NCT06464133

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

May 10, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

January 23, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

May 10, 2024

Last Update Submit

April 23, 2026

Conditions

Atopic DermatitisEczema

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (1)

  • To examine the correlation 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who self-identify as Latino/Latinx or Hispanic ethnicity and who have an established diagnosis of AD based on physician report of at least one-year duration will be considered eligible for this study.

You may qualify if:

  • Established diagnosis of AD based on physician report of at least one-year duration
  • Self-identification as Latino/Latinx or Hispanic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Pennsylvania

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2024

First Posted

June 18, 2024

Study Start

January 23, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)