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.