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Natreon Healthy Skin Study - PrimaVie Supplement

1. juni 2026 opdateret af: Gayle Gordillo, Ohio State University

Evnen af ​​et oralt tilskud til at forbedre hudens mikroperfusion, hydrering, elasticitet og barrierefunktion

Denne undersøgelse vil demonstrere evnen af ​​det orale supplement, PrimaVie®, til at forbedre hudens mikroperfusion, hydrering, elasticitet og barrierefunktion. 45 kvinder vil blive indskrevet i 1 af 3 arme, hvor de vil modtage enten 125 mg PrimaVie, 250 mg PrimaVie eller placebo (kontrol) til at tage to gange dagligt i 14 uger.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Forsøgspersoner vil blive vurderet ud fra den type Fitzpatrick-hudtype de har, vil blive returneret for i alt 6 studiebesøg over 14 uger, hvor følgende forskningsaktiviteter vil finde sted i løbet af studiet: medicinsk/diætanamnese, medicin vil registreres, vil tillægsrandomisering baseret på en af ​​de tre arme finde sted ved studiebesøg 1, og distribution af undersøgelsesproduktet vil ske ved alle studiebesøg, supplerende tolerabilitetsvurdering, vurdering af investigator og forsøgspersons udseende, fotografering af ansigtet (venstre, højre og front) vil blive taget, ikke-invasive vurderinger, herunder transepidermalt vandtab, hydrering, elasticitet, laserpletter perfusion, en hudbiopsi af venstre indre overarm (kun ved studiebesøg 2 og 6), gennemgang af bivirkninger og supplement optælling/compliance gennemgang.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
45

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Davis Heart and Lung Research Institute
      • Columbus, Ohio, Forenede Stater, 43221
        • Martha Morehouse Medical Plaza 2050 Kenny Road
      • Columbus, Ohio, Forenede Stater, 43205
        • OSU Hospital East

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

30 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Forsøgspersoner, der er villige til at afbryde ethvert kost- eller kosttilskud, bortset fra et generelt multivitamin, begyndende to uger før påbegyndelse af undersøgelsen og også under undersøgelsen.
  • Forsøgspersonerne skal være villige til at opretholde deres nuværende kost uden større ændringer gennem hele undersøgelsen.
  • Forsøgspersonerne skal være villige til at tage kosttilskud som krævet af undersøgelsesprotokollen to gange dagligt.
  • Kvindelige forsøgspersoner skal være mellem 30 og 65 år
  • Forsøgspersoner skal give skriftligt informeret samtykke og er villige til at overholde alle undersøgelsesprocedurer.

Ekskluderingskriterier:

  • Enhver dermatologisk lidelse, der kan forstyrre den nøjagtige evaluering af forsøgspersonens hud.
  • Forsøgspersoner, der er gravide, ammer eller planlægger en graviditet.
  • Klinisk signifikante ustabile medicinske lidelser.
  • Anamnese med diabetes, hjerte- eller nyresygdom
  • Historie om en psykisk sygdom eller tilstand, der ville forstyrre deres evne til at forstå og følge undersøgelsens krav.
  • Enhver hudsygdom i det område af overarmen, hvor biopsierne vil blive taget.

  • Tager i øjeblikket følgende medicin:

    • Steroider
    • Beta-blokkere
    • Immunsuppressiva
    • Hydochlorthiazid,
    • Statiner
    • Aspirin
    • ACE-hæmmere
    • Muskelafslappende midler
    • Stimulerende midler
  • Fanger
  • Hanner

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: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Aktiv komparator: Arm 1
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
Kosttilskud: PrimaVie urtetilskud 125
125 mg for at tage BID i 14 uger i arm 1
Andre navne:
  • PrimaVie
Aktiv komparator: Arm 2
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
Kosttilskud: PrimaVie urtetilskud 250
250 mg for at tage BID i 14 uger i arm 2
Andre navne:
  • PrimaVie
Placebo komparator: Arm 3
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
Medicin: Placebo
Placebo-tilskud til at tage BID i 14 uger i arm 3
Andre navne:
  • kontroltillæg

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Tidsramme: 14 weeks after oral supplementation
To see the improvement in noninvasive skin assessment of objective measurements such as skin microperfusion (laser speckle contrast imaging) (scale Pu). An increase in PU means improved perfusion of the skin.
14 weeks after oral supplementation
Improvement in Non-invasive Skin Assessment of Hydration
Tidsramme: 14 weeks after oral supplementation
To see the improvement in noninvasive skin assessment of objective measurements such as skin hydration using the DermaLab Combo Series (unit of micro-Siemens uS), which are arbitrary. An increase in uS means improved skin hydration and improved skin barrier function.
14 weeks after oral supplementation
Improvement in Non-invasive Skin Assessment of Elasticity
Tidsramme: 14 weeks after oral supplementation
To see the improvement in noninvasive skin assessment of objective measurements such as skin elasticity using the DermaLab Combo Series (mega Pascal mPa). An increase in mPA means worsening of skin elasticity.
14 weeks after oral supplementation
Improvement in Non-invasive Skin Assessment of Barrier Function
Tidsramme: 14 weeks after oral supplementation
To see the improvement in noninvasive skin assessment of objective measurements such as barrier function using Trans-Epidermal Water Loss (TEWL) using the DermaLab Combo Series (g/m2/h). An increase in these units indicates a worsening of TEWL, and reduction of the barrier function of the skin.
14 weeks after oral supplementation

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Genchip analyse
Tidsramme: 14 uger
identificere op- eller nedreguleringen af ​​vigtige ungdommelige hudmarkører (genekspression) produceret af tilskuddet over placebo som identificeret ved genchipanalyse efter 14 ugers oral tilskud.
14 uger

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80 AU.

The gene of interest examined here is ITGA5 - Integrin Subunit Alpha 5. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of the ITGA5 are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis: JAM3 - Junctional Adhesion Molecule 3
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80 AU.

The gene of interest examined here is JAM3- Junctional Adhesion Molecule 3. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of the JAM3 are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - LGALS1 - Galectin 1
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is LGALS1 - Galectin 1. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of LGALS1- Galectin 1 are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - LOX- Lysyl Oxidase
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is LOX- Lysyl Oxidase. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of LOX- Lysyl Oxidase are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - MMP2 - Matrix Metallopeptidase 2
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is MMP2- Matrix Metallopeptidase 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of MMP2- Matrix Metallopeptidase 2 are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - PDGFRB - Platelet-Derived Growth Factor Receptor Beta
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is PDGFRB- Platelet-Derived Growth Factor Receptor Beta. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of PDGFRB- Platelet-Derived Growth Factor Receptor Beta may be associated with better blood flow in tissue.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - PRKG1 - Protein Kinase, cGMP-Dependent, Type I
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is PRKG1- Protein Kinase, cGMP-Dependent, Type I. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of PRKG1- Protein Kinase, cGMP-Dependent, Type I may be associated with better blood flow in tissue.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - SERPINE1 - Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1)
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is SERPINE1- Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1). Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of SERPINE1- Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1) may be associated with better blood flow in tissue.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - SPARC - Secreted Protein Acidic and Cysteine Rich
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is SPARC- Secreted Protein Acidic and Cysteine Rich. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of SPARC- Secreted Protein Acidic and Cysteine Rich may be associated with better blood flow in tissue.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - THBS2 - Thrombospondin 2
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is THBS2- Thrombospondin 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of THBS2- Thrombospondin 2 are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - TIMP1 - Tissue Inhibitor of Metalloproteinases 1
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is TIMP1 - Tissue Inhibitor of Metalloproteinases 1. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TIMP1 - Tissue Inhibitor of Metalloproteinases 1 are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - TIMP2 - Tissue Inhibitor of Metalloproteinases 2
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is TIMP2 - Tissue Inhibitor of Metalloproteinases 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TIMP2 - Tissue Inhibitor of Metalloproteinases 2 are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - TNN - Tenascin N
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator).

The gene of interest examined here is TNN- Tenascin N. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TNN- Tenascin N are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - RECK - Reversion-Inducing Cysteine-Rich Protein With Kazal Motifs
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator).

The gene of interest examined here is RECK - Reversion-Inducing Cysteine-Rich Protein with Kazal Motifs. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of RECK - Reversion-Inducing Cysteine-Rich Protein with Kazal Motifsare predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - COL1A1 - Collagen Type I Alpha 1 Chain
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is COL1A1 - Collagen Type I Alpha 1 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL1A1 - Collagen Type I Alpha 1 Chain are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - COL5A2 - Collagen Type V Alpha 2 Chain
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is COL5A2 - Collagen Type V Alpha 2 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL5A2 - Collagen Type V Alpha 2 Chain are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks
Gene Chip Analysis - COL14A1 - Collagen Type XIV Alpha 1 Chain
Tidsramme: 14 weeks

We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU.

The gene of interest examined here is COL14A1 - Collagen Type XIV Alpha 1 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL14A1 - Collagen Type XIV Alpha 1 Chain are predicted to be associated with improved outcomes related to extracellular matrix production.

For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate.
14 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Ohio State University

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Natreon, Inc.

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Gayle M Gordillo, M.D., Indiana University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
20. februar 2016

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. december 2018

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
20. december 2019

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
21. marts 2016

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
3. maj 2016

Først opslået (Anslået)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
4. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
1. juni 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • DCS-71-14

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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