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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

Phase 4
18 Years
Open (Enrolling)
Plantar Warts

Thank you

Trial Information

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

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.

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:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete clinical remission of the warts assessed by the dermatologist

Outcome Time Frame:

at 90 days

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

February 2010

Completion Date:

April 2015

Related Keywords:

  • Plantar Warts
  • Occlusive dressings
  • Salicylate ointment
  • Cryotherapy
  • Topical 5-fluoro-uracil
  • Imiquimod
  • Randomized clinical trial
  • Plantar warts
  • Warts
  • Foot Diseases