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Klinisk studie på medisinske enheter PROXERA PSOMED 20 og PROXERA PSOMED 40 for behandling av plakkpsoriasis og ikke-pustulær palmoplantar psoriasis (PASI)

26. juli 2026 oppdatert av: ICIM International S.r.l.

Evaluering av effektiviteten og sikkerheten til medisinsk utstyr PROXERA PSOMED 20 for reduksjon av psoriatiske plater og medisinsk utstyr PROXERA PSOMED 40 for reduksjon av ikke-pustuløs palmoplantar psoriasisflaw hos pasienter med plakkpsoriasis: en sponset, intervensjonell, enkelt-senter, randomisert, enkelt-blind, intra-pasientkontrollert studie (PASI)

Denne enkelt-senter intervensjonsstudien ble designet for å evaluere effektiviteten og sikkerheten til to CE-merket topiske medisinske enheter: PROXERA PSOMED 20 studeres i deltakere med ikke-palmoplantar plaque psoriasis, mens PROXERA PSOMED 40 studeres i deltakere med ikke-pustulær palmoplantar psoriasis.

Studien har som mål å fastslå om behandling av et målområde med den tildelte medisinske enheten fører til større klinisk forbedring sammenlignet med det ubehandlede kontralaterale kontrollområdet hos samme deltaker. For PROXERA PSOMED 20 utføres primærvurderingen etter 4 ukers behandling. For PROXERA PSOMED 40 utføres primærvurderingen etter 8 ukers behandling.

Sekundære mål inkluderer vurdering av sikkerhet, lokal tolerabilitet, generell psoriasisprogresjon, dens innvirkning på livskvalitet, og ytterligere parametere for lokal sykdomsaktivitet i målområdene. Deltakerne vil påføre den tildelte studieenheten en gang daglig på det utvalgte målområdet, gjennomgå kliniske vurderinger ved planlagte besøk, og gi informasjon om sikkerhet og tolerabilitet gjennom hele studien.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

35

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Italia
    • Italia
      • Chieti, Italia, Italia, 66100
        • Rekruttering
        • Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

PROXERA PSOMED 20 - normaliserende krem, 20% urea

  • Diagnose med plaque psoriasis (ikke palmoplantar) i minst 1 år PROXERA PSOMED 40 - intensiv eksfolierende gel, 40% urea
  • Diagnose med ikke-pustulær palmoplantar psoriasis i minst 1 år

Felles inklusjonskriterier:

  • Alder 18-65 år
  • "Mild" psoriasis alvorlighetsgrad i henhold til:
  • Psoriasis Area Severity Index (PASI) <10
  • Dermatologic Life Quality Index (DLQI) <10
  • Body Surface Area (BSA) <10

Eksklusjonskriterier:

  • Produktintoleranse
  • Samtidig behandling med systemiske immunmodulerende legemidler (f.eks. metotreksat, cyklosporin, apremilast)
  • Samtidig behandling med biologiske legemidler som anti-TNFα, anti-IL17 eller anti-IL23.
  • Samtidig lokalbehandling med topikale kortikosteroider (TCS), topikale calcineurinhemmere (TCI), vitamin D-analoger og kombinasjoner.
  • Gravide eller ammende kvinner

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intrapasientbehandling med PROXERA PSOMED 20
Enkeltgruppe, randomisert, enkeltblind, intra-pasient kontrollert studiearm. Deltakere tildeles behandling i henhold til diagnose: deltakere med ikke-palmoplantar plakkpsoriasis mottar PROXERA PSOMED 20 én gang daglig i 4 uker på én målt plakk, mens deltakere med ikke-pustulær palmoplantar psoriasis mottar PROXERA PSOMED 40 én gang daglig i 8 uker på ett målt håndflate- eller fotsåleområde. I begge kohortene forblir et sammenlignbart kontralateralt målt område ubehandlet som kontroll. For PROXERA PSOMED 40 avbrytes behandlingen i 3 dager hver 14. dag.
Enhet: PROXERA PSOMED 20 krem; PROXERA PSOMED 40 gel

Proxera Psomed 20: Medisinsk topikalt produkt i kremformulering som inneholder 20% urea, levert i en tube på 200 mL. Dette påføres av deltakeren selv en gang daglig på samme tidspunkt på dagen på det valgte målflekken i 4 uker, i henhold til fingertuppenhetsregelen. Den kontralaterale sammenlignbare målflekken forblir ubehandlet som kontroll.

Proxera Psomed 40: Medisinsk topikalt produkt i gelformulering som inneholder 40% urea, levert i en tube på 100 mL. Dette påføres av deltakeren selv en gang daglig på samme tidspunkt på dagen på det valgte målområdet på håndflaten eller fotsålen i 8 uker, i henhold til fingertuppenhetsregelen. Behandlingen avbrytes i 3 dager hver 14. dag. Den kontralaterale sammenlignbare målflekken forblir ubehandlet som kontroll.

Andre navn:
  • PROXERA PSOMED 40 - intensiv eksfolierende gel, 40% urea
  • PROXERA PSOMED 20 - normaliserende krem, 20% urea
Eksperimentell: Intrapasientbehandling med PROXERA PSOMED 40
Deltakere med ikke-pustulær palmoplantar psoriase påfører selv PROXERA PSOMED 40 en gang daglig på samme tidspunkt hver dag til ett målområde på håndflaten eller fotsålen i 8 uker. Dosen påføres i henhold til fingertuppeenhetsregelen. Et sammenlignbart kontralateralt målområde forblir ubehandlet som kontroll. Behandlingen avbrytes i 3 dager hver 14. dag.
Enhet: PROXERA PSOMED 20 krem; PROXERA PSOMED 40 gel

Proxera Psomed 20: Medisinsk topikalt produkt i kremformulering som inneholder 20% urea, levert i en tube på 200 mL. Dette påføres av deltakeren selv en gang daglig på samme tidspunkt på dagen på det valgte målflekken i 4 uker, i henhold til fingertuppenhetsregelen. Den kontralaterale sammenlignbare målflekken forblir ubehandlet som kontroll.

Proxera Psomed 40: Medisinsk topikalt produkt i gelformulering som inneholder 40% urea, levert i en tube på 100 mL. Dette påføres av deltakeren selv en gang daglig på samme tidspunkt på dagen på det valgte målområdet på håndflaten eller fotsålen i 8 uker, i henhold til fingertuppenhetsregelen. Behandlingen avbrytes i 3 dager hver 14. dag. Den kontralaterale sammenlignbare målflekken forblir ubehandlet som kontroll.

Andre navn:
  • PROXERA PSOMED 40 - intensiv eksfolierende gel, 40% urea
  • PROXERA PSOMED 20 - normaliserende krem, 20% urea

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4
Tidsramme: Baseline to Week 4 (end of treatment)
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling. Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity. In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 4 in the treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8
Tidsramme: Baseline to Week 8 (end of treatment)
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area. Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6. For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease. In participants treated with PROXERA PSOMED 40, the primary analysis compares the change from baseline to Week 8 in the treated target area with the change in the contralateral untreated control area.
Baseline to Week 8 (end of treatment)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 8
Tidsramme: Baseline to Week 8 (4 weeks after the end of treatment)
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling. Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity. In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 8 in the treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 8 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 12
Tidsramme: Baseline to Week 12 (4 weeks after the end of treatment)
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area. Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6. For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease. In participants treated with PROXERA PSOMED 40, the outcome compares the change from baseline to Week 12 in the treated target area with the change in the contralateral untreated control area.
Baseline to Week 12 (4 weeks after the end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
Tidsramme: Baseline to Week 4 (end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 4 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20. The assessment is used to determine whether changes observed in the target plaque occur independently of, or in parallel with, changes in overall psoriasis severity.
Baseline to Week 4 (end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
Tidsramme: Baseline to Week 8 (end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 8 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40. The assessment is used to determine whether changes observed in the target palm or sole area occur independently of, or in parallel with, changes in overall psoriasis severity.
Baseline to Week 8 (end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
Tidsramme: Baseline to Week 8 (4 weeks after the end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 8 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20. The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
Tidsramme: Baseline to Week 12 (4 weeks after the end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 12 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40. The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
Tidsramme: Baseline to Week 4 (end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 4 in participants treated with PROXERA PSOMED 20.
Baseline to Week 4 (end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
Tidsramme: Baseline to Week 8 (end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 40.
Baseline to Week 8 (end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
Tidsramme: Baseline to Week 8 (4 weeks after the end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
Tidsramme: Baseline to Week 12 (4 weeks after the end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 12 in participants treated with PROXERA PSOMED 40, 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 4
Tidsramme: Baseline to Week 4 (end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 4 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 8
Tidsramme: Baseline to Week 8 (end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area.
Baseline to Week 8 (end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 8
Tidsramme: Baseline to Week 8 (4 weeks after the end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 12
Tidsramme: Baseline to Week 12 (4 weeks after the end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 12 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area, 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 4
Tidsramme: Baseline to Week 4 (end of treatment)
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque. This outcome compares the change in vascular density from baseline to Week 4 between the two target plaques in participants treated with PROXERA PSOMED 20.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 8
Tidsramme: Baseline to Week 8 (4 weeks after the end of treatment)
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque. This outcome compares the change in vascular density from baseline to Week 8 between the two target plaques in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 20 Cohort
Tidsramme: From first application through Week 8
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator. Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis. The outcome is the number and proportion of participants experiencing at least one adverse event.
From first application through Week 8
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 40 Cohort
Tidsramme: From first application through Week 12
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator. Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis. The outcome is the number and proportion of participants experiencing at least one adverse event.
From first application through Week 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ICIM International S.r.l.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. april 2026

Primær fullføring (Antatt)

25. november 2026

Studiet fullført (Antatt)

23. desember 2026

Datoer for studieregistrering

Først innsendt

16. april 2026

Først innsendt som oppfylte QC-kriteriene

16. april 2026

Først lagt ut (Faktiske)

22. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • Id 286

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individuelle deltakerdata vil ikke bli gjort offentlig tilgjengelig.
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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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