Phase
Condition
Dermatitis, Atopic
Skin Infections/disorders
Eczema (Atopic Dermatitis)
Treatment
Dupilumab
Vanicream- Dupilumab-naïve
Triamcinolone Acetonide
Clinical Study ID
Ages > 6 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All Participants:
Participant and/or parent guardian must be able to understand and provide informedconsent 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 topicalmoisturizer (Vanicream (TM)) at least twice daily between the Baseline Assessmentand Day 7 Visits to a specified skin target area
Individuals with asthma must adhere to asthma controller medication(s) for theduration 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 ifthey do not self-report as pregnant.
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 ofcontraception for the duration of the study
Participant and/or parent guardian must be able to understand and completestudy-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 theAtopic Dermatitis Research Network [ADRN] Standard Diagnostic Criteria [AppendixB]), 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 areabetween the Baseline Assessment and Day 7 Visit DNAD Participants:
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:
Long-term dupilumab participants must be currently receiving dupilumab and must havestarted dupilumab treatment >= 4 months prior to the Screening Visit
Exclusion
Exclusion Criteria:
Inability or unwillingness of a participant or parent guardian to comply with studyprotocol
Have a genetic relative (e.g., parent, sibling, grandchild, half-sibling) orhousehold 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 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)
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
Known history of human immunodeficiency virus (HIV) infection
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
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)
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)
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 adultparticipants 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 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.
Planned major surgical procedure during study participation that could affect studyparticipation or outcome assessment, per PI discretion
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
Pregnant or breast-feeding women, or women planning to become pregnant or breastfeedduring the study
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
Treatment with biologics (other than dupilumab) as follows:
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
Omalizumab, Infliximab, adalimumab, golimumab, certolizumab pegol, abatacept,etanercept, anakinra within 16 weeks before the Baseline Assessment Visit forany indication
Other biologics within 5 half-lives (if known) or 16 weeks before the BaselineAssessment Visit, whichever is longer
Treatment with a live (attenuated) vaccine within 7 weeks before the BaselineAssessment 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 withthe 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), topicalphosphodiesterase 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 4weeks 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 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)
Participants may continue using stable doses of such moisturizers on body areasother than the target area if initiated before the Baseline Assessment.
Initiation of prescription moisturizer is not exclusionary when only applied tothe face, neck, palms, or soles.
Planned or anticipated use of any prohibited medications or procedures during studyparticipation.
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
Connect with a study center
University of California, San Diego: Dermatology Clinical Trials Unit
La Jolla, California 92093
United StatesSite Not Available
Children's Hospital Los Angeles: Division of Clinical Immunology & Allergy
Los Angeles, California 90027
United StatesSite Not Available
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Denver, Colorado 80206
United StatesSite Not Available
Boston Children's Hospital: Department of Immunology
Boston, Massachusetts 02215
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
New York, New York 10029
United StatesSite Not Available
University of Rochester Medical Center: Department of Dermatology
Rochester, New York 14642
United StatesSite Not Available
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio 45229
United StatesSite Not Available
Oregon Health & Science University: Department of Dermatology
Portland, Oregon 97239
United StatesSite Not Available
University of Pennsylvania, Perelman Center for Advanced Medicine: Department of Dermatology
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
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