NCT05598762

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

October 25, 2022

Last Update Submit

November 1, 2022

Conditions

Atopic Dermatitis

Keywords

tape stripsendotype

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (6)

Children with mild atopic dermatitis

ACTIVE COMPARATOR

* age 1-8 years old * mild degree of atopic dermatitis

Genetic: Tape strips

Children with moderate-severe atopic dermatitis

ACTIVE COMPARATOR

* age 1-8 years old * moderate or severe degree of atopic dermatitis

Genetic: Tape strips

Children with food allergy and moderate-severe atopic dermatitis

ACTIVE COMPARATOR

* age 1-8 years old * moderate or severe degree of atopic dermatitis * IgE mediated food allergy

Genetic: Tape strips

Adult with atopic dermatitis

ACTIVE COMPARATOR

* age 18-60 years old * mild-severe atopic dermatitis

Genetic: Tape strips

Healthy

ACTIVE COMPARATOR

* age 1-60 years old * no history of atopic diseases

Genetic: Tape strips

Healthy with Asthma

ACTIVE COMPARATOR

* age 1-8 years old * doctor diagnosed asthma * no history of chronic or chronic relapsing eczema

Genetic: Tape strips

Interventions

Tape stripsGENETIC

Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.

Adult with atopic dermatitisChildren with food allergy and moderate-severe atopic dermatitisChildren with mild atopic dermatitisChildren with moderate-severe atopic dermatitisHealthyHealthy with Asthma

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Sirikit National Institute of Child Health

Bangkok, 10400, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 30612663RESULT

  • 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.

    PMID: 30465859RESULT

  • 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.

    PMID: 29964056RESULT

  • 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.

    PMID: 31596431RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Panipak Temboonnark, MD

    Queen Sirikit National Institute of Child Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Panipak Temboonnark, MD

CONTACT

+1929-823-2424panipak.ny@gmail.com

Tassalapa Daengsuwan, MD

CONTACT

+668-1822-1368tassalapa@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

December 1, 2022

Primary Completion

May 1, 2023

Study Completion

July 1, 2024

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)