Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

NCT01765985 | Completed Phase 2

• 1 other identifier: 11-CRO-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Palm & Soles

Keywords

palmoplantar

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• PASI (Psoriasis Activity Severity Index)

  12 weeks

• PGA (Patient global assessment)

  12 weeks

• NAPSI (Nail Activity Psoriasis Severity Index)

  12 weeks

Study Arms (2)

Intercurrent PSORIAMED

EXPERIMENTAL

5 minutes twice a day for 12 weeks

Device: PSORIAMED

PLACEBO

ACTIVE COMPARATOR

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

Interventions

PSORIAMED DEVICE

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.

Intercurrent PSORIAMED

PLACEBO DEVICE

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from 18 to 90 year-old with psoriasis on the hands and/or feet diagnosed clinically

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pr PASSERON: lead

Study Sites (1)

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

Nice, Alpes-Maritimes, 06200, France

Location

Study Officials

• PASSERON Thierry, Pu-Ph

  ANPRED - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: January 11, 2013
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

FR (1)