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Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

Primary Purpose

Psoriasis Palm & Soles

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
PSORIAMED
PLACEBO
Sponsored by
Pr PASSERON
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Palm & Soles focused on measuring palmoplantar

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intercurrent PSORIAMED

PLACEBO

Arm Description

5 minutes twice a day for 12 weeks

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PASI (Psoriasis Activity Severity Index)
PASI (Psoriasis Activity Severity Index)
PGA (Patient global assessment)
PGA (Patient global assessment)
NAPSI (Nail Activity Psoriasis Severity Index)
NAPSI (Nail Activity Psoriasis Severity Index)

Full Information

First Posted
December 6, 2012
Last Updated
January 13, 2015
Sponsor
Pr PASSERON
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1. Study Identification

Unique Protocol Identification Number
NCT01765985
Brief Title
Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
Official Title
Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pr PASSERON

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Palm & Soles
Keywords
palmoplantar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intercurrent PSORIAMED
Arm Type
Experimental
Arm Description
5 minutes twice a day for 12 weeks
Arm Title
PLACEBO
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PSORIAMED
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PLACEBO
Intervention Description
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 Measure Information:
Title
Test IGA
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PASI (Psoriasis Activity Severity Index)
Description
PASI (Psoriasis Activity Severity Index)
Time Frame
12 weeks
Title
PGA (Patient global assessment)
Description
PGA (Patient global assessment)
Time Frame
12 weeks
Title
NAPSI (Nail Activity Psoriasis Severity Index)
Description
NAPSI (Nail Activity Psoriasis Severity Index)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PASSERON Thierry, Pu-Ph
Organizational Affiliation
ANPRED - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

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Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

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