Plantar Warts Clinical Trial
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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