Non-pustular Palmoplantar Psoriasis, Plaque Type Psorisis
Conditions
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
Brief 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 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.
Interventions
DEVICEPROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
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.
Sponsors
ICIM International S.r.l.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants are informed which target area receives active treatment for self-application purposes. The outcome assessor/evaluator remains blinded to treatment allocation during study assessments.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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: * Psoriasis Area Severity Index (PASI) \<10 * Dermatologic Life Quality Index (DLQI) \<10 * Body Surface Area (BSA) \<10
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4 | Baseline to Week 4 (end of treatment) | 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. |
| Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8 | Baseline to Week 8 (end of treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 8 | Baseline to Week 8 (4 weeks after the end of treatment) | 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. |
| Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 12 | Baseline to Week 12 (4 weeks after the end of treatment) | 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. |
| Change From Baseline in Psoriasis Area and Severity Index Score at Week 4 in the PROXERA PSOMED 20 Cohort | Baseline to Week 4 (end of treatment) | 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. |
| Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 40 Cohort | Baseline to Week 8 (end of treatment) | 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. |
| Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 20 Cohort | Baseline to Week 8 (4 weeks after the end of treatment) | 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. |
| Change From Baseline in Psoriasis Area and Severity Index Score at Week 12 in the PROXERA PSOMED 40 Cohort | Baseline to Week 12 (4 weeks after the end of treatment) | 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. |
| Change From Baseline in Dermatology Life Quality Index Score at Week 4 in the PROXERA PSOMED 20 Cohort | Baseline to Week 4 (end of treatment) | 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. |
| Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 40 Cohort | Baseline to Week 8 (end of treatment) | 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. |
| Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 20 Cohort | Baseline to Week 8 (4 weeks after the end of treatment) | 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. |
| Change From Baseline in Dermatology Life Quality Index Score at Week 12 in the PROXERA PSOMED 40 Cohort | Baseline to Week 12 (4 weeks after the end of treatment) | 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. |
| Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 4 | Baseline to Week 4 (end of treatment) | 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. |
| Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 8 | Baseline to Week 8 (end of treatment) | 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. |
| Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 8 | Baseline to Week 8 (4 weeks after the end of treatment) | 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. |
| Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 12 | Baseline to Week 12 (4 weeks after the end of treatment) | 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. |
| Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 4 | Baseline to Week 4 (end of treatment) | 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. |
| Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 8 | Baseline to Week 8 (4 weeks after the end of treatment) | 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. |
| Number of Participants With One or More Adverse Events in the PROXERA PSOMED 20 Cohort | From first application through Week 8 | 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. |
| Number of Participants With One or More Adverse Events in the PROXERA PSOMED 40 Cohort | From first application through Week 12 | 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. |
Countries
Italy
Contacts
CONTACTPaolo Amerio, Professore Ordinario
Outcome results
None listed