Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-16 @ 2:10 PM
Study NCT ID:
NCT02861404
Status:
TERMINATED
Last Update Posted:
2017-03-03
First Post:
2016-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2016-08-05', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of HPV viral DNA on samples', 'timeFrame': 'up to Day 90', 'description': 'research of positive HPV status'}], 'secondaryOutcomes': [{'measure': 'Distribution of viral genotypes', 'timeFrame': 'up to Day 90', 'description': 'number of samples containing one or more viral type (type 1, 2, 4 or mix)'}, {'measure': 'Clinical remission defined', 'timeFrame': 'up to Day 90', 'description': 'complete remission of wards confirmed by the physician, no later than day 90'}, {'measure': 'Viral remission for patients with wards resistant to treatments', 'timeFrame': 'up to Day 90', 'description': 'viral status modification from negative to positive between day 0 and day 30, day 60 or no more than day 90.'}, {'measure': 'Clinical relapse', 'timeFrame': '21 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HPV'], 'conditions': ['Plantar Warts']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '2000 skin flakes to be collected from patients included in VRAIE study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient aged 18 years or more.\n* Clinical evaluation\n* Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm, whether previously treated or not\n* In treated patients, all potentially active treatment on warts since at least one month should be stopped.\n* Effective contraception for women of childbearing age\n* Immunocompetent patients\n* Patient with one or more warts on soles and board feet.\n\n * 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.\n * Mosaic : plate small warts, superficial, often sitting on the heel or Forefoot. Little painful, they are often ignored by the patients when they appear\n* Patient affiliated to the French social security.viral\n\nExclusion Criteria:\n\n* Patient suspected to be immunocompromised\n* Patient aged under 18 years\n* Patient refusing to sign the consent\n* Pregnant or lactating women\n* Plantar calluses\n* 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)\n* 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)\n* Contra-indication to Pomade M.O Cochon® (Known allergy to any components)\n* Known hypersensitivity to Blenderm®\n* Extra plantar concomitant warts (to exclude risk of endogenous recontamination by an extra plantar site)\n* Plantar hyperhidrosis making impossible adhesion of plaster.'}, 'identificationModule': {'nctId': 'NCT02861404', 'acronym': 'BIOVRAIE', 'briefTitle': 'Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment', 'orgStudyIdInfo': {'id': 'BIOVRAIE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Salicylate ointment', 'description': 'patients included in VRAIE study, treated with salicylate ointment (VRAIE study, NCT01059110)', 'interventionNames': ['Genetic: skin flakes collection']}, {'label': 'Imiquimod', 'description': 'patients included in VRAIE study, treated with Imiquimod (VRAIE study, NCT01059110)', 'interventionNames': ['Genetic: skin flakes collection']}, {'label': '5-Fluoro-Uracil', 'description': 'patients included in VRAIE study, treated with 5-Fluoro-Uracil (VRAIE study, NCT01059110)', 'interventionNames': ['Genetic: skin flakes collection']}, {'label': 'Cryotherapy', 'description': 'patients included in VRAIE study, treated with cryotherapy (VRAIE study, NCT01059110)', 'interventionNames': ['Genetic: skin flakes collection']}, {'label': 'placebo', 'description': 'patients included in VRAIE study, receiving placebo (VRAIE study, NCT01059110)', 'interventionNames': ['Genetic: skin flakes collection']}], 'interventions': [{'name': 'skin flakes collection', 'type': 'GENETIC', 'description': 'viral status assessment of skin flakes', 'armGroupLabels': ['5-Fluoro-Uracil', 'Cryotherapy', 'Imiquimod', 'Salicylate ointment', 'placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'François Aubin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Besancon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}