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

NCT02861404 | Terminated

• 1 other identifier: BIOVRAIE
• Study Type: observational
• Target: 406
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plantar Warts

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• Detection of HPV viral DNA on samples

  research of positive HPV status

  up to Day 90

Secondary Outcomes (4)

• Distribution of viral genotypes

  up to Day 90

• Clinical remission defined

  up to Day 90

• Viral remission for patients with wards resistant to treatments

  up to Day 90

• Clinical relapse

  21 months

Study Arms (5)

Salicylate ointment

patients included in VRAIE study, treated with salicylate ointment (VRAIE study, NCT01059110)

Genetic: skin flakes collection

Imiquimod

patients included in VRAIE study, treated with Imiquimod (VRAIE study, NCT01059110)

Genetic: skin flakes collection

5-Fluoro-Uracil

patients included in VRAIE study, treated with 5-Fluoro-Uracil (VRAIE study, NCT01059110)

Genetic: skin flakes collection

Cryotherapy

patients included in VRAIE study, treated with cryotherapy (VRAIE study, NCT01059110)

Genetic: skin flakes collection

placebo

patients included in VRAIE study, receiving placebo (VRAIE study, NCT01059110)

Genetic: skin flakes collection

Interventions

skin flakes collection GENETIC

viral status assessment of skin flakes

5-Fluoro-Uracil; Cryotherapy; Imiquimod; Salicylate ointment; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Officials

• François Aubin, MD PhD

  Centre Hospitalier Universitaire de Besancon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 10, 2016
• Study Start: April 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share