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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University Center for Health & Healing
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Pediatric Moisturizer Intervention
Apply one of four moisturizers to one arm daily for four weeks.
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Apply moisturizer for four weeks daily to only one arm.
Do not apply moisturizer to the other arm.
Outros nomes:
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Experimental: Adult Moisturizer Intervention
Apply moisturizer to one arm once a day for four weeks.
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Apply moisturizer for four weeks daily to only one arm.
Do not apply moisturizer to the other arm.
Outros nomes:
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Sem intervenção: Adult Control
No intervention.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants with improved skin barrier function as a result of emollient use
Prazo: 3-4 weeks
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Change in TEWL measurements of intervention arms compared to controls.
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3-4 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric Simpson, MD, MCR, Oregon Health & Science University, Department of Dermatology
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Emollient Evaluation Study
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