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

Official title

Evaluation of the Safety and Efficacy of the Medical Device PROXERA PSOMED 30 in the Treatment of Nail Psoriasis: a Sponsored, Interventional, Single-center, Randomized, Single-site, Intrapatient Controlled Study (NAPSI)

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.

Interventions

• Device 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.

Primary outcome measures

• Change in Target Nail NAPSI Score From Baseline to Week 24 [Time frame: Baseline and Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. — Chieti

Identifiers

NCT: NCT07546032 · Id 285

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗