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

Study acronym: PASI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 22, 2026 → Nov 25, 2026
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from ICIM International S.r.l.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modifiedv2 Show 6 more changesShow less
    • Recruitment opened
    • Primary completion pushed from Sep 22, 2026 to Nov 25, 2026
    • Study completion pushed from Oct 20, 2026 to Dec 23, 2026
    • Start date changed from estimate of Apr 28, 2026 to Apr 30, 2026
    • Secondary endpoints expanded, about 325 words
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07545902
Lead Sponsor ICIM International S.r.l.
Conditions
(from sponsor)		 Plaque Type Psorisis, Non-pustular Palmoplantar Psoriasis
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov