Clinical Trial: Comparison of Five Treatments in Patients With Plantar Warts

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 C

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 Summary:

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 "res
Sponsor: Assistance Publique - Hôpitaux de Paris

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: November 30, 2009
Date Started: February 2010
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017