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Completed

NCT Number: NCT01765985

Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière

Nice, Alpes-Maritimes, 06200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PSORIAMED

Device

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.

PLACEBO

Device

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.

Primary outcomes

  1. Test IGA

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. PASI (Psoriasis Activity Severity Index)

    Time frame: 12 weeks

    PASI (Psoriasis Activity Severity Index)

  2. PGA (Patient global assessment)

    Time frame: 12 weeks

    PGA (Patient global assessment)

  3. NAPSI (Nail Activity Psoriasis Severity Index)

    Time frame: 12 weeks

    NAPSI (Nail Activity Psoriasis Severity Index)

Sponsors and collaborators

Lead sponsor

Pr PASSERON

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.