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

RecruitingNAAges 18 Years - 65 YearsAllICIM International S.r.l.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum
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Where

1 site
Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
Chieti, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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