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

ICIM International S.r.l.21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nail Psoriasis

Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: PetrolatumDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Psoriasis * Diagnosis of nail psoriasis for at least 6 months (NAPSI ≥ 3) * Male or female * Age between 18 and 65 years * Willingness to participate in the study and signing the informed consent form Exclusion Criteria: * Known hypersensitivity or intolerance to any component of the product. * Concomitant therapy with systemic immunomodulatory drugs (e.g., cyclosporine, apremilast), except methotrexate (MTX), the use of which will be compatible with the study. * Concomitant therapy with biologic agents such as anti-TNFα, anti-IL17, or anti-IL23. * Concomitant topical therapy with topical steroids (TCS), topical calcineurin inhibitors (TCI), vitamin D analogues, and combinations. * Pregnant or breastfeeding women

Outcomes

Primary Outcomes

Change in Target Nail NAPSI Score From Baseline to 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.

Time frame: Baseline and Week 24

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts