| Eligibility |
Inclusion Criteria:
All Participants:
1. Participant and/or parent guardian must be able to understand and provide informed
consent and assent (if applicable)
2. 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
3. Individuals with asthma must adhere to asthma controller medication(s) for the
duration of the study
4. Females of child-bearing potential who do not self-report as pregnant must have a
negative pregnancy test at the Baseline Assessment and Day 7 Visits.
5. Females of child-bearing and sexually active must agree to use Food and Drug
Administration (FDA) approved methods of birth control for the duration of the study.
These include hormonal contraceptives, intrauterine device, double barrier
contraception (i.e., condom plus diaphragm), or male partner with documented vasectomy
6. Participant and/or parent guardian must be able to understand and complete
study-related questionnaires
Non-Atopic dermatitis (AD) Participants:
1. No history of AD or food allergy as diagnosed by a physician
AD Participants:
1. A history of Chronic AD, (according to the Atopic Dermatitis Research Network [ADRN]
Standard Diagnostic Criteria), that has been present for at least 1 year before the
Screening Visit
2. Must agree to refrain from applying topical steroid to a specified target area between
the Baseline Assessment and Day 7 Visit
3. Dupilumab-naïve AD participants must have active lesions on the upper or lower
extremities or trunk of sufficient size (36 cm^2 area for participants >= 18 years of
age, and 32 cm^ 2 for participants < 18 years of age) for specimen collection at the
Baseline Assessment and at the Steroid Initiation (Day 7) Visits. The required area
may be one contiguous area or may encompass multiple areas
4. Long-term dupilumab participants must be currently receiving dupilumab and must have
started dupilumab treatment >= 4 months prior to the Screening Visit
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)
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 serious life-threatening reaction to tape or adhesives
15. 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
16. 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. This includes hypersensitivity to local anesthetics
(e.g., lidocaine or Novocain), bleeding disorders, treatment with anticoagulants or
other conditions in adult participants that would make the biopsy procedure
inadvisable
17. Planned major surgical procedure during study participation that could affect study
participation 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 the Baseline
Assessment Visit, or superficial skin infection within 1 week before the Baseline
Assessment Visit
19. Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed
during the study
20. 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
21. Treatment with biologics (other than dupilumab) as follows:
1. 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
2. Omalizumab, Infliximab, adalimumab, golimumab, certolizumab pegol, abatacept,
etanercept, anakinra within 16 weeks before the Baseline Assessment Visit for any
indication
3. Other biologics within 5 half-lives (if known) or 16 weeks before the Baseline
Assessment Visit, whichever is longer
22. Treatment with a live (attenuated) vaccine within 6 weeks before the Baseline
Assessment Visit or planning to receive a live vaccine during the study
23. Ongoing participation in an investigational trial or use of an investigational drug
within 8 weeks or within 5 half-lives (if known), whichever is longer, before the
Baseline Assessment Visit
24. 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
25. 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.
26. Treatment with bleach bath within 1 week before the Baseline Assessment Visit
27. Use of a chlorinated hot tub within 1 week before the Baseline Assessment Visit
28. 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)
29. Planned or anticipated use of any prohibited medications or procedures during study
participation.
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