Clinical trial NCT03742414: Seal, Stopping Eczema and Allergy Study
Official title: SEAL (Stopping Eczema and ALlergy) Study: Prevent the Allergic March by Enhancing the Skin Barrier
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Eczema, Infantile
Eczema
Atopic Dermatitis Eczema
Atopic Dermatitis
Keywords: Dermatitis
Dry skin
Food allergy
Moisturizer
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Jewish Health
name: University of Chicago
name: Children's Hospital Medical Center, Cincinnati
name: Harvard School of Public Health (HSPH)
name: Stanford University
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: King's College London
name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2018-11-15
Enrollment: 312
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled, parallel design trial designed for children (total n = 312) 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).
Primary purpose: PREVENTION

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 312 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).

Eligibility criteria: 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

Primary outcomes:
measure: number of foods each participant is sensitized to
timeFrame: 2 years
Secondary outcomes:
measure: The per-subject cumulative number of proven Food Allergy
timeFrame: 2 years
measure: Number of foods each participant is sensitized to
timeFrame: 24 months of age
measure: Number of foods each participant is sensitized to
timeFrame: 24 months of age
measure: Presence, duration, and severity of dry skin and/or AD by clinical assessment
timeFrame: Baseline, 12, and 24 months of age and as necessary
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Sean N. Parker Center for Allergy & Asthma Research at Stanford University
state: California
city: Denver
country: United States
facility: Division of Pediatric Allergy and Clinical Immunology, National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: London
country: United Kingdom
facility: • King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK
Study officials:
affiliation: Harvard
name: Kari Nadeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: