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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
ViraCor Laboratories |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01016106 |
Purpose
The investigators' primary objective is to identify common and rare mutations in the filaggrin gene in African American patients with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Atopic dermatitis, or eczema, is a common, chronic, relapsing and remitting problem in many children and affects 10-20% of the pediatric population. Itch is a predominant feature of this disease and is quite disruptive to daily activities of life. In addition to itch, it is characterized by markedly dry skin, small red bumps that may have fluid. Ichthyosis vulgaris is characterized by extremely dry, scaly skin with a fine white scale and increased amounts of lines noted on the palms. Filaggrin is a protein that is essential for the skin to function properly as a barrier and found to be mutated in some European patients with ichthyosis vulgaris and atopic dermatitis. This association has not been looked at in the African American population. Genomic DNA (gDNA) will be purified from buccal swabs using commercially available kits and analyzed.
| Condition | Intervention |
|---|---|
|
Atopic Dermatitis Ichthyosis Vulgaris |
Genetic: Buccal Swab |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Genetic Screening for Filaggrin Mutation in Atopic Dermatitis and Ichthyosis Vulgaris in the African American Population |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: AA pts AD and IV
African American patients with a diagnosis of atopic dermatitis and ichthyosis vulgaris
|
Genetic: Buccal Swab
During a single visit, a subject data collection form will be completed and DNA will be extracted from samples (buccal swabs) and then analyzed at IBT laboratories in Lenexa, Kansas.
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Active Comparator: AA patients (controls)
African American patients with no personal or family history of ichthyosis vulgaris or atopy
|
Genetic: Buccal Swab
During a single visit, a subject data collection form will be completed and DNA will be extracted from samples (buccal swabs) and then analyzed at IBT laboratories in Lenexa, Kansas.
|
Eligibility| Ages Eligible for Study: | 6 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| University of Chicago | |
| Chicago, Illinois, United States | |
| Principal Investigator: | Amy S Paller, MD | Northwestern University |
More Information
| Responsible Party: | Amy S. Paller, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01016106 History of Changes |
| Other Study ID Numbers: | CMH 2010-14049 |
| Study First Received: | November 17, 2009 |
| Last Updated: | June 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
eczema atopic dermatitis dry skin ichthyosis vulgaris |
|
Dermatitis Dermatitis, Atopic Ichthyosis Ichthyosis, Lamellar Ichthyosis Vulgaris Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Abnormalities Congenital Abnormalities Infant, Newborn, Diseases Keratosis Ichthyosiform Erythroderma, Congenital |