Psoriasis Palm & SolesPhase 2/3NCT01765985
Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
A Phase 2/3 study testing PSORIAMED in people with Psoriasis Palm & Soles, run by Pr PASSERON at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Psoriasis Palm & Soles
- What is being tested?
- PSORIAMED
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Sep 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from 18 to 90 year-old with psoriasis on the hands and/or feet diagnosed clinically
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière
Nice, Alpes-Maritimes, 06200
About this study
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.
Read the 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.
- Conditions
- Psoriasis Palm & Soles
- Being tested
- PSORIAMED, PLACEBO
- Keywords
- palmoplantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSORIAMEDDevice
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.
PLACEBODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intercurrent PSORIAMED | Experimental | 5 minutes twice a day for 12 weeks Receives: 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. Receives: Device: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
PASI (Psoriasis Activity Severity Index)
PASI (Psoriasis Activity Severity Index)
Measured: 12 weeks
PGA (Patient global assessment)
PGA (Patient global assessment)
Measured: 12 weeks
NAPSI (Nail Activity Psoriasis Severity Index)
NAPSI (Nail Activity Psoriasis Severity Index)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis Palm & SolesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr PASSERON
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr PASSERON, Association Niçoise Pour la Recherche En Dermatologie
- Investigators
- PASSERON Thierry, Pu-Ph, Principal investigator, ANPRED - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765985
- Sponsor's protocol ID
- 11-CRO-01
- Status last verified
- Jan 2015
- First submitted
- 6 Dec 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current
- ClinicalTrials.gov ID
- NCT01765985
- Acronym / sponsor ID
- 11-CRO-01
- Conditions
- Psoriasis Palm & Soles
- Keywords
- palmoplantar
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pr PASSERONUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercurrent PSORIAMED | Experimental | Device: PSORIAMED5 minutes twice a day for 12 weeks |
| PLACEBO | Active comparator | Device: PLACEBOV0 : 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients from 18 to 90 year-old with psoriasis on the hands and/or feet diagnosed clinically
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSORIAMEDV0 : 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 | Intercurrent PSORIAMED |
| PLACEBOV0 : 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 |
Primary outcome
Test IGA
Time frame: 12 weeks
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.
3 secondary outcomes
PASI (Psoriasis Activity Severity Index)
Time frame: 12 weeks
PGA (Patient global assessment)
Time frame: 12 weeks
NAPSI (Nail Activity Psoriasis Severity Index)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PASSERON Thierry, Pu-Ph principal investigator
ANPRED - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PSORIAMED in people with Psoriasis Palm & Soles, run by Pr PASSERON at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test IGA (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.