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

Recruiting now · Not applicable

Conditions studied: Plaque Type Psorisis, Non-pustular Palmoplantar Psoriasis

In brief

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.

Key facts

Study ID

NCT07545902

Run by

ICIM International S.r.l.

People needed

35

Starts

2026-04-30

Expected to finish

2026-12-23

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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

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

Where it is running

• Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio — Chieti, Italia, Italy (enrolling)

Full record on ClinicalTrials.gov

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