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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Besancon

Current Primary Outcome: Detection of HPV viral DNA on samples [ Time Frame: up to Day 90 ]

research of positive HPV status


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Besancon

Dates:
Date Received: August 3, 2016
Date Started: April 2010
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017