Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis Palm & Soles |
Device: PSORIAMED Device: PLACEBO |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current |
- Test IGA [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- PASI (Psoriasis Activity Severity Index) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]PASI (Psoriasis Activity Severity Index)
- PGA (Patient global assessment) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]PGA (Patient global assessment)
- NAPSI (Nail Activity Psoriasis Severity Index) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]NAPSI (Nail Activity Psoriasis Severity Index)
| Estimated Enrollment: | 36 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intercurrent PSORIAMED
5 minutes twice a day for 12 weeks
|
Device: PSORIAMED
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. |
|
Active Comparator: 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. |
Device: 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. |
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts 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).
Contacts and Locations| Contact: PASSERON Thierry, PU-PH | +33492039224 | thierry.passeron@unice.fr |
| France | |
| ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière | Recruiting |
| Nice, Alpes-Maritimes, France, 06200 | |
| Contact: PASSERON Thierry, PU-PH +33492039224 thierry.passeron@unice.fr | |
| Principal Investigator: PASSEON Thierry, Pu-PH | |
| Principal Investigator: | PASSERON Thierry, Pu-Ph | ANPRED - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice |
More Information
No publications provided
| Responsible Party: | Pr PASSERON, Professor, Association Niçoise Pour la Recherche En Dermatologie |
| ClinicalTrials.gov Identifier: | NCT01765985 History of Changes |
| Other Study ID Numbers: | 11-CRO-01 |
| Study First Received: | December 6, 2012 |
| Last Updated: | January 10, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Association Niçoise Pour la Recherche En Dermatologie:
|
palmoplantar |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Salicylates Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013