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Comparison of Five Treatments in Patients With Plantar Warts (VRAIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01059110
Recruitment Status : Terminated (Difficulty to enrollment patients)
First Posted : January 29, 2010
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Society of Dermatology and venerology
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE January 29, 2010
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
Complete clinical remission of the warts assessed by the dermatologist [ Time Frame: at 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01059110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Five Treatments in Patients With Plantar Warts
Official Title  ICMJE 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
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Plantar Warts
Intervention  ICMJE
  • Drug: Salicylate ointment
    cream, one application every night, for 90 days
    Other Name: pommade M.O Cochon®
  • Drug: Imiquimod
    cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days
    Other Name: Aldara® 5%
  • Drug: 5-Fluoro-Uracil
    cream, one application every night, during 12 hours, for 90 days
    Other Name: Efudix® 5%
  • Drug: Cryotherapy
    2 cycles of 5 seconds after obtention of halo of white
    Other Name: Liquid nitrogen
Study Arms  ICMJE
  • Experimental: Salicylate ointment
    Salicylate ointment under occlusion (pomade M.O Cochon®)
    Intervention: Drug: Salicylate ointment
  • Experimental: Imiquimod
    Imiquimod : Aldara®
    Intervention: Drug: Imiquimod
  • Experimental: 5-fluoro-uracil
    5-fluoro-uracil cream : Efudix®
    Intervention: Drug: 5-Fluoro-Uracil
  • Experimental: Cryotherapy
    liquid nitrogen : Cryotherapy
    Intervention: Drug: Cryotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 24, 2015)
358
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2010)
780
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01059110
Other Study ID Numbers  ICMJE P070701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Society of Dermatology and venerology
Investigators  ICMJE
Principal Investigator: Olivier CHOSIDOW, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP