Plantar WartsPhase 4VRAIENCT01059110
Comparison of Five Treatments in Patients With Plantar Warts
A Phase 4 study testing Salicylate ointment, Imiquimod and 5-Fluoro-Uracil in people with Plantar Warts, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The principal objective of the study is to compare 5 usual strategies in the management of plantar warts which did not cure after 5 weeks of a salicylate ointment given just prior the trial. 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?
- Salicylate ointment, Imiquimod and 5-Fluoro-Uracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Dec 2016
- Phase
- Phase 4
- 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
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.
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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Occlusive Dressings, Salicylate Ointment, Cryotherapy, Topical 5-fluoro-uracil and Imiquimod in Immunocompetent Patients Presenting Plantar Warts in Office-based Settings: a Randomized Clinical Trial
The principal objective of the study is to compare 5 usual strategies in the management of plantar warts which did not cure after 5 weeks of a salicylate ointment given just prior the trial. The trial will include immunocompetent patients coming from the community and should help the office-based dermatologists and hospital in the decision-making therapeutic process.
Read the detailed description
Four and a half million individuals in France have warts (SOFRES poll 2002). Notably, plantar warts are considered to be the most common reason for consulting a private practitioner, despite the absence of robust epidemiological data. Although benign, plantar warts are associated with a certain degree of morbidity: pain, difficulty walking, and intra- and interindividual contagion. Despite the frequency of plantar warts and patients high expectations for their treatments, which are numerous for immunocompetent patients, those remedies have only been evaluated in undeniably inadequate ways. Patient demand for therapy is strong, with those affected going from one physician to another, in the search for the "good treatment". For all the reasons evoked in the context of skin diseases, healing warts can indeed represent a public health objective.
One of the difficulties of evaluating treatments is the frequency of spontaneous complete remissions (natural history) and/or under placebo, assessed at 30% [range: 0-73%] in a short-term trial (10 weeks). In addition, professionals experiences support frequent relapses that have been very poorly evaluated in therapeutic trials.
Keratolytic treatment, usually salicylated petroleum jelly, is the standard therapy according to the Cochrane Review. In practice, this therapy usually combines manual shaving, done by the patient him/herself or the physician. Supplementing this basic therapy with a physical (standard cryotherapy), chemical (5-fluorouracil; Efudix®) or immunological adjunct (imiquimod; Aldara®), to achieve the desired effect of increasing the frequency and/or rapidity of complete cure, has never been examined in a large randomized-controlled trial.
A population comprised of patients with warts still "resistant" after 5 weeks of keratolytic therapy with 50% salicylic acid (PommadeM.O Cochon®) followed by a 1-week washout was deliberately retained because it is this precise setting that poses therapeutic difficulties in routine practice. The 1-week washout will allow the skin to heal a little and facilitate the diagnosis of failures; and, moreover, the strategy of pretreatment with scraping would not be unduly weakened.
- Conditions
- Plantar Warts
- Being tested
- Salicylate ointment, Imiquimod, 5-Fluoro-Uracil, Cryotherapy
- Keywords
- Occlusive dressings, Salicylate ointment, Cryotherapy, Topical 5-fluoro-uracil, Imiquimod, Randomized clinical trial, Plantar warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salicylate ointmentDrug
Also called pommade M.O Cochon®
cream, one application every night, for 90 days
ImiquimodDrug
Also called Aldara® 5%
cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days
5-Fluoro-UracilDrug
Also called Efudix® 5%
cream, one application every night, during 12 hours, for 90 days
CryotherapyDrug
Also called Liquid nitrogen
2 cycles of 5 seconds after obtention of halo of white
| Study group | Role | What they receive |
|---|---|---|
| Salicylate ointment | Experimental | Salicylate ointment under occlusion (pomade M.O Cochon®) Receives: Drug: Salicylate ointment |
| Imiquimod | Experimental | Imiquimod : Aldara® Receives: Drug: Imiquimod |
| 5-fluoro-uracil | Experimental | 5-fluoro-uracil cream : Efudix® Receives: Drug: 5-Fluoro-Uracil |
| Cryotherapy | Experimental | liquid nitrogen : Cryotherapy Receives: Drug: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical remission of the warts assessed by the dermatologist
Measured: at 90 days
Secondary outcomes (7)
Time remission
Measured: at 30, 60 and 90 days
Number of warts in remission vs baseline
Measured: at 30, 60 and 90 days
Time to first relapse
Measured: at 30, 60, 90, 120, 180, 360 and 720 days
Percentage of relapse (phone call assessment)
Measured: at 360 days and 720 days
Safety
Measured: at 90 days
Evaluation of distress (visual analogic scale)
Measured: at 90 days
Compliance.
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2015
- Study completionDec 2016
Why it stopped: Difficulty to enrollment patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar WartsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Dermatology and venerology
- Responsible party
- Sponsor
- Investigators
- Olivier CHOSIDOW, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059110
- Sponsor's protocol ID
- P070701
- Acronym
- VRAIE
- Status last verified
- Jan 2017
- First submitted
- 30 Nov 2009
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chanal J, Aubin F, Penso-Assathiany D, Buffiere I, Makhlouf W, Perriere C, Bocquet H, Aubin A, Farcet Y, Ludmann C, Duboz A, Marco-Bonnet J, Maury C, Tremeau-Martinage C, Hubert-Asso AM, Coustou D, Heudes AM, Kemula M, Beylot-Barry M, Tetart F, Eche-Dejoie A, Duvochel AM, Baspeyras M, Amici JM, Toussaint H, Neculaita L, Mboup B, Pizzi N, Jouis V, Vacher Y, Pretet JL, Vicaut E, Chosidow O. A multicentre pragmatic randomized controlled trial comparing 50% salicylic acid, liquid nitrogen, 5% 5-fluorouracil cream, and 5% imiquimod cream in previously treated plantar warts. The VRAIE (VeRrues plAntaIres en villE) study. Ann Dermatol Venereol. 2025 Sep;152(3):103406. doi: 10.1016/j.annder.2025.103406. Epub 2025 Jul 30.
PubMed 40743833
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Occlusive Dressings, Salicylate Ointment, Cryotherapy, Topical 5-fluoro-uracil and Imiquimod in Immunocompetent Patients Presenting Plantar Warts in Office-based Settings: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01059110
- Acronym / sponsor ID
- VRAIE / P070701
- Conditions
- Plantar Warts
- Keywords
- Occlusive dressings, Salicylate ointment, Cryotherapy, Topical 5-fluoro-uracil, Imiquimod, Randomized clinical trial, Plantar warts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty to enrollment patients
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Society of Dermatology and venerology
- Study start
- Feb 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jan 2010 (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 to compare 5 usual strategies in the management of plantar warts which did not cure after 5 weeks of a salicylate ointment given just prior the trial. The trial will include immunocompetent patients coming from the community and should help the office-based dermatologists and hospital in the decision-making therapeutic process.
Detailed description
Four and a half million individuals in France have warts (SOFRES poll 2002). Notably, plantar warts are considered to be the most common reason for consulting a private practitioner, despite the absence of robust epidemiological data. Although benign, plantar warts are associated with a certain degree of morbidity: pain, difficulty walking, and intra- and interindividual contagion. Despite the frequency of plantar warts and patients high expectations for their treatments, which are numerous for immunocompetent patients, those remedies have only been evaluated in undeniably inadequate ways. Patient demand for therapy is strong, with those affected going from one physician to another, in the search for the "good treatment". For all the reasons evoked in the context of skin diseases, healing warts can indeed represent a public health objective.
One of the difficulties of evaluating treatments is the frequency of spontaneous complete remissions (natural history) and/or under placebo, assessed at 30% [range: 0-73%] in a short-term trial (10 weeks). In addition, professionals experiences support frequent relapses that have been very poorly evaluated in therapeutic trials.
Keratolytic treatment, usually salicylated petroleum jelly, is the standard therapy according to the Cochrane Review. In practice, this therapy usually combines manual shaving, done by the patient him/herself or the physician. Supplementing this basic therapy with a physical (standard cryotherapy), chemical (5-fluorouracil; Efudix®) or immunological adjunct (imiquimod; Aldara®), to achieve the desired effect of increasing the frequency and/or rapidity of complete cure, has never been examined in a large randomized-controlled trial.
A population comprised of patients with warts still "resistant" after 5 weeks of keratolytic therapy with 50% salicylic acid (PommadeM.O Cochon®) followed by a 1-week washout was deliberately retained because it is this precise setting that poses therapeutic difficulties in routine practice. The 1-week washout will allow the skin to heal a little and facilitate the diagnosis of failures; and, moreover, the strategy of pretreatment with scraping would not be unduly weakened.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Salicylate ointment | Experimental | Drug: Salicylate ointmentSalicylate ointment under occlusion (pomade M.O Cochon®) |
| Imiquimod | Experimental | Drug: ImiquimodImiquimod : Aldara® |
| 5-fluoro-uracil | Experimental | Drug: 5-Fluoro-Uracil5-fluoro-uracil cream : Efudix® |
| Cryotherapy | Experimental | Drug: Cryotherapyliquid nitrogen : Cryotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Salicylate ointmentAlso: pommade M.O Cochon®cream, one application every night, for 90 days | Drug | Salicylate ointment |
| ImiquimodAlso: Aldara® 5%cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days | Drug | Imiquimod |
| 5-Fluoro-UracilAlso: Efudix® 5%cream, one application every night, during 12 hours, for 90 days | Drug | 5-fluoro-uracil |
| CryotherapyAlso: Liquid nitrogen2 cycles of 5 seconds after obtention of halo of white | Drug | Cryotherapy |
Primary outcome
Complete clinical remission of the warts assessed by the dermatologist
Time frame: at 90 days
7 secondary outcomes
Time remission
Time frame: at 30, 60 and 90 days
Number of warts in remission vs baseline
Time frame: at 30, 60 and 90 days
Time to first relapse
Time frame: at 30, 60, 90, 120, 180, 360 and 720 days
Percentage of relapse (phone call assessment)
Time frame: at 360 days and 720 days
Safety
Time frame: at 90 days
Evaluation of distress (visual analogic scale)
Time frame: at 90 days
Compliance.
Time frame: at 90 days
Results and safety
The study was stopped early (reason given: Difficulty to enrollment patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 40743833Chanal J, Aubin F, Penso-Assathiany D, Buffiere I, Makhlouf W, Perriere C, Bocquet H, Aubin A, Farcet Y, Ludmann C, Duboz A, Marco-Bonnet J, Maury C, Tremeau-Martinage C, Hubert-Asso AM, Coustou D, Heudes AM, Kemula M, Beylot-Barry M, Tetart F, Eche-Dejoie A, Duvochel AM, Baspeyras M, Amici JM, Toussaint H, Neculaita L, Mboup B, Pizzi N, Jouis V, Vacher Y, Pretet JL, Vicaut E, Chosidow O. A multicentre pragmatic randomized controlled trial comparing 50% salicylic acid, liquid nitrogen, 5% 5-fluorouracil cream, and 5% imiquimod cream in previously treated plantar warts. The VRAIE (VeRrues plAntaIres en villE) study. Ann Dermatol Venereol. 2025 Sep;152(3):103406. doi: 10.1016/j.annder.2025.103406. Epub 2025 Jul 30.
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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.
Olivier CHOSIDOW, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salicylate ointment, Imiquimod and 5-Fluoro-Uracil in people with Plantar Warts, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty to enrollment patients). 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?
Complete clinical remission of the warts assessed by the dermatologist (time frame: at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059110, which also lists 1 linked publication.
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 11 Jan 2017.