Topical Proxera PSOMED 30 for Nail Psoriasis
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)
Run by ICIM International S.r.l. · NCT07546032 · Data updated 2026-11-12
A topical cream with 30% urea is being tested on adults with nail psoriasis to see if it improves nail symptoms better than plain petrolatum over 24 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 21 (estimated) |
| Sponsor | ICIM International S.r.l. Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Chieti, Italia) |
| Status | Recruiting |
| Started | May 12, 2026 |
| Main results expected | February 8, 2027 |
| Study ends | February 8, 2027 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07546032 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-65 with a confirmed diagnosis of nail psoriasis for at least 6 months and a NAPSI nail score of 3 or higher.
✕Probably not a fit
Participants with hypersensitivity to any component of the product or those using incompatible systemic or biologic therapies may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares PROXERA PSOMED 30 nail cream to petrolatum in adults with nail psoriasis. Each participant applies the active product to one target nail and the petrolatum to a comparable nail on the same person, allowing a direct within-subject comparison of nail psoriasis severity over 24 weeks. Outcomes include changes in Nail Psoriasis Severity Index (NAPSI), local tolerability, patient satisfaction, and serial digital photos. Eligible participants are adults 18-65 with nail psoriasis for at least 6 months and a NAPSI nail score of 3 or higher; about 21 participants are planned. The lead sponsor is ICIM International S.r.l., and the study is conducted at the Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D’Annunzio in Chieti, Italy.
Why it matters
Potential benefit: If successful, participants could see improved nail symptoms and satisfaction with a topical treatment containing 30% urea.
How similar studies have gone: Previous studies in topical therapies for nail psoriasis have shown variable improvements, and this approach with a high-urea formulation is exploratory but grounded in topical dermatologic care.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
Chieti, Italia, Italy Recruiting
Study contacts
- Study coordinator: Paolo Amerio, Professore Ordinario
- Email: paolo.amerio@unich.it
- Phone: + 39 0871358032
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Roflumilast 0.3% Cream for chronic plaque psoriasis and nail psoriasis
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Topical PROXERA PSOMED 20 or 40 for psoriasis in adults
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.