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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05598762
• Other study ID #: 65-007
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2022
• Source: Queen Sirikit National Institute of Child Health
• Contact: Panipak Temboonnark, MD
• Phone: +1929-823-2424
• Email: panipak.ny[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
Thailand	Queen Sirikit National Institute of Child Health	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
Queen Sirikit National Institute of Child Health	Icahn School of Medicine at Mount Sinai, Mahidol University, Samitivej Hospital group

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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. Review. — View 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 T(H)2/T(H)17 skewing with psoriasiform features. J Allergy Clin Immunol. 2018 Sep; — View 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. Review. — View 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 Ato — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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