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

Condition(s) studied

Investigational drug(s) / intervention(s)

PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4 — Baseline to Week 4 (end of treatment)
  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.
• Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8 — Baseline to Week 8 (end of treatment)
  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.

Trial sites (1)

More ICIM International S.r.l. trials in Italy