Plantar WartsBIOVRAIENCT02861404
Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment
An observational study of Plantar Warts, run by Centre Hospitalier Universitaire de Besancon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Warts
- What is being tested?
- skin flakes collection
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 2000 skin flakes to be collected from patients included in VRAIE study
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
About this study
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
- Being tested
- skin flakes collection
- Keywords
- HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin flakes collectionGenetic
viral status assessment of skin flakes
| Study group | Role | What they receive |
|---|---|---|
| Salicylate ointment | patients included in VRAIE study, treated with salicylate ointment (VRAIE study, NCT01059110) Receives: Genetic: skin flakes collection | |
| Imiquimod | patients included in VRAIE study, treated with Imiquimod (VRAIE study, NCT01059110) Receives: Genetic: skin flakes collection | |
| 5-Fluoro-Uracil | patients included in VRAIE study, treated with 5-Fluoro-Uracil (VRAIE study, NCT01059110) Receives: Genetic: skin flakes collection | |
| Cryotherapy | patients included in VRAIE study, treated with cryotherapy (VRAIE study, NCT01059110) Receives: Genetic: skin flakes collection | |
| placebo | patients included in VRAIE study, receiving placebo (VRAIE study, NCT01059110) Receives: Genetic: skin flakes collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of HPV viral DNA on samples
research of positive HPV status
Measured: up to Day 90
Secondary outcomes (4)
Distribution of viral genotypes
number of samples containing one or more viral type (type 1, 2, 4 or mix)
Measured: up to Day 90
Clinical remission defined
complete remission of wards confirmed by the physician, no later than day 90
Measured: 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.
Measured: up to Day 90
Clinical relapse
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startApr 2010
- Primary completionOct 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar WartsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Aubin, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861404
- Sponsor's protocol ID
- BIOVRAIE
- Acronym
- BIOVRAIE
- Status last verified
- Mar 2017
- First submitted
- 3 Aug 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Viral Status of Patients With Plantar Warts Included in VRAIE Study, Non-responder to Study Treatment
- ClinicalTrials.gov ID
- NCT02861404
- Acronym / sponsor ID
- BIOVRAIE / BIOVRAIE
- Conditions
- Plantar Warts
- Keywords
- HPV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Salicylate ointment | – | Genetic: skin flakes collectionpatients included in VRAIE study, treated with salicylate ointment (VRAIE study, NCT01059110) |
| Imiquimod | – | Genetic: skin flakes collectionpatients included in VRAIE study, treated with Imiquimod (VRAIE study, NCT01059110) |
| 5-Fluoro-Uracil | – | Genetic: skin flakes collectionpatients included in VRAIE study, treated with 5-Fluoro-Uracil (VRAIE study, NCT01059110) |
| Cryotherapy | – | Genetic: skin flakes collectionpatients included in VRAIE study, treated with cryotherapy (VRAIE study, NCT01059110) |
| placebo | – | Genetic: skin flakes collectionpatients included in VRAIE study, receiving placebo (VRAIE study, NCT01059110) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2000 skin flakes to be collected from patients included in VRAIE study
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- Patient suspected to be immunocompromised
- Patient aged under 18 years
- Patient refusing to sign the consent
- Pregnant or lactating women
- Plantar calluses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin flakes collectionviral status assessment of skin flakes | Genetic | 5-Fluoro-Uracil, Cryotherapy, Imiquimod, Salicylate ointment, placebo |
Primary outcome
Detection of HPV viral DNA on samples
Time frame: up to Day 90
research of positive HPV status
4 secondary outcomes
Distribution of viral genotypes
Time frame: up to Day 90
Clinical remission defined
Time frame: up to Day 90
Viral remission for patients with wards resistant to treatments
Time frame: up to Day 90
Clinical relapse
Time frame: 21 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Aubin, MD PhD principal investigator
Centre Hospitalier Universitaire de Besancon
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Warts, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of HPV viral DNA on samples (time frame: up to Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.