Topical PROXERA PSOMED 20 or 40 for psoriasis in adults
Official title: Evaluation of the Efficacy and Safety of the Medical Device PROXERA PSOMED 20 in Reducing Psoriatic Plaques and of the Medical Device PROXERA PSOMED 40 in Reducing Non-pustulous Palmoplantar Psoriasis Flaw in Patients With Plaque Psoriasis: a Sponsored, Interventional, Single-center, Randomized, Single-blind, Intra-patient Controlled Study (PASI)
Run by ICIM International S.r.l. · NCT07545902 · Data updated 2026-11-12
This study tests whether applying PROXERA PSOMED 20 or 40 to a psoriasis-affected area helps more than the untreated area on the same person.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | ICIM International S.r.l. Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Chieti, Italia) |
| Status | Recruiting |
| Started | April 30, 2026 |
| Main results expected | November 25, 2026 |
| Study ends | December 23, 2026 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07545902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults ages 18–65 with mild psoriasis (PASI <10, DLQI <10, BSA <10) and either non-palmoplantar plaque psoriasis or non-pustular palmoplantar psoriasis.
✕Probably not a fit
Patients with more extensive disease, systemic therapy, or intolerance to the study products may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, interventional study evaluates two CE-marked topical devices for psoriasis. PROXERA PSOMED 20 (20% urea) targets non-palmoplantar plaque psoriasis, while PROXERA PSOMED 40 (40% urea) targets non-pustular palmoplantar psoriasis. Each participant applies the assigned device daily to a selected area, with a primary assessment at 4 weeks for the 20% cream and 8 weeks for the 40% gel. Outcomes include safety and tolerability, overall psoriasis progression, quality of life, and local disease activity. The study uses a contralateral control design within each participant to compare treated versus untreated areas.
Why it matters
Potential benefit: If successful, patients could experience improved skin clearance and quality of life from a non-prescription-like topical option.
How similar studies have gone: Use of high-urea topical preparations has shown local skin benefits in psoriasis in other settings, but this exact contralateral-design approach with these devices is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: PROXERA PSOMED 20 - normalizing cream, 20% urea * Diagnosis of plaque psoriasis (not palmoplantar) for at least 1 year PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea * Diagnosis of non-pustular palmoplantar psoriasis for at least 1 year Common inclusion criteria: * Age 18-65 years * "Mild" psoriasis severity according to: * Psoriasis Area Severity Index (PASI) \<10 * Dermatologic Life Quality Index (DLQI) \<10 * Body Surface Area (BSA) \<10 Exclusion Criteria: * Product intolerance * Concomitant therapy with systemic immunomodulatory drugs (e.g., methotrexate, cyclosporine, apremilast) * Concomitant therapy with biologic drugs such as anti-TNFα, anti-IL17, or anti-IL23. * Concomitant topical therapy with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), vitamin D analogues, and combinations. * Pregnant or breastfeeding women
Where it's running
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Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
Chieti, Italia, Italy Recruiting
Study contacts
- Study coordinator: Paolo Amerio, Professore Ordinario
- Email: paolo.amerio@unich.it
- Phone: + 39 0871358032
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Acupuncture with Chinese herbal cream versus acupuncture with calcipotriol for plaque psoriasis
This project will see if acupuncture plus a Chinese herbal cream works as well as acupuncture plus calcipotriol ointment for people with mild plaque psoriasis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.