Atopic DermatitisNCT05598762
The Transcriptomic Study of Thai Patients With Atopic Dermatitis by Tape Strips
A study testing Tape strips in people with Atopic Dermatitis, run by Queen Sirikit National Institute of Child Health at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 1 year to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Tape strips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Active skin infections
- Used systemic immunosuppressants within 4 weeks
- Used topical steroids or immunomodulators within 1 week
- Used moisturizers within 12 hours before evaluation
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Sirikit National Institute of Child Health
Bangkok, 10400
About this study
This study will be use the tape strip technique to evaluate the skin biomarkers of atopic dermatitis among Thai patients to differentiate clinical phenotype.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Tape strips
- Keywords
- tape strips, endotype
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tape stripsGenetic
Tape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis.
| Study group | Role | What they receive |
|---|---|---|
| Children with mild atopic dermatitis | Active comparator | * age 1-8 years old
* mild degree of atopic dermatitis Receives: Genetic: Tape strips |
| Children with moderate-severe atopic dermatitis | Active comparator | * age 1-8 years old
* moderate or severe degree of atopic dermatitis Receives: 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 Receives: Genetic: Tape strips |
| Adult with atopic dermatitis | Active comparator | * age 18-60 years old
* mild-severe atopic dermatitis Receives: Genetic: Tape strips |
| Healthy | Active comparator | * age 1-60 years old
* no history of atopic diseases Receives: Genetic: Tape strips |
| Healthy with Asthma | Active comparator | * age 1-8 years old
* doctor diagnosed asthma
* no history of chronic or chronic relapsing eczema Receives: Genetic: Tape strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study startDec 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Sirikit National Institute of Child Health
- Sponsor type
- Other government
- Collaborators
- Mahidol University, Icahn School of Medicine at Mount Sinai, Samitivej Hospital group
- Responsible party
- Principal investigator, Tassalapa Daengsuwan, Queen Sirikit National Institute of Child Health
- Investigators
- Panipak Temboonnark, MD, Principal investigator, Queen Sirikit National Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598762
- Sponsor's protocol ID
- 65-007
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30612663Brunner 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.
PubMed 30465859Chan 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.
PubMed 29964056Guttman-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.
PubMed 31596431
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transcriptomic Study of Thai Patients With Atopic Dermatitis by Tape Strips
- ClinicalTrials.gov ID
- NCT05598762
- Acronym / sponsor ID
- 65-007
- Conditions
- Atopic Dermatitis
- Keywords
- tape strips, endotype
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Queen Sirikit National Institute of Child HealthOther government
- Collaborators
- Mahidol University, Icahn School of Medicine at Mount Sinai, Samitivej Hospital group
- Study start
- Dec 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Children with mild atopic dermatitis | Active comparator | Genetic: Tape strips* age 1-8 years old * mild degree of atopic dermatitis |
| Children with moderate-severe atopic dermatitis | Active comparator | Genetic: Tape strips* age 1-8 years old * moderate or severe degree of atopic dermatitis |
| Children with food allergy and moderate-severe atopic dermatitis | Active comparator | Genetic: Tape strips* age 1-8 years old * moderate or severe degree of atopic dermatitis * IgE mediated food allergy |
| Adult with atopic dermatitis | Active comparator | Genetic: Tape strips* age 18-60 years old * mild-severe atopic dermatitis |
| Healthy | Active comparator | Genetic: Tape strips* age 1-60 years old * no history of atopic diseases |
| Healthy with Asthma | Active comparator | Genetic: Tape strips* age 1-8 years old * doctor diagnosed asthma * no history of chronic or chronic relapsing eczema |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- Active skin infections
- Used systemic immunosuppressants within 4 weeks
- Used topical steroids or immunomodulators within 1 week
- Used moisturizers within 12 hours before evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tape stripsTape strip is a minimally invasive method that captures the stratum corneum. It is use to identify skin biomarkers in atopic dermatitis. | Genetic | Adult with atopic dermatitis, Children with food allergy and moderate-severe atopic dermatitis, Children with mild atopic dermatitis, Children with moderate-severe atopic dermatitis, Healthy, Healthy with Asthma |
Primary outcome
Cellular AD biomarkers
Time frame: 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
Immune biomarkers
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Results publication: PubMed 30612663Czarnowicki 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 publication: PubMed 30465859Brunner 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 publication: PubMed 29964056Chan 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 publication: PubMed 31596431Guttman-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.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingObservational study
Observational Analytical Validation Study of the Replior ScratchSense
Atopic Dermatitis, Pruritus
Active, not recruitingPhase 2
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panipak Temboonnark, MD principal investigator
Queen Sirikit National Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tape strips in people with Atopic Dermatitis, run by Queen Sirikit National Institute of Child Health at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panipak Temboonnark, MD (+1929-823-2424, panipak.ny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular AD biomarkers (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598762, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.