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

Plantar Warts Clinical Trial

— BIOVRAIE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02861404
• Other study ID #: BIOVRAIE
• Status: Terminated
• Phase: N/A
• First received: August 3, 2016
• Last updated: March 1, 2017
• Start date: April 2010
• Est. completion date: June 2016

Study information

• Verified date: March 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 406
• Est. completion date: June 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Foot Diseases
• Plantar Warts
• Warts

Intervention

Genetic:
• skin flakes collection
viral status assessment of skin flakes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of HPV viral DNA on samples	research of positive HPV status	up to Day 90
Secondary	Distribution of viral genotypes	number of samples containing one or more viral type (type 1, 2, 4 or mix)	up to Day 90
Secondary	Clinical remission defined	complete remission of wards confirmed by the physician, no later than day 90	up to Day 90
Secondary	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
Secondary	Clinical relapse		21 months