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Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis | Clinical Trials | Clareo Health

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Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis (ADRN-12)

NCT05436535•National Institute of Allergy and Infectious Diseases (NIAID)

Summary

This is a multi-center, longitudinal study which will characterize the gene expression profiles and transcriptomic endotypes that underlie mild and moderate-severe Atopic dermatitis (AD) and will determine changes in these expression patterns and endotypes in response to standard-of-care treatment. Participants will complete up to ten scheduled study visits with assessment of topical steroid response and dupilumab response (if uncontrolled with topical steroids). Skin samples will be collected at all study visits to determine the gene expression profiles and transcriptomic endotypes that underlie mild vs. moderate-severe AD disease. The investigators will also evaluate the lipidomic, metabolomic, proteomic, and microbiome profiles of AD skin endotypes associated with mild and moderate-severe AD disease. Non-AD participants will serve as a control population. The primary objective of this study is to determine if the type 2-high non-lesional skin (skin tape) endotype is associated with current mild versus moderate-severe AD disease.

Eligibility

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•All Participants:
•1. Participant and/or parent guardian must be able to understand and provide informed consent and assent (if applicable)
•2. Male or female, 6 years of age or older inclusive at the Screening Visit
•3. Participants must agree to apply a stable dose of a study provided topical moisturizer (Vanicream (TM)) at least twice daily between the Baseline Assessment and Day 7 Visits to a specified skin target area
•4. Individuals with asthma must adhere to asthma controller medication(s) for the duration of the study
•5. Individuals who can become pregnant, as defined in the study manual of procedures, must have a negative pregnancy test at the Baseline Assessment and Day 7 Visits if they do not self-report as pregnant.
•6. Individuals who can become pregnant, as defined in the study manual of procedures, must meet either of the following criteria prior to Baseline Assessment:
•1. Willing to remain abstinent from intercourse that may result in pregnancy.
•2. Willing to use Food and Drug Administration (FDA) approved methods of contraception for the duration of the study
•7. Participant and/or parent guardian must be able to understand and complete study-related questionnaires.
+10 more criteria

Exclusion Criteria

•1. Inability or unwillingness of a participant or parent guardian to comply with study protocol
•2. Have a genetic relative (e.g., parent, sibling, grandchild, half-sibling) or household member (e.g., spouse) already enrolled in the study
•3. Weight less than 15 kg
•4. Known systemic hypersensitivity to any of the excipients of the study treatments (Vanicream (TM), hydrocortisone, triamcinolone, or dupilumab)
•5. Have any skin disease other than Atopic dermatitis (AD) that might compromise the stratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous T cell lymphoma \[also called Mycosis Fungoides or Sezary syndrome\], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease)
•6. Known or suspected immunosuppression, including history of invasive opportunistic infections (e.g. tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution, or otherwise recurrent immune-compromised status, as judged by investigator
•7. Known history of human immunodeficiency virus (HIV) infection
•8. Ocular disorder that in the opinion of the investigator could adversely affect the individual's risk for study participation. Examples include, but are not limited to, individuals with a history of or active case of herpes keratitis; Sjogren's Syndrome, Keratoconjunctivitis Sicca, or Dry Eye Syndrome that require daily use of supplemental lubrication; or individuals with ocular conditions that require the regular use of ocular corticosteroids or cyclosporine
•9. Parasitic infection, except for vaginal trichomoniasis, within 12 months of the Screening Visit, or high risk for contracting parasitic infections (e.g. living in or traveling to endemic areas)
•10. History of malignancy within 5 years before the Screening Visit (completely treated in situ carcinoma of the cervix, and completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin or melanoma in situ are not exclusionary)
+29 more criteria

Locations (10)

University of California, San Diego: Dermatology Clinical Trials Unit

La Jolla, California, United States

Children's Hospital Los Angeles: Division of Clinical Immunology & Allergy

Los Angeles, California, United States

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Denver, Colorado, United States

Boston Children's Hospital: Department of Immunology

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

New York, New York, United States

University of Rochester Medical Center: Department of Dermatology

Rochester, New York, United States

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, United States

Oregon Health & Science University: Department of Dermatology

Portland, Oregon, United States

University of Pennsylvania, Perelman Center for Advanced Medicine: Department of Dermatology

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

November 21, 2022

Primary Completion Date

April 7, 2025

Completion Date

October 24, 2025

Last Updated

February 19, 2026

Enrollment

433

ACTUAL participants

Conditions

Atopic Dermatitis

Interventions

Dupilumab

BIOLOGICAL

Vanicream- Dupilumab-naïve

DRUG

Triamcinolone Acetonide

DRUG

Hydrocortisone

DRUG

Vanicream- Active

DRUG

Vanicream- Experienced Dupilumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

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