Comparison of Five Treatments in Patients With Plantar Warts (VRAIE)
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 in the decision-making therapeutic process.
Drug: Salicylate ointment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Complete clinical remission of the warts assessed by the dermatologist [ Time Frame: at 90 days ] [ Designated as safety issue: No ]
- Time remission [ Time Frame: at 30, 60 and 90 days ] [ Designated as safety issue: No ]
- Number of warts in remission vs baseline [ Time Frame: at 30, 60 and 90 days ] [ Designated as safety issue: No ]
- Time to first relapse [ Time Frame: at 30, 60, 90, 120, 180, 360 and 720 days ] [ Designated as safety issue: No ]
- Percentage of relapse (phone call assessment) [ Time Frame: at 360 days and 720 days ] [ Designated as safety issue: No ]
- Safety [ Time Frame: at 90 days ] [ Designated as safety issue: Yes ]
- Evaluation of distress (visual analogic scale) [ Time Frame: at 90 days ] [ Designated as safety issue: No ]
- Compliance. [ Time Frame: at 90 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Salicylate ointment
Salicylate ointment under occlusion (pomade M.O Cochon®)
Drug: Salicylate ointment
cream, one application every night, for 90 days
Other Name: pommade M.O Cochon®
Imiquimod : Aldara®
cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days
Other Name: Aldara® 5%
5-fluoro-uracil cream : Efudix®
cream, one application every night, during 12 hours, for 90 days
Other Name: Efudix® 5%
liquid nitrogen : Cryotherapy
2 cycles of 5 seconds after obtention of halo of white
Other Name: Liquid nitrogen
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.
|Athis Mons, France, 91200|
|Contact: Yolaine FARCET, Dr +33(0(1 60 48 15 29 email@example.com|
|Principal Investigator:||Olivier CHOSIDOW, MD,PhD||Assistance Publique - Hôpitaux de Paris|