Clinical trial NCT01765985: Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
Official title: Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Psoriasis Palm & Soles
Keywords: palmoplantar
Lead sponsor: Association Niçoise Pour la Recherche En Dermatologie
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Test IGA
timeFrame: 12 weeks
Secondary outcomes:
measure: PASI (Psoriasis Activity Severity Index)
timeFrame: 12 weeks
measure: PGA (Patient global assessment)
timeFrame: 12 weeks
measure: NAPSI (Nail Activity Psoriasis Severity Index)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière
state: Alpes-Maritimes
Study officials:
affiliation: ANPRED - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
name: PASSERON Thierry, Pu-Ph
role: PRINCIPAL_INVESTIGATOR
References: