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.
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
Psoriasis Area Severity Index (PASI) <10
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.
Parallel
PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
DeviceProxera 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.
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.
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.
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