2024-513671-40-00招募中3 期
VAC-WARTS Efficacy of the nonavalent HPV vaccine in the treatment of difficult-to-treat palmo-plantar warts
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 10
- 主要终点
- Complete remission of cutaneous warts 7 months after the first injection of the vaccine
研究概览
简要总结
The main objective is to evaluate if the nonavalent HPV vaccine, as compared to placebo, conduct to complete remission of difficult-to-treat palmar or plantar warts (failure of two treatments before inclusion) one month after the third injection in immunocompetent patients.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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:
- •Painful warts (VAS ≥ 4) or functional discomfort (Revised foot function index (RFFI) or Cochin Hand Function Scale (CHSF) or social discomfort (DLQI)).
- •No 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
排除标准
- •Suspicion of COVID, with confirmation by autotest
- •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 (in accordance to the approval of the vaccine) or refusing the principle of postponing vaccination.
- •Immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days)
- •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;
结局指标
主要结局
Complete remission of cutaneous warts 7 months after the first injection of the vaccine
Complete remission of cutaneous warts 7 months after the first injection of the vaccine
次要结局
- Quality of Life will be evaluated with QoL Questionnaire (DLQI) at M0, M2, M6, M7
- Pain will be assess using VAS at M0, M2, M6, M7
- 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
- Partial remission of cutaneous warts 7 months after the first injection of the vaccine.
- Number of warts appeared at M2, M6, M7
研究者
Coordinating Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (10)
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