Nail cream tested against petroleum jelly for nail psoriasis in adults
Tests a urea nail cream against petroleum jelly in adults with nail psoriasis.
Key facts
- Who runs it
- ICIM International S.r.l.
- Where
- Chieti, ItalySee the site
- Trial code
- Registry title
- Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy
- Status
- Recruiting
- People taking part
- 21 people, planned
- Started
- 12 May 2026
- Expected to end
- 8 Feb 2027
- Type of study
- Interventional
- Treatments tested
- Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum
- Record updated
- 28 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with nail psoriasis for at least 6 months. It tests a urea nail cream against Vaseline on two similar nails.
- Age
- 18 to 65 years
- Sex
- Men and women can join.
- Disease stage
- Psoriasis with nail psoriasis for at least 6 months, with a nail severity score (NAPSI) of 3 or higher.
- Earlier treatment
- People cannot be using certain medicines at the same time: systemic immunomodulatory drugs (except methotrexate), biologic drugs, or topical steroids and similar skin creams.
Main reasons for not taking part
- Known allergy or intolerance to any component of the product
- Taking systemic immunomodulatory drugs such as cyclosporine or apremilast (methotrexate is allowed)
- Taking biologic drugs such as anti-TNFα, anti-IL17 or anti-IL23
- Using topical steroids, calcineurin inhibitors, vitamin D analogues or combinations
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Known hypersensitivity or intolerance to any component of the product
- Pregnant or breastfeeding women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Italy
- Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' AnnunzioChieti, ItalyContact: Paolo Amerio, Prof.Taking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The group in the trial
- Intra-patient PROXERA PSOMED 30 and Petrolatum ControlTreatment being tested
Single-group, randomized, single-blind, intra-patient controlled study arm. Each participant has two contralateral target nails with comparable nail psoriasis severity selected at baseline. One target nail is randomized to receive PROXERA PSOMED 30 nail cream (30% urea), and the opposite target nail is randomized to receive petrolatum as control. Treatments are self-applied twice daily (morning and evening) for 24 weeks.
Treatment: Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Plain-language title
- Nail cream tested against petroleum jelly for nail psoriasis in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07546032, who can take part
- Record updated
- 28 July 2026