Seal, Stopping Eczema and Allergy Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 750
Summary
- Conditions
- Atopic Dermatitis
- Atopic Dermatitis (Eczema)
- Eczema
- Eczema, Infantile
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a randomized, controlled, parallel design trial designed for children (total n = 875) who are have already developed atopic dermatitis (AD or eczema) by 10 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).Masking: Double (Participant, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 10 years
- Gender
- Both males and females
Description
This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of the two proactive treatment arms versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 875 infants who have signs of dr...
This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of the two proactive treatment arms versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 875 infants who have signs of dry skin or atopic dermatitis between 0-10 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) or moisturizer 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).
Tracking Information
- NCT #
- NCT03742414
- Collaborators
- King's College London
- National Jewish Health
- National Institute of Allergy and Infectious Diseases (NIAID)
- University of Chicago
- Benaroya Research Institute
- Investigators
- Principal Investigator: Kari Nadeau, MD PhD Stanford University
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