Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

Last updated: May 12, 2025
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Status: Active - Not Recruiting

Phase

4

Condition

Dermatitis, Atopic

Skin Infections/disorders

Eczema (Atopic Dermatitis)

Treatment

Dupilumab

Vanicream- Dupilumab-naïve

Triamcinolone Acetonide

Clinical Study ID

NCT05436535
DAIT ADRN-12
  • Ages > 6
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

All Participants:

  1. Participant and/or parent guardian must be able to understand and provide informedconsent 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 topicalmoisturizer (Vanicream (TM)) at least twice daily between the Baseline Assessmentand Day 7 Visits to a specified skin target area

  4. Individuals with asthma must adhere to asthma controller medication(s) for theduration 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 ifthey 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:

  7. Willing to remain abstinent from intercourse that may result in pregnancy.

  8. Willing to use Food and Drug Administration (FDA) approved methods ofcontraception for the duration of the study

  9. Participant and/or parent guardian must be able to understand and completestudy-related questionnaires.

  10. Participants must have adequate sizes of non-lesional skin on extremities or trunk. Non-Atopic dermatitis (AD) Participants:

  11. No history of AD or food allergy as diagnosed by a physician All AD Participants (DNAD and LTD):

  12. DNAD and LTD participants must have a history of chronic AD, (according to theAtopic Dermatitis Research Network [ADRN] Standard Diagnostic Criteria [AppendixB]), that has been present for at least 1 year before the Screening Visit.

  13. Must agree to refrain from applying topical steroid to a specified target areabetween the Baseline Assessment and Day 7 Visit DNAD Participants:

  14. DNAD participants must have active lesions on the upper or lower extremities ortrunk of sufficient size and in the required locations, as specified in the studymanual of procedures (MOP), for specimen collection at the Baseline Assessment andSteroid Initiation (Day 7) Visits. LTD Participants:

  15. Long-term dupilumab participants must be currently receiving dupilumab and must havestarted dupilumab treatment >= 4 months prior to the Screening Visit

Exclusion

Exclusion Criteria:

  1. Inability or unwillingness of a participant or parent guardian to comply with studyprotocol

  2. Have a genetic relative (e.g., parent, sibling, grandchild, half-sibling) orhousehold 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 thestratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous T celllymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitisherpetiformis, Hailey-Hailey, or Darier's disease)

  6. Known or suspected immunosuppression, including history of invasive opportunisticinfections (e.g. tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis,pneumocystis, aspergillosis) despite infection resolution, or otherwise recurrentimmune-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 theindividual's risk for study participation. Examples include, but are not limited to,individuals with a history of or active case of herpes keratitis; Sjogren'sSyndrome, Keratoconjunctivitis Sicca, or Dry Eye Syndrome that require daily use ofsupplemental lubrication; or individuals with ocular conditions that require theregular use of ocular corticosteroids or cyclosporine

  9. Parasitic infection, except for vaginal trichomoniasis, within 12 months of theScreening Visit, or high risk for contracting parasitic infections (e.g. living inor traveling to endemic areas)

  10. History of malignancy within 5 years before the Screening Visit (completely treatedin situ carcinoma of the cervix, and completely treated and resolved non-metastaticsquamous or basal cell carcinoma of the skin or melanoma in situ are notexclusionary)

  11. History of non-malignant lymphoproliferative disorders

  12. History of alcohol or drug abuse within 2 years before the Screening Visit

  13. History of keloid formation (exclusionary for adult participants only)

  14. History of hypersensitivity to local anesthetics (e.g., lidocaine or Novocain),bleeding disorders, or treatment with anticoagulants or other conditions in adultparticipants that would make the biopsy procedure inadvisable

  15. History of serious life-threatening reaction to tape or adhesives

  16. Individuals with asthma who have required use of a systemic corticosteroid within 3months prior to the Baseline Assessment Visit or who require a dose greater than 880mcg/day of fluticasone propionate or equivalent inhaled corticosteroid to maintainasthma control.

  17. Planned major surgical procedure during study participation that could affect studyparticipation or outcome assessment, per PI discretion

  18. Chronic or acute infection requiring treatment with systemic antibiotics,antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before theBaseline Assessment Visit, or superficial skin infection within 1 week before theBaseline Assessment Visit

  19. Pregnant or breast-feeding women, or women planning to become pregnant or breastfeedduring the study

  20. Use of any systemic (oral, intravenous (IV), intramuscular (IM))immunosuppressive/immunomodulating therapies (e.g. steroids, cyclosporine, Januskinase inhibitors, mycophenolate, azathioprine, or methotrexate) within 4 Weeks ofthe Baseline Assessment Visit, or any condition that, in the opinion of theinvestigator, will likely require such treatment(s) during study participation

  21. Treatment with biologics (other than dupilumab) as follows:

  22. Any cell-depleting agents, including but not limited to rituximab, within 6months before the Baseline Assessment Visit, or until lymphocyte and CD 19+lymphocyte count returns to normal, whichever is longer

  23. Omalizumab, Infliximab, adalimumab, golimumab, certolizumab pegol, abatacept,etanercept, anakinra within 16 weeks before the Baseline Assessment Visit forany indication

  24. Other biologics within 5 half-lives (if known) or 16 weeks before the BaselineAssessment Visit, whichever is longer

  25. Treatment with a live (attenuated) vaccine within 7 weeks before the BaselineAssessment Visit or planning to receive a live vaccine during the study

  26. Ongoing participation in another research study involving any of the following:

  27. Current or planned use of an investigational drug or device.

  28. Current or planned use of prohibited medications or procedures

  29. Substantial time commitment and/or study requirements that may interfere withthe participant's ability to comply with LEADS study requirements

  30. Use of investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the Baseline Assessment Visit

  31. Use of topical calcineurin inhibitors (tacrolimus or pimecrolimus), topicalphosphodiesterase inhibitors (crisaborale), or topical JAK inhibitors (ruxolitinib)within 1 week before the Baseline Assessment Visit

  32. Use of phototherapy (such as narrowband ultraviolet B [NBUVB], ultraviolet B [UVB],ultraviolet A1 [UVA1], psoralen + UVA [PUVA]) or a tanning booth/parlor within 4weeks of the Baseline Assessment Visit.

  33. Treatment with bleach bath within 1 week before the Baseline Assessment Visit

  34. Use of a chlorinated hot tub within 1 week before the Baseline Assessment Visit

  35. Initiation of treatment with prescription moisturizers or moisturizers containingceramide, hyaluronic acid, urea, or filaggrin (FLG) during the study period (participants may continue using stable doses of such moisturizers on body areasother than the target area if initiated before the Baseline Assessment Visit)

  36. Participants may continue using stable doses of such moisturizers on body areasother than the target area if initiated before the Baseline Assessment.

  37. Initiation of prescription moisturizer is not exclusionary when only applied tothe face, neck, palms, or soles.

  38. Planned or anticipated use of any prohibited medications or procedures during studyparticipation.

  39. Past or current medical problems or findings from physical examination that are notlisted above, which, in the opinion of the investigator, may pose additional risksfrom participation in the study, may interfere with the participant's ability tocomply with study requirements or that may impact the quality or interpretation ofthe data obtained from the study.

Study Design

Total Participants: 433
Treatment Group(s): 7
Primary Treatment: Dupilumab
Phase: 4
Study Start date:
November 21, 2022
Estimated Completion Date:
October 30, 2025

Connect with a study center

  • University of California, San Diego: Dermatology Clinical Trials Unit

    La Jolla, California 92093
    United States

    Site Not Available

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

    Los Angeles, California 90027
    United States

    Site Not Available

  • National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

    Denver, Colorado 80206
    United States

    Site Not Available

  • Boston Children's Hospital: Department of Immunology

    Boston, Massachusetts 02215
    United States

    Site Not Available

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

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester Medical Center: Department of Dermatology

    Rochester, New York 14642
    United States

    Site Not Available

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

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center: Asthma Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Oregon Health & Science University: Department of Dermatology

    Portland, Oregon 97239
    United States

    Site Not Available

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

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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