Clinical trial NCT02861404: Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment
Official title: Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Plantar Warts
Keywords: HPV
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2000 skin flakes to be collected from patients included in VRAIE study

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Detection of HPV viral DNA on samples
timeFrame: up to Day 90
Secondary outcomes:
measure: Distribution of viral genotypes
timeFrame: up to Day 90
measure: Clinical remission defined
timeFrame: up to Day 90
measure: Viral remission for patients with wards resistant to treatments
timeFrame: up to Day 90
measure: Clinical relapse
timeFrame: 21 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: François Aubin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: