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
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Condition or disease | Intervention/treatment |
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Plantar Warts | Genetic: skin flakes collection |
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 |
Group/Cohort | Intervention/treatment |
---|---|
Salicylate ointment
patients included in VRAIE study, treated with salicylate ointment (VRAIE study, NCT01059110)
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Genetic: skin flakes collection
viral status assessment of skin flakes |
Imiquimod
patients included in VRAIE study, treated with Imiquimod (VRAIE study, NCT01059110)
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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)
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Genetic: skin flakes collection
viral status assessment of skin flakes |
placebo
patients included in VRAIE study, receiving placebo (VRAIE study, NCT01059110)
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Genetic: skin flakes collection
viral status assessment of skin flakes |
- Detection of HPV viral DNA on samples [ Time Frame: up to Day 90 ]research of positive HPV status
- 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)
- Clinical remission defined [ Time Frame: up to Day 90 ]complete remission of wards confirmed by the physician, no later than day 90
- 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.
- Clinical relapse [ Time Frame: 21 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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
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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.

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
Principal Investigator: | François Aubin, MD PhD | Centre Hospitalier Universitaire de Besancon |
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 |
HPV |
Warts Foot Diseases Papillomavirus Infections DNA Virus Infections Virus Diseases Infections |
Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Musculoskeletal Diseases |