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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Society of Dermatology and venerology
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01059110
First received: November 30, 2009
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 in the decision-making therapeutic process.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Complete clinical remission of the warts assessed by the dermatologist [ Time Frame: at 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time remission [ Time Frame: at 30, 60 and 90 days ] [ Designated as safety issue: No ]
  • Number of warts in remission vs baseline [ Time Frame: at 30, 60 and 90 days ] [ Designated as safety issue: No ]
  • Time to first relapse [ Time Frame: at 30, 60, 90, 120, 180, 360 and 720 days ] [ Designated as safety issue: No ]
  • Percentage of relapse (phone call assessment) [ Time Frame: at 360 days and 720 days ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: at 90 days ] [ Designated as safety issue: Yes ]
  • Evaluation of distress (visual analogic scale) [ Time Frame: at 90 days ] [ Designated as safety issue: No ]
  • Compliance. [ Time Frame: at 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: February 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059110

Contacts
Contact: NA

Locations
France
Medical center Recruiting
Athis Mons, France, 91200
Contact: Yolaine FARCET, Dr    +33(0(1 60 48 15 29    yo19@wanadoo.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Society of Dermatology and venerology
Investigators
Principal Investigator: Olivier CHOSIDOW, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01059110     History of Changes
Other Study ID Numbers: P070701
Study First Received: November 30, 2009
Last Updated: November 12, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Occlusive dressings
Salicylate ointment
Cryotherapy
Topical 5-fluoro-uracil
Imiquimod
Randomized clinical trial
Plantar warts

Additional relevant MeSH terms:
Foot Diseases
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases
Musculoskeletal Diseases
Imiquimod
Fluorouracil
Salicylates
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014