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Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy

Study acronym: NAPSI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Dec 8, 2026 → Feb 8, 2027
See other at-risk trials from ICIM International S.r.l.

Record History

  1. Recruitment opened
    • Primary and study completion pushed from Dec 8, 2026 to Feb 8, 2027
    • Start date changed from estimate of Apr 28, 2026 to May 12, 2026
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this interventional clinical study is to evaluate the safety and efficacy of PROXERA PSOMED 30, a topical medical device containing 30% urea, for the treatment of nail psoriasis in adults with nail psoriasis. The primary question the study aims to answer is whether PROXERA PSOMED 30 improves the clinical signs of nail psoriasis more effectively than a control treatment (Vaseline). Researchers will compare two similar target nails in the same participant, one treated with PROXERA PSOMED 30 and the other with Vaseline, to determine whether the active treatment leads to greater improvement in Nail Psoriasis Severity Index (NAPSI) scores over 24 weeks. The study will also evaluate local tolerability, patient satisfaction, and digital photographs of the treated nails. Participants will be men or women between the ages of 18 and 65 with nail psoriasis for at least 6 months and a target NAPSI nail score of 3 or higher. A total of 21 participants is expected. Participants will: apply PROXERA PSOMED 30 to one target nail and petroleum jelly to the opposite target nail twice daily for 24 weeks; attend follow-up visits at baseline and after 4, 12, and 24 weeks; undergo nail assessments using the NAPSI score; have digital photographs of treated nails; report tolerability, satisfaction, and any adverse events during the study.
Trial Details
NCT Number NCT07546032
Lead Sponsor ICIM International S.r.l.
Conditions
(from sponsor)		 Nail Psoriasis
Related terms Psoriasis
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov