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The Effects of Emollient Therapy on the Skin Barrier (EES)

11. juli 2019 opdateret af: Eric Simpson, Oregon Health and Science University

The Effects of Emollient Therapy on the Skin Barrier Function

The goal of this study is to better understand what effect emollients (moisturizers) have on the skin in young children and adults.

Subjects will be recruited from PI and Sub-I clinics and Oregon Health & Science University (OHSU) research opportunities website.

  1. Adult and Adolescent Study:

    Moisturizer Intervention - There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Adults with a history of eczema will be asked to apply one of four possible moisturizers to one arm and nothing to the other arm for four weeks. The moisturizers, which will be assigned to the subjects, include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Vaseline 100% Petroleum Jelly. Subjects can use other skin treatments as needed for their skin condition, but may not treat the arms during the study. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2). The skin measurements that will be performed are:

    • Transepidermal loss (TEWL)- measures how much water is lost across the skin barrier
    • Skin Cohesion and TEWL - TEWL after 5, 10, 15, and 20 tape strips will measure skin barrier function after tape-stripping
    • Skin electrical capacitance - measures the moisture in the top layer of skin
    • Skin pH - measures the acidity of the skin
    • Stratum corneum cohesion assay - tape-stripping to measure the protein removed from the top layer of skin
    • Lipidomic analysis - measures the lipids, or oils, in the top layer of skin Control - There will be 1-2 visits for this group: a screening visit and baseline visit, which can be combined. Non-invasive tests of the skin will be taken and include the skin measurements that will be performed are the same as the Moisturizer Intervention group.

  2. Pediatric Study: There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Infants and toddlers between 3 months and 3 years of age without a history of skin barrier diseases will be assigned to a moisturizer, which include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Aveeno Skin Relief Moisture Repair Cream. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2).

    • TEWL- measures how much water is lost across the skin barrier
    • Skin electrical capacitance - measures the moisture in the top layer of skin
    • Skin pH - measures the acidity of the skin

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health & Science University Center for Health & Healing

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

3 måneder til 99 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

  1. Pediatric study

    • Inclusion Criteria

      • Enrollment in the BEEP emollient intervention study (IRB #6083)
      • Overall good health

    • Exclusion Criteria

      • Have a history of or are being evaluated for a skin barrier disease
      • Have an active skin infection
      • Are receiving phototherapy
      • Any immunodeficiency disorder or severe genetic skin disorder
      • Any other serious condition that would make the use of emollients inadvisable
      • Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention

  2. Adult Study

    • Inclusion Criteria

      • Have a history of atopic dermatitis
      • 12 years or older
      • 4 x 4 cm of non-lesional skin on both inner forearms
      • No other conditions that would make the use of the four emollients harmful to the subject, such as known allergy to an emollient or a component o the emollient

    • Exclusion Criteria

      • Use of topical steroids on the inner forearms or oral immunosuppressive medications for 4 weeks prior to participation in the study.
      • Receiving phototherapy or systemic immunosuppressive therapy three months prior to participation in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pediatric Moisturizer Intervention
Apply one of four moisturizers to one arm daily for four weeks.
Andet: Pediatric Moisturizer
Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
Andre navne:
  • Cetaphil Cream
  • Aveeno Eczema Therapy Moisturizing Cream
  • CeraVe Moisturizing Cream
  • Aveeno Skin Relief Moisture Repair Cream
Eksperimentel: Adult Moisturizer Intervention
Apply moisturizer to one arm once a day for four weeks.
Andet: Adult Moisturizer
Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
Andre navne:
  • Cetaphil Cream
  • Aveeno Eczema Therapy Moisturizing Cream
  • CeraVe Moisturizing Cream
  • Vaseline 100% Petroleum Jelly
Ingen indgriben: Adult Control
No intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with improved skin barrier function as a result of emollient use
Tidsramme: 3-4 weeks
Change in TEWL measurements of intervention arms compared to controls.
3-4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Oregon Health and Science University

Efterforskere

  • Ledende efterforsker: Eric Simpson, MD, MCR, Oregon Health & Science University, Department of Dermatology

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

1. januar 2011

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

8. februar 2011

Først indsendt, der opfyldte QC-kriterier

8. februar 2011

Først opslået (Skøn)

9. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Emollient Evaluation Study

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 .

Kliniske forsøg med Pediatric Moisturizer

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner