Last updated: March 1, 2021
Sponsor: National Jewish Health
Overall Status: Active - Recruiting
Phase
N/A
Condition
Atopic Dermatitis
Dermatitis, Atopic
Eczema (Atopic Dermatitis)
Treatment
N/AClinical Study ID
NCT04525521
HS 0720
3030005053
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Inclusion criteria of the AD group:
• Individuals with atopic dermatitis, ages 18-60 years old. Inclusion criteria of the non-atopic group, ages 18-60 years old:
• Individuals with no history of atopic dermatitis, contact dermatitis, food allergy,asthma, or allergic rhinitis.
Exclusion
Exclusion Criteria: Exclusion criteria of all subjects:
- Subject has taken systemic immunosuppressive drugs including oral steroids within 30days of skin barrier assessment
- Subject has received immunotherapy in the past year
- Subject has received any biologic medications within 5 half-lives or 16 weeks,whichever is longer
- Subject has received any investigational drugs within 5 half-lives or 8 weeks,whichever is longer
- Subject has taken anti-anxiety, antidepressant, or anticoagulant medications in thelast 30 days
- Subject has received total body phototherapy (e.g., ultraviolet light B [UVB],psoralen plus ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30days of skin barrier assessment
- Subject has used topical corticosteroids, topical immunomodulatory agents, or topicalantibiotics on the extremity being evaluated within 7 days of skin barrier assessment
- Subject has a severe concurrent disease or immunosuppression
- Subject has a history of a severe reaction to latex, tape, or adhesives
- Subject is pregnant or lactating For the medications below, they have to be temporarily withheld before participation in thestudy:
- If the subject is taking oral antihistamines, they will need to be withheld for fivedays prior to the skin barrier study.
- If the subject is taking oral antibiotics, antivirals, antifungals, or antiparasitics,the skin barrier studies can be scheduled seven days after the last dose has beentaken.
- If the subject is taking topical medications including (but not restricted to) Elidel,Protopic, topical corticosteroids and topical antibiotics, they will need to bewithheld on the hand being evaluated seven days prior to the skin barrier studies.Moisturizers will also need to be withheld on the area 24 hours prior to the visit.The subject cannot have taken a bleach bath within 7 days of the visit, and thesubject cannot take a bath or shower on the day of the visit.
Study Design
Total Participants: 40
Study Start date:
December 01, 2020
Estimated Completion Date:
August 20, 2021
Study Description
Connect with a study center
National Jewish Health
Denver, Colorado 80206
United StatesActive - Recruiting
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