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

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.

Study Overview

• Status: Terminated
• Conditions: Plantar Warts
• Intervention / Treatment: Genetic: skin flakes collection

• Study Type: Observational
• Enrollment (Actual): 406

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

2000 skin flakes to be collected from patients included in VRAIE study

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of HPV viral DNA on samples	research of positive HPV status	up to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of viral genotypes	number of samples containing one or more viral type (type 1, 2, 4 or mix)	up to Day 90
Clinical remission defined	complete remission of wards confirmed by the physician, no later than day 90	up to Day 90
Viral remission for patients with wards resistant to treatments	viral status modification from negative to positive between day 0 and day 30, day 60 or no more than day 90.	up to Day 90
Clinical relapse		21 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: François Aubin, MD PhD, Centre Hospitalier Universitaire de Besançon

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: HPV
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Foot Diseases
• Other Study ID Numbers: BIOVRAIE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No