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
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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TERMINATED
406 participants
OBSERVATIONAL
2010-04-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Salicylate ointment
patients included in VRAIE study, treated with salicylate ointment (VRAIE study, NCT01059110)
skin flakes collection
viral status assessment of skin flakes
Imiquimod
patients included in VRAIE study, treated with Imiquimod (VRAIE study, NCT01059110)
skin flakes collection
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
viral status assessment of skin flakes
Cryotherapy
patients included in VRAIE study, treated with cryotherapy (VRAIE study, NCT01059110)
skin flakes collection
viral status assessment of skin flakes
placebo
patients included in VRAIE study, receiving placebo (VRAIE study, NCT01059110)
skin flakes collection
viral status assessment of skin flakes
Interventions
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skin flakes collection
viral status assessment of skin flakes
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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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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