Back to resultsThe Transcriptomic Study of Thai Patients With Atopic Dermatitis by Tape Strips
Primary Purpose
Atopic Dermatitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Tape strips
Sponsored by
About this trial
This is an interventional basic science trial for Atopic Dermatitis focused on measuring tape strips, endotype
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
Sites / Locations
- Queen Sirikit National Institute of Child Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Children with mild atopic dermatitis
Children with moderate-severe atopic dermatitis
Children with food allergy and moderate-severe atopic dermatitis
Adult with atopic dermatitis
Healthy
Healthy with Asthma
Arm Description
age 1-8 years old mild degree of atopic dermatitis
age 1-8 years old moderate or severe degree of atopic dermatitis
age 1-8 years old moderate or severe degree of atopic dermatitis IgE mediated food allergy
age 18-60 years old mild-severe atopic dermatitis
age 1-60 years old no history of atopic diseases
age 1-8 years old doctor diagnosed asthma no history of chronic or chronic relapsing eczema
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05598762
First Posted
October 25, 2022
Last Updated
November 1, 2022
Sponsor
Queen Sirikit National Institute of Child Health
Collaborators
Mahidol University, Icahn School of Medicine at Mount Sinai, Samitivej Hospital group
1. Study Identification
Unique Protocol Identification Number
NCT05598762
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Sirikit National Institute of Child Health
Collaborators
Mahidol University, Icahn School of Medicine at Mount Sinai, Samitivej Hospital group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
tape strips, endotype
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children with mild atopic dermatitis
Arm Type
Active Comparator
Arm Description
age 1-8 years old
mild degree of atopic dermatitis
Arm Title
Children with moderate-severe atopic dermatitis
Arm Type
Active Comparator
Arm Description
age 1-8 years old
moderate or severe degree of atopic dermatitis
Arm Title
Children with food allergy and moderate-severe atopic dermatitis
Arm Type
Active Comparator
Arm Description
age 1-8 years old
moderate or severe degree of atopic dermatitis
IgE mediated food allergy
Arm Title
Adult with atopic dermatitis
Arm Type
Active Comparator
Arm Description
age 18-60 years old
mild-severe atopic dermatitis
Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
age 1-60 years old
no history of atopic diseases
Arm Title
Healthy with Asthma
Arm Type
Active Comparator
Arm Description
age 1-8 years old
doctor diagnosed asthma
no history of chronic or chronic relapsing eczema
Intervention Type
Genetic
Intervention Name(s)
Tape strips
Intervention Description
Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.
Primary Outcome Measure Information:
Title
Cellular AD biomarkers
Description
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
Time Frame
1 month
Title
Immune biomarkers
Description
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
Time Frame
1 month
Title
Barrier biomarkers
Description
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
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panipak Temboonnark, MD
Phone
+1929-823-2424
Email
panipak.ny@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tassalapa Daengsuwan, MD
Phone
+668-1822-1368
Email
tassalapa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panipak Temboonnark, MD
Organizational Affiliation
Queen Sirikit National Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Sirikit National Institute of Child Health
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30612663
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.
Results Reference
result
PubMed Identifier
30465859
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.
Results Reference
result
PubMed Identifier
29964056
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.
Results Reference
result
PubMed Identifier
31596431
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.
Results Reference
result
Learn more about this trial
The Transcriptomic Study of Thai Patients With Atopic Dermatitis by Tape Strips
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