Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
- Conditions
- Psoriasis Palm & Soles
- Interventions
- Device: PSORIAMEDDevice: PLACEBO
- Registration Number
- NCT01765985
- Lead Sponsor
- Pr PASSERON
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Patients from 18 to 90 year-old with psoriasis on the hands and/or feet diagnosed clinically
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intercurrent PSORIAMED PSORIAMED 5 minutes twice a day for 12 weeks PLACEBO PLACEBO 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 Outcome Measures
Name Time Method Test IGA 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 Outcome Measures
Name Time Method PGA (Patient global assessment) 12 weeks PGA (Patient global assessment)
PASI (Psoriasis Activity Severity Index) 12 weeks PASI (Psoriasis Activity Severity Index)
NAPSI (Nail Activity Psoriasis Severity Index) 12 weeks NAPSI (Nail Activity Psoriasis Severity Index)
Trial Locations
- Locations (1)
ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière
🇫🇷Nice, Alpes-Maritimes, France