Nail PsoriasisNAPSINCT07546032
Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy
A study of Nail Psoriasis, run by ICIM International S.r.l. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nail Psoriasis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2026to 8 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
Chieti, Italia, 66100
Paolo Amerio, Prof., + 39 0871358032, paolo.amerio@unich.it
About this study
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)
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.
Read more
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.
- Conditions
- Nail Psoriasis
- Being tested
- Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum
- Keywords
- Nail Psoriasis, Psoriasis, PROXERA PSOMED 30, Urea, Topical Medical Device, Intra-patient Controlled Study, Single-Blind Study, Nail Psoriasis Severity Index, Petrolatum
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: PetrolatumDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra-patient PROXERA PSOMED 30 and Petrolatum Control | Experimental | 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. Receives: Device: Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start12 May 2026
- Primary completion8 Feb 2027 (estimated)
- Study completion8 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ICIM International S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546032
- Sponsor's protocol ID
- Id 285
- Acronym
- NAPSI
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07546032
- Acronym / sponsor ID
- NAPSI / Id 285
- Conditions
- Nail Psoriasis
- Keywords
- Nail Psoriasis, Psoriasis, PROXERA PSOMED 30, Urea, Topical Medical Device, Intra-patient Controlled Study, Single-Blind Study, Nail Psoriasis Severity Index
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- ICIM International S.r.l.Industry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- 8 Feb 2027 (estimated)
- Study completion
- 8 Feb 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intra-patient PROXERA PSOMED 30 and Petrolatum Control | Experimental | Device: Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: PetrolatumSingle-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: PetrolatumTopical 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. | Device | Intra-patient PROXERA PSOMED 30 and Petrolatum Control |
Primary outcome
Change in Target Nail NAPSI Score From Baseline to Week 24
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Nail Psoriasis, run by ICIM International S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Amerio, Professore Ordinario (+ 39 0871358032, paolo.amerio@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Target Nail NAPSI Score From Baseline to Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.