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

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ClinicalTrials.gov Identifier: NCT02861404
Recruitment Status : Terminated
First Posted : August 10, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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.

Condition or disease Intervention/treatment
Plantar Warts Genetic: skin flakes collection

Study Design
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Study Type : Observational
Actual Enrollment : 406 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment
Study Start Date : April 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Groups and Cohorts
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Group/Cohort Intervention/treatment
Salicylate ointment
patients included in VRAIE study, treated with salicylate ointment (VRAIE study, NCT01059110)
 Genetic: skin flakes collection
viral status assessment of skin flakes
Imiquimod
patients included in VRAIE study, treated with Imiquimod (VRAIE study, NCT01059110)
 Genetic: 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)
 Genetic: skin flakes collection
viral status assessment of skin flakes
Cryotherapy
patients included in VRAIE study, treated with cryotherapy (VRAIE study, NCT01059110)
 Genetic: skin flakes collection
viral status assessment of skin flakes
placebo
patients included in VRAIE study, receiving placebo (VRAIE study, NCT01059110)
 Genetic: skin flakes collection
viral status assessment of skin flakes


Outcome Measures
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Primary Outcome Measures :
  1. Detection of HPV viral DNA on samples [ Time Frame: up to Day 90 ]
    research of positive HPV status


Secondary Outcome Measures :
  1. Distribution of viral genotypes [ Time Frame: up to Day 90 ]
    number of samples containing one or more viral type (type 1, 2, 4 or mix)

  2. Clinical remission defined [ Time Frame: up to Day 90 ]
    complete remission of wards confirmed by the physician, no later than day 90

  3. Viral remission for patients with wards resistant to treatments [ Time Frame: up to Day 90 ]
    viral status modification from negative to positive between day 0 and day 30, day 60 or no more than day 90.

  4. Clinical relapse [ Time Frame: 21 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
2000 skin flakes to be collected from patients included in VRAIE study
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861404


Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: François Aubin, MD PhD Centre Hospitalier Universitaire de Besancon
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02861404    
Other Study ID Numbers: BIOVRAIE
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
HPV
Additional relevant MeSH terms:
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Warts
Foot Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
 Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Musculoskeletal Diseases