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

NCT07545902 | Recruiting

• 1 other identifier: Id 286
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Type Psorisis; Non-pustular Palmoplantar Psoriasis

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

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.

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.

Device: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel

Interventions

PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel DEVICE

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.

Also known as: PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea, PROXERA PSOMED 20 - normalizing cream, 20% urea

Intra-patient Treatment With PROXERA PSOMED 20; Intra-patient Treatment With PROXERA PSOMED 40

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ICIM International S.r.l.: lead

Study Sites (1)

Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio

Chieti, Italia, 66100, Italy

RECRUITING

Central Study Contacts

Paolo Amerio, Professore Ordinario

CONTACT

+ 39 0871358032; paolo.amerio@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)