NCT07546032Recruiting
Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy
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)
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 15 Apr 2026
- Start date
- 12 May 2026
- Primary completion date
- 8 Feb 2027
- Lead sponsor
- ICIM International S.r.l.
- Diseases
- Psoriasis
- NCT number
- NCT07546032
What you commit to
- Study type: Interventional
- Planned participants: 21
- From 12 May 2026 to the primary completion date, 8 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known hypersensitivity or intolerance to any component of the product.
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio Coordinator of this site? Confirm its status | Chieti | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.