Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis (PASI)

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.

Study Overview

• Status: Recruiting
• Conditions: Plaque Type Psorisis; Non-pustular Palmoplantar Psoriasis
• Intervention / Treatment: Device: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Amerio, Professore Ordinario; Phone Number: + 39 0871358032; Email: paolo.amerio@unich.it

Study Locations

• Italy
  • Italia
    • Chieti, Italia, Italy, 66100
      • Recruiting
      • Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
      • Contact: Paolo Amerio, Prof.; Phone Number: + 39 0871358032; Email: paolo.amerio@unich.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-patient Treatment With PROXERA PSOMED 20; 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.	Device: PROXERA 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.; Other Names: PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea; PROXERA PSOMED 20 - normalizing cream, 20% urea
Experimental: Intra-patient Treatment With PROXERA PSOMED 40; 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.	Device: PROXERA 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.; Other Names: PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea; PROXERA PSOMED 20 - normalizing cream, 20% urea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to Week 8 (end of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From first application through Week 12

Collaborators and Investigators

• Sponsor: ICIM International S.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): December 23, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 26, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Psoriasis Area Severity Index; Plaque Psoriasis; Urea; Randomized Study; Single-Blind Study; Topical Medical Device; Intra-patient Controlled Study; Non-Pustular Palmoplantar Psoriasis; PROXERA PSOMED 20; PROXERA PSOMED 40; Target Lesion Score; Dermatologic Life Quality Index; modified Palmoplantar Psoriasis Area Severity Index; Trans Epidermal Water Loss; dermato-capillaroscopy
• Other Study ID Numbers: Id 286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No