Sammenligning af mekaniske penetrationsforstærkere på Metvixia hudpenetration
10. april 2026 opdateret af: Galderma R&D
Eksplorativ undersøgelse for at sammenligne mekaniske penetrationsforstærkere på Metvixia hudpenetration
Udforskende, mono-center, randomiseret, intra-individuelt, kontrolleret forsøg, der involverer raske frivillige for at sammenligne effekten på MAL-penetration i huden efter forskellige mekaniske penetrationsforstærkningsteknikker.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Ved baseline blev hver mini-zone udvalgt og tilfældigt tildelt en forbehandling: 3 zoner med microneedling Dermaroller®, 3 zoner med ablativ fraktioneret CO2-laser og 3 zoner uden forbehandling.
Efter udførelse af forbehandling blev MAL-creme påført på de 6 tildelte minizoner i 3 timers inkubation.
Hver tilstand blev testet med og uden okklusion.
De tre minizoner uden påført produkt blev brugt til at udføre biofysiske målinger.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Mand eller kvinde i ikke-fertil alder, som er mindst 18 år eller ældre ved screeningsbesøget.
- Forsøgspersonen har en hudfototype af I til III på Fitzpatricks skala (Fitzpatrick et al., 1993) ved screeningsbesøg.
- Forsøgspersonen skal have 9 minizoneområder på ryggen, som vil kunne modtage forbehandlinger i henhold til protokol. (kontrolleret ved screeningbesøg og tildelt ved baselinebesøg)
- Kvinde i ikke-fertil alder (postmenopausal [fravær af menstruationsblødning i 1 år før screeningsbesøg, uden anden medicinsk årsag], hysterektomi eller bilateral ooforektomi).
Ekskluderingskriterier:
- Person med porfyri,
- Person med tidligere hudkræft i anamnesen, eller aktuel klinisk diagnose af anden hudsygdom (herunder ikke-melanom hudkræft), eller tatoveringer eller cheloid- og hypertrofiske ar på testzonerne, som efter investigatorens mening kan interferere med fortolkning af de kliniske resultater,
- Enhver ukontrolleret eller alvorlig sygdom eller enhver medicinsk eller kirurgisk tilstand, der enten kan interferere med fortolkningen af de kliniske forsøgsresultater og/eller sætte forsøgspersonen i betydelig risiko (ifølge Investigators vurdering), hvis han/hun deltager i det kliniske forsøg .
- Kendte eller mistænkte allergier eller følsomheder over for komponenter i nogen af undersøgelseslægemidlerne (se produktetiketten).
- Forsøgspersonen har modtaget, anvendt eller taget nogle specifikke behandlinger inden for en specificeret tidsramme forud for baseline-besøget
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Mikronåle forbehandling og Metvixia
minizone med Microneedles forbehandling og Metvixia cremepåføring
|
Andre navne:
Andre navne:
|
|
Aktiv komparator: Mikronåle forbehandling og Metvixia under okklusion
minizone med Microneedles forbehandling og Metvixia cremepåføring med okklusion
|
Andre navne:
Andre navne:
|
|
Aktiv komparator: Laser forbehandling og Metvixia
minizone med laserforbehandling og Metvixia cremepåføring
|
Andre navne:
|
|
Aktiv komparator: Laserforbehandling og Metvixia under okklusion
minizone med Laser forbehandling og Metvixia cremepåføring med okklusion
|
Andre navne:
|
|
Aktiv komparator: Metvixia
minizone med Metvixia cremepåføring, uden forbehandling
|
Andre navne:
|
|
Aktiv komparator: Metvixia under okklusion
minizone med Metvixia creme påføring under okklusion, uden forbehandling
|
Andre navne:
|
|
Eksperimentel: Kun forbehandling af mikronåle
minizone kun med mikronåle forbehandling
|
Andre navne:
|
|
Eksperimentel: Kun laserforbehandling
minizone med kun laser forbehandling
|
|
|
Ingen indgriben: Normal hud
Normal hudkontrol mini-zone
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application)
Tidsramme: At T0 (before Metvixia® application )
|
Spectrofluorometer probe in contact with skin was used to measure surface, deeper skin fluorescence, using different photoactive Protoporphyrin IX (PpIX) excitation wavelengths.
Fluorescence measurements were used to estimate quantity of PpIX in skin, corresponding with degree of Metvixia® skin penetration.
Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes,1 hour(hr),2hr, 3hr after Metvixia® application (immediately after cream removal at 3hr time point).
Fluorescence data obtained using spectrofluorometer probe for two wavelengths that is, 405 nanometer(nm) measured fluorescence on skin surface, 632nm measured fluorescence in deep skin reported in this outcome measure.
Maximal value was used to characterize Peak Effect, time point of this value was used to characterize Time to Peak.
Negative values meant there was no longer fluorescence, it was corrected measurement derived from fluorescence.
|
At T0 (before Metvixia® application )
|
|
Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T30 (30 Minutes After Metvixia® Application)
Tidsramme: At T0+ 30 minutes (30 minutes after Metvixia® application)
|
A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths.
Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration.
Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point).
Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure.
The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak.
|
At T0+ 30 minutes (30 minutes after Metvixia® application)
|
|
Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 1 Hour (After Metvixia® Application)
Tidsramme: At 1 Hour (After Metvixia® Application)
|
A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths.
Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration.
Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point).
Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure.
The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak.
|
At 1 Hour (After Metvixia® Application)
|
|
Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 2 Hour (After Metvixia® Application)
Tidsramme: At T0+ 2 Hour (After Metvixia® Application)
|
A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths.
Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration.
Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point).
Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure.
The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak.
|
At T0+ 2 Hour (After Metvixia® Application)
|
|
Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 3 Hour (After Metvixia® Application)
Tidsramme: At 3 Hour (After Metvixia® Application)
|
A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths.
Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration.
Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point).
Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure.
The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak.
|
At 3 Hour (After Metvixia® Application)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Fluorescence Levels Measured by Mini-zone Photo Camera Device at Timepoint T0 (Before Metvixia® Application) and 3 Hours (After Metvixia® Application and Immediately After Cream Removal)
Tidsramme: At T0 (Before Metvixia® application) and 3 Hours (After Metvixia® Application and Immediately After Cream Removal)
|
A mini-zone camera device was used to measure skin surface fluorescence at a single excitation wavelength 405 nm before, and after Metvixia® application.
Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration.
This device uses the classical excitation wavelength: 405nm, was designed for Actinic Keratoses (AK) and had fluorescence references included.
Pictures were performed for each zone before pre-treatment and after cream removal at visit 2 (V2) for documentation of fluorescence.
|
At T0 (Before Metvixia® application) and 3 Hours (After Metvixia® Application and Immediately After Cream Removal)
|
|
Fluorescence Levels Measured by Trans-Epidermal Water Loss (TEWL) at Timepoint T0 (Before Metvixia® Application)
Tidsramme: At timepoint T0 (Before Metvixia® application)
|
TEWL evaluated the efficiency of the skin water barrier, which correlates with the degree of damage to the barrier function of the stratum corneum.
TEWL was assessed on the mini-zones that were not treated with Metvixia®.
It was measured in Grams of Water Per Square Meter Per Hour (g/m^2/hr).
|
At timepoint T0 (Before Metvixia® application)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2014
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
28. juli 2015
Først indsendt, der opfyldte QC-kriterier
28. juli 2015
Først opslået (Anslået)
29. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RD.03.SPR.40221E
- 2013-003371-35 (EudraCT nummer)
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