Nail Psoriasis
Conditions
Keywords
Nail Psoriasis, Psoriasis, PROXERA PSOMED 30, Urea, Topical Medical Device, Intra-patient Controlled Study, Single-Blind Study, Nail Psoriasis Severity Index, Petrolatum
Brief 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.
Interventions
DEVICEDevice 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.
Sponsors
ICIM International S.r.l.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an intra-patient controlled study. Participants are informed which target nail receives active treatment and which receives petrolatum control for self-application. The outcome assessor/evaluator is blinded to treatment allocation during study assessments.
Intervention model description
This is a randomized, single-blind, intra-patient controlled study. For each participant, two contralateral target nails with comparable nail psoriasis severity are selected at baseline. One target nail is randomized to receive PROXERA PSOMED 30 and the opposite target nail is randomized to receive petrolatum as control. Both treatments are self-applied twice daily for 24 weeks. The evaluator remains blinded to treatment allocation, and each participant serves as his or her own control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Target Nail NAPSI Score From Baseline to Week 24 | Baseline and 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. |
Countries
Italy
Contacts
CONTACTPaolo Amerio, Professore Ordinario
Outcome results
None listed