NCT01782703|Active Not Recruiting
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Sponsor study identifier
observational
505
1 country
4
Study Start
January 2013
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder of children, affecting 10-20% of children and 1-2% of adults. This skin disorder can be associated with unbearable itchiness and an increased susceptibility to skin infections. The cause of AD is currently poorly understood; therefore, there are no targeted treatment options at present. There have been recent studies in adults with AD that explain the cause and give us new routes to investigate treatment options, however no major studies in this arena have been done in children. We hope to evaluate the skin and blood biomarkers that are found in pediatric AD and compare them to adult AD. Hypothesis: The immune system worsens the skin barrier issues that are common in atopic dermatitis. We believe there are similar immune and skin abnormalities in adult versus pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic dermatitis can serve as surrogates for skin immune activation and will correlate with disease severity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Actual (reported)January 31, 2013
Actual (reported)February 4, 2013
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Cellular infiltrates
We will examine skin and blood samples for various immune cells known to be involved in atopic dermatitis.
One year
Gene expression
We will examine skin and blood samples for various genes known to contribute to atopic dermatitis by analyzing RNA and cytokines.
One Year
Correlation of biomarkers to quality of life
One year
Development of a panel of non-invasive biomarkers from tape strip samples
Two years
Healthy subjects with no history of atopy (atopic dermatitis, asthma, or allergic rhinitis) from 0 months to 17 years of age that are age and sex matched to our atopic dermatitis subjects.
Children with atopic dermatitis from 0 months to 17 years of age.
Healthy subjects from 0 months to 17 years of age with history of asthma, food allergies, or allergic rhinitis, but no atopic dermatitis or with positive family history of atopy
Subjects will be recruited at Ann and Robert H. Lurie Children's Hospital Dermatology outpatient clinics. * 200 children with mild to severe AD, 100 aged-matched and sex-matched healthy (no evidence of atopy) controls, 100 aged-matched and sex-matched controls with an atopic condition (allergic rhinitis or asthma) but no history of atopic dermatitis * AD subjects between the ages of 0 months to 4 years of age will be asked to give buccal (cheek) swabs * 70 children with mild to severe atopic dermatitis, and 70 age- and sex-matched (but not site-matched) healthy controls (no evidence of atopy), will be enrolled to obtain skin biopsies. * 30 children with atopic dermatitis and 30 age/sex matched non-atopic controls for imaging evaluation. * Transepidermal water loss values will obtained in 300 healthy controls. * Cord blood will be collected from 30 healthy subjects at the time of delivery.
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
Northbrook Lurie Children's Outpatient Clinic
Northbrook, Illinois, 60062, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10065, United States
Bieber T. Atopic dermatitis. Ann Dermatol. 2010 May;22(2):125-37. doi: 10.5021/ad.2010.22.2.125. Epub 2010 May 17.
Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part II: immune cell subsets and therapeutic concepts. J Allergy Clin Immunol. 2011 Jun;127(6):1420-32. doi: 10.1016/j.jaci.2011.01.054. Epub 2011 Mar 21.
Guttman-Yassky E, Nograles KE, Krueger JG. Contrasting pathogenesis of atopic dermatitis and psoriasis--part I: clinical and pathologic concepts. J Allergy Clin Immunol. 2011 May;127(5):1110-8. doi: 10.1016/j.jaci.2011.01.053. Epub 2011 Mar 8.
We have retained whole blood and tissue samples (skin and cheek swabs)
Amy Paller, MD
Northwestern University
Emma Guttman, MD
Icahn School of Medicine at Mount Sinai
505 participants (actual enrollment reported by the registry).
First Submitted
January 31, 2013
First Posted
February 4, 2013
Study Start
January 2013
Actual (reported)The Effects of Emollient Therapy on the Skin Barrier
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Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 27, 2026
Record last verified: 2026-04
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