Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

Pr PASSERON

Status and phase: Completed; Phase 3; Phase 2

Conditions: Psoriasis Palm & Soles

Treatments: Device: PLACEBO; Device: PSORIAMED

Study type: Interventional

Funder types: Other

Identifiers

NCT01765985

11-CRO-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Intercurrent PSORIAMED

Experimental group

Description:

5 minutes twice a day for 12 weeks

Treatment:

Device: PSORIAMED

PLACEBO

Active Comparator group

Description:

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.

Treatment:

Device: PLACEBO