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A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients-protocol for a randomized controlled trial.

Publication ,  Journal Article
Eichner, B; Michaels, LAC; Branca, K; Ramsey, K; Mitchell, J; Morris, CD; Fagnan, LJ; Dolor, RJ; Elder, N; Hahn, DL; Nease, DE; Lapidus, J ...
Published in: Trials
March 4, 2020

BACKGROUND: Atopic dermatitis (AD) is a common, chronic skin disorder often beginning in infancy. Skin barrier dysfunction early in life serves as a central event in the pathogenesis of AD. In infants at high risk of developing AD, preventative application of lipid-rich emollients may reduce the risk of developing AD. This study aims to measure the effectiveness of this intervention in a population not selected for risk via a pragmatic, randomized, physician-blinded trial in the primary care setting. METHODS: Infant-parent dyads are recruited from a primary care practice participating through one of four practice-based research networks in Oregon, Colorado, Wisconsin, and North Carolina. Eligible dyads are randomized to the intervention (daily use of lipid-rich emollient) or the control (no emollient) group (n = 625 infants in each) and are followed for 24 months. The primary outcome is the cumulative incidence of physician-diagnosed AD and secondary outcomes include caregiver-reported measures of AD and development of other atopic diseases. Data collection occurs via chart review and surveys, with no study visits required. Data will be analyzed utilizing intention-to-treat principles. DISCUSSION: AD is a common skin condition in infants that affects quality of life and is associated with the development of other atopic diseases. If a safe intervention, such as application of lipid-rich emollients, in the general population effectively decreases AD prevalence, this could alter the guidance given by providers regarding routine skin care of infants. Because of the pragmatic design, we anticipate that this trial will yield generalizable results. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03409367. Registered on 11 February 2018.

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Published In

Trials

DOI

EISSN

1745-6215

Publication Date

March 4, 2020

Volume

21

Issue

1

Start / End Page

243

Location

England

Related Subject Headings

  • United States
  • Treatment Outcome
  • Surveys and Questionnaires
  • Skin Care
  • Quality of Life
  • Primary Prevention
  • Pragmatic Clinical Trials as Topic
  • Multicenter Studies as Topic
  • Infant
  • Incidence
 

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Eichner, B., Michaels, L. A. C., Branca, K., Ramsey, K., Mitchell, J., Morris, C. D., … Simpson, E. L. (2020). A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients-protocol for a randomized controlled trial. Trials, 21(1), 243. https://doi.org/10.1186/s13063-020-4150-5
Eichner, Brian, Le Ann C. Michaels, Kelsey Branca, Katrina Ramsey, Julie Mitchell, Cynthia D. Morris, Lyle J. Fagnan, et al. “A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients-protocol for a randomized controlled trial.Trials 21, no. 1 (March 4, 2020): 243. https://doi.org/10.1186/s13063-020-4150-5.
Eichner B, Michaels LAC, Branca K, Ramsey K, Mitchell J, Morris CD, Fagnan LJ, Dolor RJ, Elder N, Hahn DL, Nease DE, Lapidus J, Cibotti R, Block J, Simpson EL. A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients-protocol for a randomized controlled trial. Trials. 2020 Mar 4;21(1):243.
Journal cover image

Published In

Trials

DOI

EISSN

1745-6215

Publication Date

March 4, 2020

Volume

21

Issue

1

Start / End Page

243

Location

England

Related Subject Headings

  • United States
  • Treatment Outcome
  • Surveys and Questionnaires
  • Skin Care
  • Quality of Life
  • Primary Prevention
  • Pragmatic Clinical Trials as Topic
  • Multicenter Studies as Topic
  • Infant
  • Incidence