Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema, Eczema, Infantile
Conditions
Keywords
Dermatitis, Dry skin, Food allergy, Moisturizer
Brief summary
This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Detailed description
This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of a proactive treatment arm versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 398 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Interventions
OTHERStandard of Care
Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares.
COMBINATION_PRODUCTTri-lipid skin barrier cream (Epiceram)
The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
COMBINATION_PRODUCTFluticasone propionate Cream 0.05%
Proactive use of fluticasone proprionate cream for inflammation of the skin, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Sponsors
Kari Nadeau, MD, PhD
National Jewish Health
University of Chicago
Children's Hospital Medical Center, Cincinnati
Harvard School of Public Health (HSPH)
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
King's College London
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a randomized, controlled, parallel design trial designed for children (total n = 398) who have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) or moisturizer and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 12 Weeks
Healthy volunteers
No
Inclusion criteria
1. Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age. 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. In good general health as evidenced by medical history 4. No known adverse reaction to any of the study medications, their components or excipients
Exclusion criteria
1. Infants \<3kg body weight 2. Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency) 3. Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism 4. Parents or guardians unwilling to sign consent 5. Current participant or participation since birth in any interventional study 6. Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU) 7. A course of antibiotics in infant within 7 days of enrollment 8. Any known food allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of foods each participant is sensitized to | 2 years | Sensitization is defined as food-specific IgE \> 0.1 kU/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of foods each participant is sensitized to | 24 months of age | Sensitization is defined as food-specific skin prick test (SPT) ≥ 1 mm |
| Presence, duration, and severity of dry skin and/or AD by clinical assessment | Baseline, 12, and 24 months of age and as necessary | Patient-oriented SCORAD (PO-SCORAD) application used |
| The per-subject cumulative number of proven Food Allergy | 2 years | Double-blind placebo-controlled oral food challenges used |
Countries
United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORKari Nadeau, MD, PhD
Harvard
Outcome results
None listed