Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

Psoriasis Palm & Soles Clinical Trial

Official title:

Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765985
• Other study ID #: 11-CRO-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 6, 2012
• Last updated: January 13, 2015
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: January 2015
• Source: Association Niçoise Pour la Recherche En Dermatologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Palm & Soles

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Pr PASSERON

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test IGA	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.	12 weeks	No
Secondary	PASI (Psoriasis Activity Severity Index)	PASI (Psoriasis Activity Severity Index)	12 weeks	No
Secondary	PGA (Patient global assessment)	PGA (Patient global assessment)	12 weeks	No
Secondary	NAPSI (Nail Activity Psoriasis Severity Index)	NAPSI (Nail Activity Psoriasis Severity Index)	12 weeks	No