Psoriasis Palm & Soles
Conditions
Keywords
palmoplantar
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.
Interventions
DEVICEPSORIAMED
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.
DEVICEPLACEBO
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.
Sponsors
Pr PASSERON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| PASI (Psoriasis Activity Severity Index) | 12 weeks | PASI (Psoriasis Activity Severity Index) |
| PGA (Patient global assessment) | 12 weeks | PGA (Patient global assessment) |
| NAPSI (Nail Activity Psoriasis Severity Index) | 12 weeks | NAPSI (Nail Activity Psoriasis Severity Index) |
Countries
France
Outcome results
None listed