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| Name | Class |
|---|---|
| Society of Dermatology and venerology | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salicylate ointment | Experimental | Salicylate ointment under occlusion (pomade M.O Cochon®) |
|
| Imiquimod | Experimental | Imiquimod : Aldara® |
|
| 5-fluoro-uracil | Experimental | 5-fluoro-uracil cream : Efudix® |
|
| Cryotherapy | Experimental | liquid nitrogen : Cryotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salicylate ointment | Drug | cream, one application every night, for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete clinical remission of the warts assessed by the dermatologist | at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
Patient affiliated to the French social security.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier CHOSIDOW, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical center | Athis-Mons | 91200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40743833 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Imiquimod | Drug | cream, one dose of 250 mg, one application 3 times a week during 12 hours, for 90 days |
|
|
| 5-Fluoro-Uracil | Drug | cream, one application every night, during 12 hours, for 90 days |
|
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| Cryotherapy | Drug | 2 cycles of 5 seconds after obtention of halo of white |
|
|
| 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 |
| Evaluation of distress (visual analogic scale) | at 90 days |
| Compliance. | at 90 days |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |