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

Condition(s) studied

Investigational drug(s) / intervention(s)

Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum: Topical medical device in nail cream formulation containing 30% urea, supplied in a 10 mL tube with applicator brush. The product is self-applied by the participant to the assigned target nail twice daily (morning and evening) for 24 weeks. Petrolatum control self-applied by the participant to the contralateral target nail twice daily (morning and evening) for 24 weeks.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Target Nail NAPSI Score From Baseline to Week 24 — Baseline and Week 24
  The NAPSI score is assessed for two contralateral target nails selected at baseline (a device-treated nail and a control nail treated with Vaseline). Each nail is divided into four quadrants and the nail matrix and nail bed are assessed for psoriasis signs, resulting in a total score ranging from 0 to 8 per nail, with higher scores indicating greater severity. The primary analysis compares the change in the NAPSI score of the target nail from baseline to week 24 between the device-treated nail and the control nail. Assessments are performed at baseline and at weeks 4, 12, and 24.

Trial sites (1)

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