Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

Study Overview
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Brief Summary
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Interferential current has shown promising results for treating psoriasis with a good tolerance. Prospective randomized studies versus placebo are required to confirm the interest of such an approach. The Main objective is to assess the efficacy of interferential current for treating palmoplantar psoriasis. Secondary objectives is to assess the subjective efficacy by the patients, the efficacy on the nails, to study the potential side effects.

Detailed Description
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Interferential current has shown promising results for treating psoriasis with a good tolerance. Prospective randomized studies versus placebo are required to confirm the interest of such an approach. Main objective To assess the efficacy of interferential current for treating palmoplantar psoriasis. Secondary objectives To assess the subjective efficacy by the patients, the efficacy on the nails, to study the potential side effects. Patients Patients from 18 to 90 year-old with psoriasis on the hands and/or feet. Length of the study: 12 months Methods Monocentric randomized comparative study versus placebo.Intervention V0 : Selection: Information of the patient, control of inclusion and non inclusion criteria. V1 : Control of inclusion and non inclusion criteria (treatment against psoriasis have to be discontinued for at least 3 weeks and 3 months for anti-IL12/23). Clinical scores and photographs. Explanation of the functioning of the device, then the treatment is followed at home, twice a day 5 minutes. 10% salicylic acid ointment will be applied after each session. V2 : End of the treatment (12 weeks after V1). Clinical scores and photographs. V3 : End of the follow-up (24 weeks after V1). Clinical scores and photographs.

Official Title
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Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

Conditions
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Psoriasis Palm & Soles

Intervention / Treatment
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* Device: PSORIAMED
* Device: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from 18 to 90 year-old with psoriasis on the hands and/or feet diagnosed clinically Exclusion Criteria: Pregnant women, implantable electronic device (such as pace maker), betabloquer. Concomitant use of a treatment potentially active on psoriasis (steroids, vitamin D analogues, immunosuppressive drug, acitretin, cyclosporine, methotrexate, anti-TNF, anti-IL12/IL23).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intercurrent PSORIAMED<br>5 minutes twice a day for 12 weeks | Device: PSORIAMED<br>* V0 : Selection: Information of the patient, control of inclusion and non inclusion criteria. V1 : Control of inclusion and non inclusion criteria (treatment against psoriasis have to be discontinued for at least 3 weeks and 3 months for anti-IL12/23). Clinical scores and photographs. Explanation of the functioning of the device, then the treatment is followed at home, twice a day 5 minutes. 10% salicylic acid ointment will be applied after each session. V2 : End of the treatment (12 weeks after V1). Clinical scores and photographs. V3 : End of the follow-up (24 weeks after V1). Clinical scores and photographs.<br>|
| Active Comparator: PLACEBO<br>V0 : Selection: Information of the patient, control of inclusion and non inclusion criteria. V1 : Control of inclusion and non inclusion criteria (treatment against psoriasis have to be discontinued for at least 3 weeks and 3 months for anti-IL12/23). Clinical scores and photographs. Explanation of the functioning of the device, then the treatment is followed at home, twice a day 5 minutes. 10% salicylic acid ointment will be applied after each session. V2 : End of the treatment (12 weeks after V1). Clinical scores and photographs. V3 : End of the follow-up (24 weeks after V1). Clinical scores and photographs. | Device: PLACEBO<br>* V0 : Selection: Information of the patient, control of inclusion and non inclusion criteria. V1 : Control of inclusion and non inclusion criteria (treatment against psoriasis have to be discontinued for at least 3 weeks and 3 months for anti-IL12/23). Clinical scores and photographs. Explanation of the functioning of the device, then the treatment is followed at home, twice a day 5 minutes. 10% salicylic acid ointment will be applied after each session. V2 : End of the treatment (12 weeks after V1). Clinical scores and photographs. V3 : End of the follow-up (24 weeks after V1). Clinical scores and photographs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test IGA | IGA (investigator Global assessment) score from 0 (healed) to 4 (worst) at 12 and 24 weeks. The criteria of success will be IGA 0 or 1 at W12. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI (Psoriasis Activity Severity Index) | PASI (Psoriasis Activity Severity Index) | 12 weeks | 
| PGA (Patient global assessment) | PGA (Patient global assessment) | 12 weeks | 
| NAPSI (Nail Activity Psoriasis Severity Index) | NAPSI (Nail Activity Psoriasis Severity Index) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palmoplantar