Comparison of Five Treatments in Patients With Plantar Warts

NCT01059110 | Terminated Phase 4 DMC

• 1 other identifier: P070701
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Warts

Keywords

Occlusive dressings; Salicylate ointment; Cryotherapy; Topical 5-fluoro-uracil; Imiquimod; Randomized clinical trial; Plantar warts

Outcome Measures

Primary Outcomes (1)

• Complete clinical remission of the warts assessed by the dermatologist

  at 90 days

Secondary Outcomes (7)

• Time remission

  at 30, 60 and 90 days

• Number of warts in remission vs baseline

  at 30, 60 and 90 days

• Time to first relapse

  at 30, 60, 90, 120, 180, 360 and 720 days

• Percentage of relapse (phone call assessment)

  at 360 days and 720 days

• Safety

  at 90 days

Study Arms (4)

Salicylate ointment

EXPERIMENTAL

Salicylate ointment under occlusion (pomade M.O Cochon®)

Drug: Salicylate ointment

Imiquimod

EXPERIMENTAL

Imiquimod : Aldara®

Drug: Imiquimod

5-fluoro-uracil

EXPERIMENTAL

5-fluoro-uracil cream : Efudix®

Drug: 5-Fluoro-Uracil

Cryotherapy

EXPERIMENTAL

liquid nitrogen : Cryotherapy

Drug: Cryotherapy

Interventions

Salicylate ointment DRUG

cream, one application every night, for 90 days

Also known as: pommade M.O Cochon®

Salicylate ointment

Imiquimod DRUG

cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days

Also known as: Aldara® 5%

Imiquimod

5-Fluoro-Uracil DRUG

cream, one application every night, during 12 hours, for 90 days

Also known as: Efudix® 5%

5-fluoro-uracil

Cryotherapy DRUG

2 cycles of 5 seconds after obtention of halo of white

Also known as: Liquid nitrogen

Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Society of Dermatology and venerology: collaborator

Study Sites (1)

Medical center

Athis-Mons, 91200, France

Location

Related Publications (1)

• Chanal J, Aubin F, Penso-Assathiany D, Buffiere I, Makhlouf W, Perriere C, Bocquet H, Aubin A, Farcet Y, Ludmann C, Duboz A, Marco-Bonnet J, Maury C, Tremeau-Martinage C, Hubert-Asso AM, Coustou D, Heudes AM, Kemula M, Beylot-Barry M, Tetart F, Eche-Dejoie A, Duvochel AM, Baspeyras M, Amici JM, Toussaint H, Neculaita L, Mboup B, Pizzi N, Jouis V, Vacher Y, Pretet JL, Vicaut E, Chosidow O. A multicentre pragmatic randomized controlled trial comparing 50% salicylic acid, liquid nitrogen, 5% 5-fluorouracil cream, and 5% imiquimod cream in previously treated plantar warts. The VRAIE (VeRrues plAntaIres en villE) study. Ann Dermatol Venereol. 2025 Sep;152(3):103406. doi: 10.1016/j.annder.2025.103406. Epub 2025 Jul 30.

  PMID: 40743833 DERIVED

MeSH Terms

Interventions

Imiquimod; Cryotherapy

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Olivier CHOSIDOW, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: January 29, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

FR (1)