"}
• {"criterion_text":"- Patient with anticoagulant therapy"}
• {"criterion_text":"- Individuals with body temperature > 38.0 degrees Celsius or/and acute disease within 3 days of intended study vaccination;"}

Primary endpoints

• {"endpoint_text":"- Complete remission of cutaneous warts 7 months after the first injection of the vaccine","definition_or_measurement_approach":"Complete remission assessed at 7 months after the first injection of the vaccine (endpoint text as stated)."}

Secondary endpoints

• {"endpoint_text":"- Quality of Life will be evaluated with QoL Questionnaire (DLQI) at M0, M2, M6, M7","definition_or_measurement_approach":"Quality of life measured using DLQI at M0, M2, M6, and M7."}
• {"endpoint_text":"- Pain will be assess using VAS at M0, M2, M6, M7","definition_or_measurement_approach":"Pain assessed using Visual Analogue Scale (VAS) at M0, M2, M6, and M7."}
• {"endpoint_text":"- Functional discomfort for walking and functional disability in hands will be evaluated using the Revised Foot Function index or Cochin hand function scale respectively at M0, M2, M6, M7","definition_or_measurement_approach":"Functional impairment evaluated using Revised Foot Function Index for walking and Cochin Hand Function Scale for hands at M0, M2, M6, and M7."}
• {"endpoint_text":"- Partial remission of cutaneous warts 7 months after the first injection of the vaccine.","definition_or_measurement_approach":"Partial remission assessed at 7 months after the first injection of the vaccine."}
• {"endpoint_text":"- Number of warts appeared at M2, M6, M7","definition_or_measurement_approach":"Count of new warts recorded at visits M2, M6, and M7."}

Methods

• Recruitment arrangements documented (K1_Recruitment arrangements).
• Document titled 'K1_Recruitment arrangement radio_presse' indicates use of radio and press for recruitment (channel: radio, press).
• File naming suggests use of Facebook (digital/social media) in recruitment materials (document filename includes 'radio_presse_fb...').

France

Earliest CTIS Part Ii Submission Date

05-07-2024

Latest Decision Or Authorization Date

16-05-2025

Processing Time Days

315

Number Of Sites

14

Number Of Participants

146

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France