Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evalu… (NCT07546032) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy
Italy21 participantsStarted 2026-04-28
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Target Nail NAPSI Score From Baseline to Week 24