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NCT06464133 Clinical Trial

Investigation of Filaggrin Gene Mutations Among Latinx Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
Investigation of Filaggrin Gene Mutations Among Latinx Patients With Atopic Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06464133
Other study ID # 853590
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 15, 2024
Est. completion date December 31, 2027

Study information
Verified date June 2024
Source University of Pennsylvania
Contact Jennifer Mason, MPH
Phone 215-662-7546
Email jennifer.mason1@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study, Investigation of Filaggrin Gene Mutations among Latinx patients with Atopic Dermatitis, will examine the association between pathogenic FLG LOF variants and AD in a new population of Latinx patients for which clinical and disease characteristics will be well-described.

Description:

Filaggrin deficiency is considered a major target for therapy in Atopic Dermatitis (AD).43 The current status quo with regards to FLG LOF mutations as the strongest known genetic risk factor in AD stems from incomplete data as the majority of studies that have previously examined this association have been carried out in only a limited group of populations (i.e., European ancestry).30 Such partial data impedes our full understanding of genetic risk in AD and consequently has implications for disease prognosis and management. The proposed research represents an attempt to examine long-held paradigms in AD as they relate to genetic risk factors and disease. The development of an independent cohort of Latinx subjects with physician-confirmed diagnosis of AD that is also well phenotyped and grouped by ancestry, while also capturing measures of disease severity, will provide the opportunity to examine a population that has been largely absent from prior studies and further advance our understanding of the pathogenomic role FLG LOF variants in AD.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Established diagnosis of AD based on physician report of at least one-year duration - Self-identification as Latino/Latinx or Hispanic Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Outcome
Type Measure Description Time frame Safety issue
Other To examine the association between loss of function (LOF) Filaggrin (FLG) mutations and disease onset and severity among Latinx patients with atopic dermatitis (AD). 2 year data/sample collection period - cross-sectional cohort study of patients with a diagnosis of atopic dermatitis
Primary To identify and describe Filaggrin (FLG) loss of function (LOF) variants in the GAD-L cohort using a high-throughput PCR approach that incorporates Fluidigm microfluidics technology and next-generation sequencing (NGS) to sequence the entire FLG gene. 2 year data/sample collection period - cross-sectional cohort study of patients with a diagnosis of atopic dermatitis
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