Skin Products for Plaque Psoriasis and Psoriasis on Palms and Soles
Tests two skin products on psoriasis patches, compared with untreated skin, in adults.
Key facts
- Who runs it
- ICIM International S.r.l.
- Where
- Chieti, ItalySee the site
- Trial code
- Registry title
- Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis
- Status
- Recruiting
- People taking part
- 35 people, planned
- Started
- 30 Apr 2026
- Expected to end
- 23 Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
- 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 aged 18-65 with mild plaque psoriasis or mild non-pustular psoriasis of the palms and soles. Two skin products with urea are tested.
- Age
- 18 to 65 years
- Sex
- All sexes can join
- Disease stage
- Mild psoriasis: PASI below 10, DLQI below 10 and BSA below 10. Plaque psoriasis (not on palms or soles) for the cream, or non-pustular palmoplantar psoriasis for the gel, diagnosed at least 1 year ago.
- Earlier treatment
- Cannot be using systemic immune-modifying drugs, biologic drugs, or topical corticosteroids, calcineurin inhibitors or vitamin D products at the same time.
Main reasons for not taking part
- Intolerance to the product
- Taking systemic immune-modifying drugs such as methotrexate, cyclosporine or apremilast
- Taking biologic drugs such as anti-TNFα, anti-IL17 or anti-IL23
- Using topical corticosteroids, calcineurin inhibitors or vitamin D analogues
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Product intolerance
- 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
This single-center interventional study was designed to evaluate the efficacy and safety of two CE-marked topical medical devices: PROXERA PSOMED 20 is being studied in participants with non-palmoplantar plaque psoriasis, while PROXERA PSOMED 40 is being studied in participants with non-pustular palmoplantar psoriasis.
Read full original descriptionShow less
The study aims to determine whether treating a target area with the assigned medical device leads to greater clinical improvement compared to the untreated contralateral control area in the same participant. For PROXERA PSOMED 20, the primary assessment is performed after 4 weeks of treatment. For PROXERA PSOMED 40, the primary assessment is performed after 8 weeks of treatment.
Secondary objectives include the assessment of safety, local tolerability, overall psoriasis progress, its impact on quality of life, and additional parameters of local disease activity at the target areas. Participants will apply the assigned study device once daily to the selected target area, undergo clinical assessments at scheduled visits, and provide safety and tolerability information throughout the study.
The 2 groups in the trial
- Intra-patient Treatment With PROXERA PSOMED 20Treatment being tested
Single-group, randomized, single-blind, intra-patient controlled study arm. Participants are assigned to treatment according to diagnosis: participants with non-palmoplantar plaque psoriasis receive PROXERA PSOMED 20 once daily for 4 weeks on one target plaque, while participants with non-pustular palmoplantar psoriasis receive PROXERA PSOMED 40 once daily for 8 weeks on one target palm or sole area. In both cohorts, a comparable contralateral target area remains untreated as control. For PROXERA PSOMED 40, treatment is interrupted for 3 days every 14 days.
Treatment: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
- Intra-patient Treatment With PROXERA PSOMED 40Treatment being tested
Participants with non-pustular palmoplantar psoriasis self-apply PROXERA PSOMED 40 once daily at the same time of day to one target palm or sole area for 8 weeks. The dose is applied according to the fingertip unit rule. A comparable contralateral target area remains untreated as control. Treatment is interrupted for 3 days every 14 days.
Treatment: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
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 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)
- Plain-language title
- Skin Products for Plaque Psoriasis and Psoriasis on Palms and SolesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07545902, who can take part
- Record updated
- 28 July 2026