Atopic DermatitisPhase 4LEADSNCT05436535
Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
A Phase 4 study testing Dupilumab, Vanicream- Dupilumab-naïve and Triamcinolone Acetonide in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab, Vanicream- Dupilumab-naïve and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 10 sitesUnited States
- Study dates
- 21 Nov 2022to 24 Oct 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All Participants:
- Participant and/or parent guardian must be able to understand and provide informed consent and assent (if applicable)
- Male or female, 6 years of age or older inclusive at the Screening Visit
- 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
- Individuals with asthma must adhere to asthma controller medication(s) for the duration of the study
- 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.
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- Individuals who can become pregnant, as defined in the study manual of procedures, must meet either of the following criteria prior to Baseline Assessment:
- Willing to remain abstinent from intercourse that may result in pregnancy.
- Willing to use Food and Drug Administration (FDA) approved methods of contraception for the duration of the study
- Participant and/or parent guardian must be able to understand and complete study-related questionnaires.
- Participants must have adequate sizes of non-lesional skin on extremities or trunk.
- Non-Atopic dermatitis (AD) Participants:
- No history of AD or food allergy as diagnosed by a physician
- All AD Participants (DNAD and LTD):
- DNAD and LTD participants must have a history of chronic AD, (according to the Atopic Dermatitis Research Network [ADRN] Standard Diagnostic Criteria [Appendix B]), that has been present for at least 1 year before the Screening Visit.
- Must agree to refrain from applying topical steroid to a specified target area between the Baseline Assessment and Day 7 Visit
- DNAD Participants:
- DNAD participants must have active lesions on the upper or lower extremities or trunk of sufficient size and in the required locations, as specified in the study manual of procedures (MOP), for specimen collection at the Baseline Assessment and Steroid Initiation (Day 7) Visits.
- LTD Participants:
- Long-term dupilumab participants must be currently receiving dupilumab and must have started dupilumab treatment >= 4 months prior to the Screening Visit
Who cannot join
- Inability or unwillingness of a participant or parent guardian to comply with study protocol
- Have a genetic relative (e.g., parent, sibling, grandchild, half-sibling) or household member (e.g., spouse) already enrolled in the study
- Weight less than 15 kg
- Known systemic hypersensitivity to any of the excipients of the study treatments (Vanicream (TM), hydrocortisone, triamcinolone, or dupilumab)
- 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)
- 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
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- Known history of human immunodeficiency virus (HIV) infection
- 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
- 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)
- 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)
- History of non-malignant lymphoproliferative disorders
- History of alcohol or drug abuse within 2 years before the Screening Visit
- History of keloid formation (exclusionary for adult participants only)
- History of hypersensitivity to local anesthetics (e.g., lidocaine or Novocain), bleeding disorders, or treatment with anticoagulants or other conditions in adult participants that would make the biopsy procedure inadvisable
- History of serious life-threatening reaction to tape or adhesives
- Individuals with asthma who have required use of a systemic corticosteroid within 3 months prior to the Baseline Assessment Visit or who require a dose greater than 880 mcg/day of fluticasone propionate or equivalent inhaled corticosteroid to maintain asthma control.
- Planned major surgical procedure during study participation that could affect study participation or outcome assessment, per PI discretion
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the Baseline Assessment Visit, or superficial skin infection within 1 week before the Baseline Assessment Visit
- Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed during the study
- Use of any systemic (oral, intravenous (IV), intramuscular (IM)) immunosuppressive/immunomodulating therapies (e.g. steroids, cyclosporine, Janus kinase inhibitors, mycophenolate, azathioprine, or methotrexate) within 4 Weeks of the Baseline Assessment Visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during study participation
- Treatment with biologics (other than dupilumab) as follows:
- Any cell-depleting agents, including but not limited to rituximab, within 6 months before the Baseline Assessment Visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
- Omalizumab, Infliximab, adalimumab, golimumab, certolizumab pegol, abatacept, etanercept, anakinra within 16 weeks before the Baseline Assessment Visit for any indication
- Other biologics within 5 half-lives (if known) or 16 weeks before the Baseline Assessment Visit, whichever is longer
- Treatment with a live (attenuated) vaccine within 7 weeks before the Baseline Assessment Visit or planning to receive a live vaccine during the study
- Ongoing participation in another research study involving any of the following:
- Current or planned use of an investigational drug or device.
- Current or planned use of prohibited medications or procedures
- Substantial time commitment and/or study requirements that may interfere with the participant's ability to comply with LEADS study requirements
- Use of investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the Baseline Assessment Visit
- Use of topical calcineurin inhibitors (tacrolimus or pimecrolimus), topical phosphodiesterase inhibitors (crisaborale), or topical JAK inhibitors (ruxolitinib) within 1 week before the Baseline Assessment Visit
- Use of phototherapy (such as narrowband ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + UVA [PUVA]) or a tanning booth/parlor within 4 weeks of the Baseline Assessment Visit.
- Treatment with bleach bath within 1 week before the Baseline Assessment Visit
- Use of a chlorinated hot tub within 1 week before the Baseline Assessment Visit
- Initiation of treatment with prescription moisturizers or moisturizers containing ceramide, hyaluronic acid, urea, or filaggrin (FLG) during the study period (participants may continue using stable doses of such moisturizers on body areas other than the target area if initiated before the Baseline Assessment Visit)
- Participants may continue using stable doses of such moisturizers on body areas other than the target area if initiated before the Baseline Assessment.
- Initiation of prescription moisturizer is not exclusionary when only applied to the face, neck, palms, or soles.
- Planned or anticipated use of any prohibited medications or procedures during study participation.
- Past or current medical problems or findings from physical examination that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Boston Children's Hospital: Department of Immunology
Boston, Massachusetts, 02215
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio, 45229
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Denver, Colorado, 80206
University of California, San Diego: Dermatology Clinical Trials Unit
La Jolla, California, 92093
Children's Hospital Los Angeles: Division of Clinical Immunology & Allergy
Los Angeles, California, 90027
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
New York, New York, 10029
University of Pennsylvania, Perelman Center for Advanced Medicine: Department of Dermatology
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University: Department of Dermatology
Portland, Oregon, 97239
University of Rochester Medical Center: Department of Dermatology
Rochester, New York, 14642
About this study
Official title: Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis (ADRN-12)
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide, Hydrocortisone, Vanicream- Active
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabBiological
Also called Dupixent
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).
Vanicream- Dupilumab-naïveDrug
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.
Triamcinolone AcetonideDrug
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.
HydrocortisoneDrug
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.
Vanicream- ActiveDrug
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.
Vanicream- Experienced DupilumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab-naïve atopic dermatitis participants | Experimental | On Day 7, approximately 390 dupilumab-naïve AD participants (including approximately 130 children and 260 adults) will begin applying topical corticosteroids twice daily to their specified target area, as well as to active lesions on non-target skin.
Dupilumab-naïve AD participants will return for a Steroid Assessment Visit at Day 35, when response to topical corticosteroids will be evaluated at the target site by TAA and targeted EASI scoring, and overall management of AD body-wide by topical steroid/moisturizer treatment will be evaluated by EASI score.
Participants who are responsive to topical corticosteroids will continue to use them body-wide through Day 140. Participants who are non-responsive to topical corticosteroids at any time before Day 91 will begin use of dupilumab through their penultimate scheduled visit (Day 140-Day 196) and may continue use of topical corticosteroids outside of their specified target area as needed. Receives: Biological: Dupilumab; Drug: Vanicream- Dupilumab-naïve; Drug: Triamcinolone Acetonide; Drug: Hydrocortisone |
| Experienced Dupilumab atopic dermatitis participants | Experimental | Approximately 60 AD participants already on dupilumab for >= 4 months prior to study entry (including approximately 20 children and 40 adults) at the start of the study will continue treatment with dupilumab as prescribed by their physician outside of the study. They may also continue treatment with other prescribed topical AD medications outside of the specified target skin area throughout the study; they may continue treatment with other prescribed topical AD medications within the specified target area from Day 7 through Day 140.
Long-term dupilumab participants will apply Vanicream™ beginning at Day 0 through Day 7. Long-term dupilumab participants will return for assessment visits at Day 63 and 140. At Day 140, participants will resume application of Vanicream™ through the End of Study Assessment (Day 168). Receives: Drug: Vanicream- Experienced Dupilumab |
| Non-atopic dermatitis participants | Active comparator | Approximately 150 will be non-AD controls (including approximately 50 children and 100 adults) Non-AD control participants will apply Vanicream™ beginning at Day 0 through Day 7. Non-AD control participants will return for assessment visits at Day 35, 91, and 140. At Day 140, participants will resume application of Vanicream™ through the End of Study Assessment (Day 168). Receives: Drug: Vanicream- Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome.
Eczema Area and Severity Index (EASI) is a composite score (range: 0-72) measuring physical signs of atopic dermatitis (AD), including area of involvement and severity. Severity components include: erythema, papulation, excoriation and lichenification [0=absent, 1=mild, 2=moderate, 3=severe] for each body region (head/neck, trunk, arms, legs). Area of involvement (%) is assessed for each body region. Area and severity of each body region is weighted based on size of region, and region scores are added for the total score. Scores ≤7 are considered mild AD severity, >7 are considered moderate-to-severe.
Measured: Day 7
Secondary outcomes (3)
Normalized Gene Counts Expressed in Non-lesional Skin Transcriptome Between Non-AD vs. Mild Dupilumab-naïve AD Adults and Children.
Gene counts are produced by whole transcriptome sequencing (WTS) on the non-lesional skin tape strips collected at Day 7 and Day 168-224 (End of Study). These counts are then normalized by variance stabilizing transformation (VST).
Measured: Day 7, Day 168-224 (End of Study)
Normalized Gene Counts Expressed in Non-lesional Skin Transcriptome Between Non-AD vs. Moderate-to-severe Dupilumab-naïve AD Adults and Children.
Gene counts are produced by whole transcriptome sequencing (WTS) on the non-lesional skin tape strips collected at Day 7 and Day 168-224 (End of Study). These counts are then normalized by variance stabilizing transformation (VST).
Measured: Day 7, Day 168-224 (End of Study)
Change in Normalized Gene Counts Expressed in Non-lesional Skin Transcriptome From Day 7 to Day 168-224 Among Non-AD, Topical Steroid Responders, Dupilumab Responders, Dupilumab Non-Responders, and Long-term Dupilumab AD Adults and Children.
Gene counts are produced by whole transcriptome sequencing (WTS) on the non-lesional skin tape strips collected at Day 7 and Day 168-224 (End of Study). These counts are then normalized by variance stabilizing transformation (VST). The change in normalized gene counts is calculated from Day 7 to Day 168-224 (End of Study) within each group.
Measured: Day 7 and Day 168-224 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start21 Nov 2022
- Primary completion7 Apr 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Donald Leung, M.D., Ph.D., Study chair, National Jewish Health: Division of Pediatric Allergy and Clinical ImmunologyMax A. Seibold, Ph.D., Study chair, National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436535
- Sponsor's protocol ID
- DAIT ADRN-12
- Acronym
- LEADS
- Status last verified
- May 2026
- First submitted
- 21 Jun 2022
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis (ADRN-12)
- ClinicalTrials.gov ID
- NCT05436535
- Acronym / sponsor ID
- LEADS / DAIT ADRN-12
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Posted 4 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dupilumab-naïve atopic dermatitis participants | Experimental | Biological: Dupilumab, Drug: Vanicream- Dupilumab-naïve, Drug: Triamcinolone Acetonide, Drug: HydrocortisoneOn Day 7, approximately 390 dupilumab-naïve AD participants (including approximately 130 children and 260 adults) will begin applying topical corticosteroids twice daily to their specified target area, as well as to active lesions on non-target skin. Dupilumab-naïve AD participants will return for a Steroid Assessment Visit at Day 35, when response to topical corticosteroids will be evaluated at the target site by TAA and targeted EASI scoring, and overall management of AD body-wide by topical steroid/moisturizer treatment will be evaluated by EASI score. Participants who are responsive to topical corticosteroids will continue to use them body-wide through Day 140. Participants who are non-responsive to topical corticosteroids at any time before Day 91 will begin use of dupilumab through their penultimate scheduled visit (Day 140-Day 196) and may continue use of topical corticosteroids outside of their specified target area as needed. |
| Experienced Dupilumab atopic dermatitis participants | Experimental | Drug: Vanicream- Experienced DupilumabApproximately 60 AD participants already on dupilumab for >= 4 months prior to study entry (including approximately 20 children and 40 adults) at the start of the study will continue treatment with dupilumab as prescribed by their physician outside of the study. They may also continue treatment with other prescribed topical AD medications outside of the specified target skin area throughout the study; they may continue treatment with other prescribed topical AD medications within the specified target area from Day 7 through Day 140. Long-term dupilumab participants will apply Vanicream™ beginning at Day 0 through Day 7. Long-term dupilumab participants will return for assessment visits at Day 63 and 140. At Day 140, participants will resume application of Vanicream™ through the End of Study Assessment (Day 168). |
| Non-atopic dermatitis participants | Active comparator | Drug: Vanicream- ActiveApproximately 150 will be non-AD controls (including approximately 50 children and 100 adults) Non-AD control participants will apply Vanicream™ beginning at Day 0 through Day 7. Non-AD control participants will return for assessment visits at Day 35, 91, and 140. At Day 140, participants will resume application of Vanicream™ through the End of Study Assessment (Day 168). |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Participant and/or parent guardian must be able to understand and provide informed consent and assent (if applicable)
- Male or female, 6 years of age or older inclusive at the Screening Visit
- 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
- Individuals with asthma must adhere to asthma controller medication(s) for the duration of the study
- 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.
Key exclusion criteria (39 listed)
- Inability or unwillingness of a participant or parent guardian to comply with study protocol
- Have a genetic relative (e.g., parent, sibling, grandchild, half-sibling) or household member (e.g., spouse) already enrolled in the study
- Weight less than 15 kg
- Known systemic hypersensitivity to any of the excipients of the study treatments (Vanicream (TM), hydrocortisone, triamcinolone, or dupilumab)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentAdult 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). | Biological | Dupilumab-naïve atopic dermatitis participants |
| Vanicream- Dupilumab-naïveDupilumab-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 | Dupilumab-naïve atopic dermatitis participants |
| Triamcinolone AcetonideOn 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 | Dupilumab-naïve atopic dermatitis participants |
| HydrocortisoneOn 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 | Dupilumab-naïve atopic dermatitis participants |
| Vanicream- ActiveNon-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 | Non-atopic dermatitis participants |
| Vanicream- Experienced DupilumabLong-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. | Drug | Experienced Dupilumab atopic dermatitis participants |
Primary outcome
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome.
Time frame: Day 7
Eczema Area and Severity Index (EASI) is a composite score (range: 0-72) measuring physical signs of atopic dermatitis (AD), including area of involvement and severity. Severity components include: erythema, papulation, excoriation and lichenification [0=absent, 1=mild, 2=moderate, 3=severe] for each body region (head/neck, trunk, arms, legs). Area of involvement (%) is assessed for each body region. Area and severity of each body region is weighted based on size of region, and region scores are added for the total score. Scores ≤7 are considered mild AD severity, >7 are considered moderate-to-severe.
3 secondary outcomes
Normalized Gene Counts Expressed in Non-lesional Skin Transcriptome Between Non-AD vs. Mild Dupilumab-naïve AD Adults and Children.
Time frame: Day 7, Day 168-224 (End of Study)
Normalized Gene Counts Expressed in Non-lesional Skin Transcriptome Between Non-AD vs. Moderate-to-severe Dupilumab-naïve AD Adults and Children.
Time frame: Day 7, Day 168-224 (End of Study)
Change in Normalized Gene Counts Expressed in Non-lesional Skin Transcriptome From Day 7 to Day 168-224 Among Non-AD, Topical Steroid Responders, Dupilumab Responders, Dupilumab Non-Responders, and Long-term Dupilumab AD Adults and Children.
Time frame: Day 7 and Day 168-224 (End of Study)
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Allergy and Asthma Clinical Research StudiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Leung, M.D., Ph.D. study chair
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Max A. Seibold, Ph.D. study chair
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab, Vanicream- Dupilumab-naïve and Triamcinolone Acetonide in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome. (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.