Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

433

Participants

Timeline

Start Date

November 21, 2022

Primary Completion Date

April 7, 2025

Study Completion Date

October 30, 2025

Conditions
Atopic Dermatitis
Interventions
BIOLOGICAL

Dupilumab

Adult dupilumab-naïve topical steroid non-responder (EASI \>7) participants beginning treatment with dupilumab will initially receive a loading dose of two 300 mg subcutaneous injections. The two injections will be administered at different sites in the abdomen, thighs, or upper arms. Pediatric dupilumab-naïve topical steroid non-responder participants beginning treatment with dupilumab will receive a loading dose, according to their weight. Dupilumab-naïve topical steroid non-responsive participants will continue use of dupilumab on a schedule determined by their age and weight until their penultimate scheduled visit (Day 140-196).

DRUG

Vanicream- Dupilumab-naïve

Dupilumab-naïve AD participants will apply Vanicream at least twice daily to the specified target skin area over two time periods during the study. First, they will apply starting at Day 0 through Day 7. They will resume application starting at their penultimate visit (Day 140-196) through the End of Study Assessment.

DRUG

Triamcinolone Acetonide

"On Day 7, all dupilumab-naïve AD participants will begin applying triamcinolone 0.1% ointment (provided by the study) twice daily to the specified target area. Additionally, dupilumab-naïve AD participants will apply triamcinolone 0.1% ointment twice daily to active lesions on non-sensitive, non-target skin.~Between Day 35 and Day 140, dupilumab-naïve AD topical steroid responsive (EASI ≤ 7) participants will apply triamcinolone 0.1% ointment (provided by the study) once or twice daily, per clinician discretion, to the specified target area. Additionally, participants will apply triamcinolone 0.1% ointment once or twice daily, per clinician discretion, to active lesions on non-sensitive skin body wide.~Between Day 35 and Day 140, dupilumab-naïve topical steroid non-responder (EASI \>7) participants may apply triamcinolone 0.1% ointment as needed to active lesions on non-sensitive, non-target skin."

DRUG

Hydrocortisone

"On Day 7, all dupilumab-naïve AD participants will apply hydrocortisone 2.5% ointment twice daily to active lesions on sensitive, non-target skin.~Between Day 35 and Day 140, dupilumab-naïve AD topical steroid responsive (EASI ≤ 7) participants will apply hydrocortisone 2.5% ointment once or twice daily, per clinician discretion, to active lesions on sensitive skin body wide.~Between Day 35 and Day 140, dupilumab-naïve topical steroid non-responder (EASI \>7) participants may apply hydrocortisone 2.5% ointment as needed to active lesions on sensitive, non-target skin."

DRUG

Vanicream- Active

Non-AD control participants will apply Vanicream at least twice daily to the specified target skin area over two time periods during the study. First, they will apply starting at Day 0 through Day 7. They will resume application starting at Day 140 through the End of Study Assessment Visit.

DRUG

Vanicream- Experienced Dupilumab

Long-term dupilumab participants will apply Vanicream at least twice daily to the specified target skin area over two time periods during the study. First, they will apply starting at Day 0 through Day 7. They will resume application starting at Day 140 through the End of Study Assessment Visit.

Trial Locations (10)

10029

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

14642

University of Rochester Medical Center: Department of Dermatology, Rochester

19104

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

27599

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

45229

Cincinnati Children's Hospital Medical Center: Asthma Center, Cincinnati

80206

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology, Denver

90027

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

92093

University of California, San Diego: Dermatology Clinical Trials Unit, La Jolla

97239

Oregon Health & Science University: Department of Dermatology, Portland

02215

Boston Children's Hospital: Department of Immunology, Boston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH