NCT02861404终止不适用
Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 406
- 主要终点
- Detection of HPV viral DNA on samples
研究概览
简要总结
The principal objective of the study is the evaluation of the role of Human Papilloma Virus (HPV) in plantar warts (prevalence, genotype), resistant or not, treated or not, cured or not. This epidemiological study is an ancillary study of the prospective, randomized controlled, clinical study VRAIE (sponsor: APHP) comparing 5 usual strategies in the management of plantar warts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient aged 18 years or more.
- •Clinical evaluation
- •Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm, whether previously treated or not
- •In treated patients, all potentially active treatment on warts since at least one month should be stopped.
- •Effective contraception for women of childbearing age
- •Immunocompetent patients
- •Patient with one or more warts on soles and board feet.
- •MYRMECIE : rounded warts, deep, covered with a stratum corneum more or less thick; after stripping, appear black points, very specific; often painful to pressure. They are lonely, single or not. They could regroup galley thick. The stripping can them to individualize.
- •Mosaic : plate small warts, superficial, often sitting on the heel or Forefoot. Little painful, they are often ignored by the patients when they appear
- •Patient affiliated to the French social security.viral
排除标准
- •Patient suspected to be immunocompromised
- •Patient aged under 18 years
- •Patient refusing to sign the consent
- •Pregnant or lactating women
- •Plantar calluses
- •Known hypersensitivity to imiquimod (Aldara®) or any excipients of the cream (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate, propyl hydroxybenzoate, xanthan gum, purified water)
- •Known hypersensitivity to 5 fluoro-uracil (Efudix®) or any excipients of gel (stearyl alcohol, Vaseline, polysorbate 60, propyleneglycol, purified water - conservatives: METHYL PARAHYDROXYBENZOATE, PROPYL PARAHYDROXYBENZOATE)
- •Contra-indication to Pomade M.O Cochon® (Known allergy to any components)
- •Known hypersensitivity to Blenderm®
- •Extra plantar concomitant warts (to exclude risk of endogenous recontamination by an extra plantar site)
- •Plantar hyperhidrosis making impossible adhesion of plaster.
结局指标
主要结局
Detection of HPV viral DNA on samples
时间窗: up to Day 90
research of positive HPV status
次要结局
- Viral remission for patients with wards resistant to treatments(up to Day 90)
- Clinical relapse(21 months)
- Distribution of viral genotypes(up to Day 90)
- Clinical remission defined(up to Day 90)
研究者
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