Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Association Niçoise Pour la Recherche En Dermatologie
Sponsor:
Information provided by (Responsible Party):
Pr PASSERON, Association Niçoise Pour la Recherche En Dermatologie
ClinicalTrials.gov Identifier:
NCT01765985
First received: December 6, 2012
Last updated: January 10, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Association Niçoise Pour la Recherche En Dermatologie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765985

Contacts
Contact: PASSERON Thierry, PU-PH +33492039224 thierry.passeron@unice.fr

Locations
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         
Sponsors and Collaborators
Pr PASSERON
Investigators
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
Salicylic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 22, 2014