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A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE)

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ClinicalTrials.gov Identifier: NCT03409367
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborators:
University of Wisconsin, Madison
University of Colorado, Denver
Duke University
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University

Brief Summary:

Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.

Our central hypothesis is that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Atopic Disorders Eczema Atopic Eczema Other: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream Not Applicable

Detailed Description:

AD affects over 9 million children in the U.S. and ranks first among all skin conditions in global disability burden. AD often heralds the development of several comorbidities including asthma, food allergy, skin infections and neurodevelopmental disorders. Because of the significant socioeconomic impact of atopic dermatitis and its effect on the quality of life of children and families, there have been decades of research focused on prevention with limited success. Recent advances in cutaneous biology identify epidermal defects and skin barrier dysfunction to be the key initiators of atopic dermatitis and possibly allergic sensitization. Our central hypothesis is that emollient therapy from birth can prevent the development of AD. The findings of this trial will support the development of evidence-based skin care clinical guidelines for infants that currently do not exist. Recently, our international multi-centered clinical trial found enhancing early skin barrier function with daily emollient use from birth significantly reduces the risk of AD development in high-risk populations by 50%. With CASCADE, we extend this work into the community setting and into newborns unselected for risk, so results will be immediately applicable to the population at large and will establish a new standard of care for all newborns.

The specific aims are as follows:

  1. Perform a community-based pragmatic randomized controlled trial investigating whether daily full-body emollient application starting in the first 2 months of life prevents atopic dermatitis in a real-world setting. The population for this trial consists of newborns between 0-2monthsof age, not selected for risk. Recruitment of families will occur during the course of routine care within primary care offices that are members of practice-based research networks(PBRNs).The intervention includes general skin care recommendations plus full-body daily lipid-rich emollient use. The control population will receive general skin care advice only and refrain from daily emollient use. The primary outcome will be the cumulative incidence of atopic dermatitis at age 24 months as determined by blinded clinicians trained in the diagnosis of AD. Key secondary clinical outcomes include time to disease onset and incidence of self-reported food allergy and wheeze using parental questionnaires.
  2. As an exploratory aim, determine whether a family history of allergic disease and key early life exposures such as pet ownership modify the preventive effect of emollient therapy on atopic dermatitis. While the primary objective of this clinical trial is to determine the effectiveness of an emollient intervention in a real-world setting, data will be gathered on allergy history in the family and pet ownership-variables that may modify the effect of emollient therapy. Future implementation studies may target subpopulations found most likely to benefit from emollient intervention.

Twenty-five primary care clinics that participate in PBRNs from Oregon, Colorado, Wisconsin and North Carolina are the setting for the study protocol. The expected results from this project would represent a major public health breakthrough with the potential for reducing the atopic disease burden on a global scale.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pragmatic, multi-site, randomized community-based trial in which dyads of a parent or legal guardian ("parent") and an infant age 0 to 2 months are enrolled. Participating dyads are randomly assigned to receive lipid-rich emollient with web-based instructions for daily use to infants plus routine skin care instructions (every day moisturizer group) or routine skin care instructions alone (natural skin group). Both groups will receive e-mail and text message reminders to follow protocol instructions based on their group allocation until the infant reaches 24 months old.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Due to the nature of the intervention, it is not possible blind dyads to the intervention. Administering a placebo emollient is impossible as there are no active ingredients in the emollient and using an emollient that has no barrier improvement properties may irritate the skin. The clinician completing the final assessment will be a blinded assessor.

Clinic staff will not be informed of participant enrollment or study arm. Parents will be instructed not to disclose their treatment group to clinic staff. Clinicians and clinic staff will direct participants to follow skin care recommendations as described by the study materials.

Blinded researchers will be responsible for health record review to collect the primary outcome. At completion of health record review, researchers will complete a form measuring whether the assessor became unblinded while reviewing the record.

Primary Purpose: Prevention
Official Title: A Community-based Assessment of Skin Care, Allergies, and Eczema
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Eczema

Arm Intervention/treatment
Experimental: Daily Emollient
Parents assigned to the intervention arm will receive a lipid-rich emollient and educational materials promoting once daily full-body emollient use until their infant is 24 months old. Parents will select one of five emollients to be mailed to the dyad's home at enrollment and approximately every six months for the duration of the study. These emollients include (1) CeraVe Healing Ointment, (2) Vaseline, (3) Cetaphil cream, (4) CeraVe cream, and (5) Vanicream.
Other: Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream
Lipid-rich emollient serving as skin barrier

No Intervention: Natural Skin
Parents assigned to the control arm will receive educational materials promoting general infant skin care guidelines only and will be asked to refrain from emollient use unless dry skin develops (current standard of care guidelines).



Primary Outcome Measures :
  1. Cumulative incidence of AD [ Time Frame: 24 months ]
    The cumulative incidence of AD at 24 months of age as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record.


Secondary Outcome Measures :
  1. Parental report [ Time Frame: 3, 6, 9, 12, 15, 18 and 24 months ]
    Parental report of provider-diagnosed AD

  2. Children's Eczema Questionnaire [ Time Frame: 12 and 24 months ]
    AD as diagnosed by the Children's Eczema Questionnaire (CEQ)

  3. Sleep loss [ Time Frame: 12 and 24 months ]
    Parental report of sleep loss of the infant reported as average number of days per week (1 week recall) of disrupted sleep in their infant

  4. Prescription topical skin medication [ Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months ]
    Any prescription topical medication use or over-the-counter hydrocortisone usage recorded by parent or recorded from records review

  5. Asthma risk [ Time Frame: 12 and 24 months ]
    Asthma risk using a modification of the Asthma Predictive Index

  6. Food allergy symptoms [ Time Frame: 12 and 24 months ]
    Parental report of immediate food allergy symptoms

  7. Food allergy clinician diagnosed [ Time Frame: 12 and 24 months ]
    Parental report of a provider diagnosis of food allergy that was confirmed by prick testing or IgE blood test

  8. Global Health Status [ Time Frame: 12 and 24 months ]
    Global Health Status using one question from the PROMIS Pediatric Global Health (PGH-7) instrument

  9. Atopic dermatitis severity 1 [ Time Frame: 12 and 24 months ]
    In infants who develop AD: (1)Time to onset of AD as measured by parental report of eczema age of onset

  10. Atopic dermatitis severity 2 [ Time Frame: 12 and 24 months ]
    In infants who develop AD: (2) Time to onset of AD as measured by provider-recorded date of first diagnosis retrieved from record review of health record

  11. Atopic dermatitis severity 3 [ Time Frame: 12 and 24 months ]
    In infants who develop AD: (3) AD symptom severity as reported by the patient-oriented eczema measure (POEM) instrument

  12. Atopic dermatitis severity 4 [ Time Frame: 12 and 24 months ]
    In infants who develop AD: (4) Parent-reported global severity of eczema assessment

  13. Atopic dermatitis severity 5 [ Time Frame: 12 and 24 months ]
    In infants who develop AD: (5) Infant Dermatology Quality of Life Instrument (IDQOL)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parent can provide electronic signed and dated informed consent form.
  • Parent is willing and able to comply with all study procedures for the duration of the study.
  • Parent is a primary caretaker of an infant 0 to 2 months of age.
  • Parent is 18 years of age or older at time of consent.
  • Parent can speak, read, and write in English or Spanish.
  • Parent has a valid e-mail address and reliable access to the internet.
  • Infant is a patient of a participating Meta-LARC clinic site at the time of consent.

Exclusion Criteria:

  • Infant was born at less than 25 weeks gestational age.
  • Infant has established eczema as diagnosed by the primary healthcare provider at clinic site of enrollment per parent report.
  • Infant has known adverse reaction to petrolatum-based emollients.
  • Infant has an immunodeficiency genetic syndrome such as Wiskott-Aldrich Syndrome or Severe Combined Immunodeficiency Syndrome.
  • Infant has extremely low birth weight (less than 1000g or 2.2 lbs at birth).
  • Infant has a sibling enrolled in the study.
  • Parent is unwilling or unable to comply with study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409367


Contacts
Contact: LeAnn Michaels 503-494-1583 michaell@ohsu.edu
Contact: Clara Stemwedel stemwedc@ohsu.edu

Locations
United States, Colorado
University of Colorado-Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Cat Halliwell, MPH         
Contact: Mary Fisher, MPH         
Sub-Investigator: Donald Nease, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: LeAnn C Michaels    503-494-1583    michaell@ohsu.edu   
Sub-Investigator: Lyle Fagnan, MD         
Sponsors and Collaborators
Oregon Health and Science University
University of Wisconsin, Madison
University of Colorado, Denver
Duke University
Investigators
Principal Investigator: Eric Simpson, MD Oregon Health and Science University

Responsible Party: Eric Simpson, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03409367     History of Changes
Other Study ID Numbers: 1 U01 AR071057-01A1
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing will be according to the NIAMS guidelines
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Supporting information will be shared per NIAMS guidelines

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eric Simpson, Oregon Health and Science University:
Prevention
Emollient
Pragmatic clinical trial

Additional relevant MeSH terms:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Petrolatum
Dermatologic Agents