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

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Genetic: Tape strips

• Registration Number: NCT05598762
• Lead Sponsor: Queen Sirikit National Institute of Child Health

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.

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-04
• Study Start: 2022-12
• Primary Completion: 2023-05
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children with food allergy and moderate-severe atopic dermatitis	Tape strips	* age 1-8 years old * moderate or severe degree of atopic dermatitis * IgE mediated food allergy
Children with mild atopic dermatitis	Tape strips	* age 1-8 years old * mild degree of atopic dermatitis
Healthy with Asthma	Tape strips	* age 1-8 years old * doctor diagnosed asthma * no history of chronic or chronic relapsing eczema
Adult with atopic dermatitis	Tape strips	* age 18-60 years old * mild-severe atopic dermatitis
Children with moderate-severe atopic dermatitis	Tape strips	* age 1-8 years old * moderate or severe degree of atopic dermatitis
Healthy	Tape strips	* age 1-60 years old * no history of atopic diseases

Primary Outcome Measures

Name	Time	Method
Immune biomarkers	1 month	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
Cellular AD biomarkers	1 month	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
Barrier biomarkers	1 month	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

Trial Locations

Locations (1)

Queen Sirikit National Institute of Child Health; 🇹🇭 Bangkok, Thailand