- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01291940
The Effects of Emollient Therapy on the Skin Barrier (EES)
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.
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.
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University Center for Health & Healing
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Pediatric Moisturizer Intervention
Apply one of four moisturizers to one arm daily for four weeks.
|
Apply moisturizer for four weeks daily to only one arm.
Do not apply moisturizer to the other arm.
Andre navn:
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Eksperimentell: Adult Moisturizer Intervention
Apply moisturizer to one arm once a day for four weeks.
|
Apply moisturizer for four weeks daily to only one arm.
Do not apply moisturizer to the other arm.
Andre navn:
|
Ingen inngripen: Adult Control
No intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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3-4 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Eric Simpson, MD, MCR, Oregon Health & Science University, Department of Dermatology
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Emollient Evaluation Study
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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