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

N/ANot Yet RecruitingNCT07545902

ICIM International S.r.l.35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Plaque Type Psorisis Non-pustular Palmoplantar Psoriasis

Interventions

PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gelDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proxera Psomed 20: Change From Baseline in Target Lesion Score at Week 4

Proxera Psomed 20: Target Lesion Score (TLS) is a semi-quantitative clinical score used to assess the severity of a representative psoriatic plaque. Three plaque characteristics are evaluated separately: erythema, induration (thickness), and scaling. Each item is scored from 0 to 4, and the total TLS ranges from 0 to 12, with higher scores indicating more severe disease. The primary analysis compares the change from baseline to Week 4 in the treated target plaque versus the untreated contralateral control area.

Time frame: Proxera Psomed 20: From baseline to end of treatment (4 weeks)

Proxera Psomed 40: Change From Baseline in Modified Palmoplantar Psoriasis Area and Severity Index at Week 8

Proxera Psomed 40: Modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) is a clinical score used to assess the severity of non-pustular palmoplantar psoriasis. The score evaluates erythema, induration, scaling, and extent of involvement in the palmoplantar target area. Higher scores indicate more severe disease. The primary analysis compares the change from baseline to Week 8 in the treated target palm or sole area versus the untreated contralateral control area.

Time frame: Proxera Psomed 40: From baseline to end of treatment (8 weeks)