The Transcriptomic Study of Thai Patients With Atopic Dermatitis by Tape Strips

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

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Genetic: Tape strips

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Panipak Temboonnark, MD; Phone Number: +1929-823-2424; Email: panipak.ny@gmail.com
• Study Contact Backup: Name: Tassalapa Daengsuwan, MD; Phone Number: +668-1822-1368; Email: tassalapa@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Queen Sirikit National Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Children with mild atopic dermatitis; age 1-8 years old; mild degree of atopic dermatitis	Genetic: Tape strips; Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.
Active Comparator: Children with moderate-severe atopic dermatitis; age 1-8 years old; moderate or severe degree of atopic dermatitis	Genetic: Tape strips; Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.
Active Comparator: Children with food allergy and moderate-severe atopic dermatitis; age 1-8 years old; moderate or severe degree of atopic dermatitis; IgE mediated food allergy	Genetic: Tape strips; Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.
Active Comparator: Adult with atopic dermatitis; age 18-60 years old; mild-severe atopic dermatitis	Genetic: Tape strips; Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.
Active Comparator: Healthy; age 1-60 years old; no history of atopic diseases	Genetic: Tape strips; Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.
Active Comparator: Healthy with Asthma; age 1-8 years old; doctor diagnosed asthma; no history of chronic or chronic relapsing eczema	Genetic: Tape strips; Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular AD biomarkers	Evaluated by RNA sequencing: RNA was extracted for real-time polymerase chain reaction (RT-PCR) with the miRNAeasy Mini Kit (Qiagen, Hilden, Germany). Reverse transcription to complementary DNA (cDNA) from RNA was carried out using the High Capacity cDNA reverse transcription (Thermo fisher). TaqMan Low Density Array (TLDA) cards (Thermo fisher) were used for quantitative reverse transcription polymerase chain reaction (qRT-PCR). 500pg total RNA was used for PreAMP pool. Eukaryotic 18S recombinant RNA (rRNA) was used as an endogenous control. Expression values were normalized to Rplp0	1 month
Immune biomarkers	Evaluated by RNA sequencing: RNA was extracted for real-time polymerase chain reaction (RT-PCR) with the miRNAeasy Mini Kit (Qiagen, Hilden, Germany). Reverse transcription to complementary DNA (cDNA) from RNA was carried out using the High Capacity cDNA reverse transcription (Thermo fisher). TaqMan Low Density Array (TLDA) cards (Thermo fisher) were used for quantitative reverse transcription polymerase chain reaction (qRT-PCR). 500pg total RNA was used for PreAMP pool. Eukaryotic 18S recombinant RNA (rRNA) was used as an endogenous control. Expression values were normalized to Rplp0	1 month
Barrier biomarkers	chain reaction (RT-PCR) with the miRNAeasy Mini Kit (Qiagen, Hilden, Germany). Reverse transcription to complementary DNA (cDNA) from RNA was carried out using the High Capacity cDNA reverse transcription (Thermo fisher). TaqMan Low Density Array (TLDA) cards (Thermo fisher) were used for quantitative reverse transcription polymerase chain reaction (qRT-PCR). 500pg total RNA was used for PreAMP pool. Eukaryotic 18S recombinant RNA (rRNA) was used as an endogenous control. Expression values were normalized to Rplp0	1 month

Collaborators and Investigators

• Sponsor: Queen Sirikit National Institute of Child Health
• Collaborators: Icahn School of Medicine at Mount Sinai; Mahidol University; Samitivej Hospital group
• Investigators: Principal Investigator: Panipak Temboonnark, MD, Queen Sirikit National Institute of Child Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: endotype; tape strips
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 65-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No