Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment

NCT ID: NCT02861404

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

406 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Plantar Warts

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Salicylate ointment

patients included in VRAIE study, treated with salicylate ointment (VRAIE study, NCT01059110)

skin flakes collection

Intervention Type GENETIC

viral status assessment of skin flakes

Imiquimod

patients included in VRAIE study, treated with Imiquimod (VRAIE study, NCT01059110)

skin flakes collection

Intervention Type GENETIC

viral status assessment of skin flakes

5-Fluoro-Uracil

patients included in VRAIE study, treated with 5-Fluoro-Uracil (VRAIE study, NCT01059110)

skin flakes collection

Intervention Type GENETIC

viral status assessment of skin flakes

Cryotherapy

patients included in VRAIE study, treated with cryotherapy (VRAIE study, NCT01059110)

skin flakes collection

Intervention Type GENETIC

viral status assessment of skin flakes

placebo

patients included in VRAIE study, receiving placebo (VRAIE study, NCT01059110)

skin flakes collection

Intervention Type GENETIC

viral status assessment of skin flakes

Interventions

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skin flakes collection

viral status assessment of skin flakes

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Aubin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Other Identifiers

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BIOVRAIE

Identifier Type: -

Identifier Source: org_study_id

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