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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. Identifier: NCT01059110
Recruitment Status : Terminated (Difficulty to enrollment patients)
First Posted : January 29, 2010
Last Update Posted : January 11, 2017
Society of Dermatology and venerology
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Plantar Warts Drug: Salicylate ointment Drug: Imiquimod Drug: 5-Fluoro-Uracil Drug: Cryotherapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: Salicylate ointment
Salicylate ointment under occlusion (pomade M.O Cochon®)
Drug: Salicylate ointment
cream, one application every night, for 90 days
Other Name: pommade M.O Cochon®

Experimental: Imiquimod
Imiquimod : Aldara®
Drug: Imiquimod
cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days
Other Name: Aldara® 5%

Experimental: 5-fluoro-uracil
5-fluoro-uracil cream : Efudix®
Drug: 5-Fluoro-Uracil
cream, one application every night, during 12 hours, for 90 days
Other Name: Efudix® 5%

Experimental: Cryotherapy
liquid nitrogen : Cryotherapy
Drug: Cryotherapy
2 cycles of 5 seconds after obtention of halo of white
Other Name: Liquid nitrogen

Primary Outcome Measures :
  1. Complete clinical remission of the warts assessed by the dermatologist [ Time Frame: at 90 days ]

Secondary Outcome Measures :
  1. Time remission [ Time Frame: at 30, 60 and 90 days ]
  2. Number of warts in remission vs baseline [ Time Frame: at 30, 60 and 90 days ]
  3. Time to first relapse [ Time Frame: at 30, 60, 90, 120, 180, 360 and 720 days ]
  4. Percentage of relapse (phone call assessment) [ Time Frame: at 360 days and 720 days ]
  5. Safety [ Time Frame: at 90 days ]
  6. Evaluation of distress (visual analogic scale) [ Time Frame: at 90 days ]
  7. Compliance. [ Time Frame: at 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059110

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Medical center
Athis Mons, France, 91200
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Society of Dermatology and venerology
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Principal Investigator: Olivier CHOSIDOW, MD,PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01059110    
Other Study ID Numbers: P070701
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Occlusive dressings
Salicylate ointment
Topical 5-fluoro-uracil
Randomized clinical trial
Plantar warts
Additional relevant MeSH terms:
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Foot Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Musculoskeletal Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors