Comparison of Five Treatments in Patients With Plantar Warts

Plantar Warts Clinical Trial

— VRAIE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01059110
• Other study ID #: P070701
• Status: Terminated
• Phase: Phase 4
• First received: November 30, 2009
• Last updated: January 10, 2017
• Start date: February 2010
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 358
• Est. completion date: December 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Foot Diseases
• Plantar Warts
• Warts

Intervention

Drug:
• Salicylate ointment
cream, one application every night, for 90 days
• Imiquimod
cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days
• 5-Fluoro-Uracil
cream, one application every night, during 12 hours, for 90 days
• Cryotherapy
2 cycles of 5 seconds after obtention of halo of white

Locations

Country	Name	City	State
France	Medical center	Athis Mons

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Society of Dermatology and venerology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clinical remission of the warts assessed by the dermatologist		at 90 days	No
Secondary	Time remission		at 30, 60 and 90 days	No
Secondary	Number of warts in remission vs baseline		at 30, 60 and 90 days	No
Secondary	Time to first relapse		at 30, 60, 90, 120, 180, 360 and 720 days	No
Secondary	Percentage of relapse (phone call assessment)		at 360 days and 720 days	No
Secondary	Safety		at 90 days	Yes
Secondary	Evaluation of distress (visual analogic scale)		at 90 days	No
Secondary	Compliance.		at 90 days	No