An interventional study of Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum in Nail Psoriasis, sponsored by ICIM International S.r.l.. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by ICIM International S.r.l. · Not applicable, Interventional, and Treatment
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 21 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →ICIM International S.r.l. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum
Topical medical device in nail cream formulation containing 30% urea, supplied in a 10 mL tube with applicator brush. The product is self-applied by the participant to the assigned target nail twice daily (morning and evening) for 24 weeks. Petrolatum control self-applied by the participant to the contralateral target nail twice daily (morning and evening) for 24 weeks.
Change in Target Nail NAPSI Score From Baseline to Week 24
The NAPSI score is assessed for two contralateral target nails selected at baseline (a device-treated nail and a control nail treated with Vaseline). Each nail is divided into four quadrants and the nail matrix and nail bed are assessed for psoriasis signs, resulting in a total score ranging from 0 to 8 per nail, with higher scores indicating greater severity. The primary analysis compares the change in the NAPSI score of the target nail from baseline to week 24 between the device-treated nail and the control nail. Assessments are performed at baseline and at weeks 4, 12, and 24.
Time frame: Baseline and Week 24
Plan to share: No — Individual participant data will not be made publicly available. Study data are confidential and owned by the Sponsor. Participant data are handled in compliance with applicable data protection laws and are coded/pseudonymized to protect confidentiality. Any publication of study results is subject to Sponsor and Principal Investigator review and approval in accordance with the study publication policy.
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ICIM International S.r.l.