Plaque Type PsorisisPASINCT07545902
Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis
A study testing PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel in people with Plaque Type Psorisis and Non-pustular Palmoplantar Psoriasis, run by ICIM International S.r.l. at 1 site in Italy.
Trial summary
This single-center interventional study was designed to evaluate the efficacy and safety of two CE-marked topical medical devices: PROXERA PSOMED 20 is being studied in participants with non-palmoplantar plaque psoriasis, while PROXERA PSOMED 40 is being studied in participants with non-pustular palmoplantar… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Type Psorisis, Non-pustular Palmoplantar Psoriasis
- What is being tested?
- PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2026to 23 Dec 2026
- Phase
- Interventional
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PROXERA PSOMED 20 - normalizing cream, 20% urea
- Diagnosis of plaque psoriasis (not palmoplantar) for at least 1 year PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea
- Diagnosis of non-pustular palmoplantar psoriasis for at least 1 year
- Common inclusion criteria:
- Age 18-65 years
- "Mild" psoriasis severity according to:
Show all 9Show fewer
- Psoriasis Area Severity Index (PASI) <10
- Dermatologic Life Quality Index (DLQI) <10
- Body Surface Area (BSA) <10
Who cannot join
- Product intolerance
- Concomitant therapy with systemic immunomodulatory drugs (e.g., methotrexate, cyclosporine, apremilast)
- Concomitant therapy with biologic drugs such as anti-TNFα, anti-IL17, or anti-IL23.
- Concomitant topical therapy with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), vitamin D analogues, and combinations.
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
Chieti, Italia, 66100
Paolo Amerio, Prof., + 39 0871358032, paolo.amerio@unich.it
About this study
Official title: Evaluation of the Efficacy and Safety of the Medical Device PROXERA PSOMED 20 in Reducing Psoriatic Plaques and of the Medical Device PROXERA PSOMED 40 in Reducing Non-pustulous Palmoplantar Psoriasis Flaw in Patients With Plaque Psoriasis: a Sponsored, Interventional, Single-center, Randomized, Single-blind, Intra-patient Controlled Study (PASI)
This single-center interventional study was designed to evaluate the efficacy and safety of two CE-marked topical medical devices: PROXERA PSOMED 20 is being studied in participants with non-palmoplantar plaque psoriasis, while PROXERA PSOMED 40 is being studied in participants with non-pustular palmoplantar psoriasis.
The study aims to determine whether treating a target area with the assigned medical device leads to greater clinical improvement compared to the untreated contralateral control area in the same participant. For PROXERA PSOMED 20, the primary assessment is performed after 4 weeks of treatment. For PROXERA PSOMED 40, the primary assessment is performed after 8 weeks of treatment.
Secondary objectives include the assessment of safety, local tolerability, overall psoriasis progress, its impact on quality of life, and additional parameters of local disease activity at the target areas. Participants will apply the assigned study device once daily to the selected target area, undergo clinical assessments at scheduled visits, and provide safety and tolerability information throughout the study.
- Being tested
- PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
- Keywords
- Plaque Psoriasis, Non-Pustular Palmoplantar Psoriasis, PROXERA PSOMED 20, PROXERA PSOMED 40, Urea, Topical Medical Device, Intra-patient Controlled Study, Randomized Study, Single-Blind Study, Psoriasis Area Severity Index, Target Lesion Score, Dermatologic Life Quality Index, modified Palmoplantar Psoriasis Area Severity Index, Trans Epidermal Water Loss, dermato-capillaroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gelDevice
Also called PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea, PROXERA PSOMED 20 - normalizing cream, 20% urea
Proxera Psomed 20: Topical medical device in cream formulation containing 20% urea, supplied in a 200 mL tube. It is self-applied by the participant once daily at the same time of day to the selected target plaque for 4 weeks, according to the fingertip unit rule. The contralateral comparable target area remains untreated as control.
Proxera Psomed 40: Topical medical device in gel formulation containing 40% urea, supplied in a 100 mL tube. It is self-applied by the participant once daily at the same time of day to the selected target palm or sole area for 8 weeks, according to the fingertip unit rule. Treatment is interrupted for 3 days every 14 days. The contralateral comparable target area remains untreated as control.
| Study group | Role | What they receive |
|---|---|---|
| Intra-patient Treatment With PROXERA PSOMED 20 | Experimental | Single-group, randomized, single-blind, intra-patient controlled study arm. Participants are assigned to treatment according to diagnosis: participants with non-palmoplantar plaque psoriasis receive PROXERA PSOMED 20 once daily for 4 weeks on one target plaque, while participants with non-pustular palmoplantar psoriasis receive PROXERA PSOMED 40 once daily for 8 weeks on one target palm or sole area. In both cohorts, a comparable contralateral target area remains untreated as control. For PROXERA PSOMED 40, treatment is interrupted for 3 days every 14 days. Receives: Device: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel |
| Intra-patient Treatment With PROXERA PSOMED 40 | Experimental | Participants with non-pustular palmoplantar psoriasis self-apply PROXERA PSOMED 40 once daily at the same time of day to one target palm or sole area for 8 weeks. The dose is applied according to the fingertip unit rule. A comparable contralateral target area remains untreated as control. Treatment is interrupted for 3 days every 14 days. Receives: Device: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling. Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity. In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 4 in the treated target plaque with the change in the contralateral untreated control plaque.
Measured: Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area. Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6. For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease. In participants treated with PROXERA PSOMED 40, the primary analysis compares the change from baseline to Week 8 in the treated target area with the change in the contralateral untreated control area.
Measured: Baseline to Week 8 (end of treatment)
Secondary outcomes (18)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 8
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling. Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity. In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 8 in the treated target plaque with the change in the contralateral untreated control plaque.
Measured: Baseline to Week 8 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 12
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area. Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6. For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease. In participants treated with PROXERA PSOMED 40, the outcome compares the change from baseline to Week 12 in the treated target area with the change in the contralateral untreated control area.
Measured: Baseline to Week 12 (4 weeks after the end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 4 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20. The assessment is used to determine whether changes observed in the target plaque occur independently of, or in parallel with, changes in overall psoriasis severity.
Measured: Baseline to Week 4 (end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 8 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40. The assessment is used to determine whether changes observed in the target palm or sole area occur independently of, or in parallel with, changes in overall psoriasis severity.
Measured: Baseline to Week 8 (end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 8 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20. The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
Measured: Baseline to Week 8 (4 weeks after the end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 12 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40. The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
Measured: Baseline to Week 12 (4 weeks after the end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 4 in participants treated with PROXERA PSOMED 20.
Measured: Baseline to Week 4 (end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 40.
Measured: Baseline to Week 8 (end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
Measured: Baseline to Week 8 (4 weeks after the end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 12 in participants treated with PROXERA PSOMED 40, 4 weeks after the end of treatment.
Measured: Baseline to Week 12 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 4
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 4 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque.
Measured: Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 8
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area.
Measured: Baseline to Week 8 (end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 8
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque, 4 weeks after the end of treatment.
Measured: Baseline to Week 8 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 12
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 12 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area, 4 weeks after the end of treatment.
Measured: Baseline to Week 12 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 4
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque. This outcome compares the change in vascular density from baseline to Week 4 between the two target plaques in participants treated with PROXERA PSOMED 20.
Measured: Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 8
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque. This outcome compares the change in vascular density from baseline to Week 8 between the two target plaques in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
Measured: Baseline to Week 8 (4 weeks after the end of treatment)
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 20 Cohort
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator. Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis. The outcome is the number and proportion of participants experiencing at least one adverse event.
Measured: From first application through Week 8
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 40 Cohort
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator. Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis. The outcome is the number and proportion of participants experiencing at least one adverse event.
Measured: From first application through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start30 Apr 2026
- Primary completion25 Nov 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Type PsorisisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, single-blind, intra-patient controlled study. Participants are assigned to treatment based on diagnosis: participants with non-palmoplantar plaque psoriasis receive PROXERA PSOMED 20, while participants with non-pustular palmoplantar psoriasis receive PROXERA PSOMED 40. Some patients (estimated 10-15%) may be eligible for both treatments if they have both conditions. Within each cohort, two comparable contralateral target areas are identified at baseline; one target area is assigned to treatment and the contralateral area remains untreated as a control. The outcome assessor remains blinded to treatment assignment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ICIM International S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545902
- Sponsor's protocol ID
- Id 286
- Acronym
- PASI
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Study data are confidential and owned by the Sponsor. Participant data are handled in compliance with applicable data protection laws and are coded to protect confidentiality. Any publication of study results is subject to Sponsor and Principal Investigator review and approval in accordance with the study publication policy.