Clinical trial NCT05598762: The Transcriptomic Study of Thai Patients With Atopic Dermatitis by Tape Strips
Official title: The Transcriptomic Study of Thai Patients With Atopic Dermatitis by Tape Strips
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Keywords: tape strips
endotype
Lead sponsor: Queen Sirikit National Institute of Child Health
Sponsor class: OTHER_GOV
Collaborators: name: Mahidol University
name: Icahn School of Medicine at Mount Sinai
name: Samitivej Hospital group
First posted: 2022-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will be use the tape strip technique to evaluate the skin biomarkers of atopic dermatitis among Thai patients to differentiate clinical phenotype.

Detailed description: The patients will be enrolled in this study if they have been diagnosed with atopic dermatitis. All participants (AD patients and controls) will be evaluated their skin biomarkers by using tape stripping. The tape strips will be applied to the antecubital fossa to collect the epithelial samples. Then RNA was extracted from the tape strips for mRNA profiling to identify the immune and epidermal barrier genes.

Eligibility criteria: Inclusion Criteria:

* Children (age 1-18 years old) with mild atopic dermatitis
* Children (age 1-18 years old) with moderate to severe atopic dermatitis
* Children (age 1-18 years old) with moderate to severe atopic dermatitis and food allergy
* Adult (age 18-60 years old) with atopic dermatitis
* Healthy individuals (1-60 years old)
* Patients with asthma (1-60 years old)

Exclusion Criteria:

* Active skin infections
* Used systemic immunosuppressants within 4 weeks
* Used topical steroids or immunomodulators within 1 week
* Used moisturizers within 12 hours before evaluation

Primary outcomes:
measure: Cellular AD biomarkers
timeFrame: 1 month
measure: Immune biomarkers
timeFrame: 1 month
measure: Barrier biomarkers
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
Study officials:
affiliation: Queen Sirikit National Institute of Child Health
name: Panipak Temboonnark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Czarnowicki T, He H, Krueger JG, Guttman-Yassky E. Atopic dermatitis endotypes and implications for targeted therapeutics. J Allergy Clin Immunol. 2019 Jan;143(1):1-11. doi: 10.1016/j.jaci.2018.10.032.
citation: Brunner PM, Guttman-Yassky E. Racial differences in atopic dermatitis. Ann Allergy Asthma Immunol. 2019 May;122(5):449-455. doi: 10.1016/j.anai.2018.11.015. Epub 2018 Nov 20.
citation: Chan TC, Sanyal RD, Pavel AB, Glickman J, Zheng X, Xu H, Cho YT, Tsai TF, Wen HC, Peng X, Cueto I, Krueger JG, Guttman-Yassky E. Atopic dermatitis in Chinese patients shows TH2/TH17 skewing with psoriasiform features. J Allergy Clin Immunol. 2018 Sep;142(3):1013-1017. doi: 10.1016/j.jaci.2018.06.016. Epub 2018 Jun 28. No abstract available.
citation: Guttman-Yassky E, Diaz A, Pavel AB, Fernandes M, Lefferdink R, Erickson T, Canter T, Rangel S, Peng X, Li R, Estrada Y, Xu H, Krueger JG, Paller AS. Use of Tape Strips to Detect Immune and Barrier Abnormalities in the Skin of Children With Early-Onset Atopic Dermatitis. JAMA Dermatol. 2019 Dec 1;155(12):1358-1370. doi: 10.1001/jamadermatol.2019.2983.