Dermatitis, AtopicNCT05023668
China Atopic Dermatitis Registry Study
An observational study of Dermatitis, Atopic, run by Peking University People's Hospital at 1 site in China.
Trial summary
This regestry study is aimed to characterize the medical care and drug treatment under real-life conditions among Chinese patients with moderate to severe Atopic Dermatitis who are not well controlled by topical therapies. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis, Atopic
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2021to Oct 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Chinese moderate-to-severe atopic dermatitis patients who are not controlled by topical therapy.
Who may be able to join
- Age≥12;
- AD according to Williams diagnosis criteria (see Appendix 1);
- Moderate to severe AD that inadequately controlled by topical therapy
- Moderate-to-severe: SCORAD score≥25; or
- Inadequately controlled by topic therapies: Determined by physicians.
Who cannot join
- No.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Ping Liu, 010 88325472, llppliuping@126.com
About this study
Official title: China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy
This regestry study is aimed to characterize the medical care and drug treatment under real-life conditions among Chinese patients with moderate to severe Atopic Dermatitis who are not well controlled by topical therapies.
Read the detailed description
Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. A survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland China has shown that the incidence of AD in outpatients (7.8%) has been raised in recent years.
Among topical therapy of AD, corticosteroids are first line therapy. In patients with extensive and severe dermatitis, topical therapy may be insufficient. Such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. There is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. There is not clear recommendation grade for these therapy in Chinese AD guideline and no published data to demonstrate current treatment situation in real clinical practise.
The goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. This study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among AD patients in China.
- Conditions
- Dermatitis, Atopic
- Being tested
- No intervention
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy | Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
Physician-reported outcome tool, SCORAD index, will be used to evaluate the objective severity of clinical signs of Atopic Dermatitis .
Measured: At Month 12
Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
Measured: At Month 12
Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
Measured: At Month 12
Patient-reported disease control after Atopic Dermatitis therapies in real life
Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
Measured: At Month 12
Patient-reported quality of life after Atopic Dermatitis therapies in real life
Dermatology Life Quality Index (DLQI) will be used to assess quality of life, and DLQI for children (cDLQL) will be used for adolescence patients.
Measured: At Month 12
The Atopic Dermatitis related economic burden
Economic burden of Atopic Dermatitis will be evaluated using the cost of hospitalizations and outpatient visits associated with Atopic Dermatitis during the past one year.
Measured: At Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start28 Jul 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang jianzhong, Peking University People's Hospital
- Investigators
- Jianzhong Zhang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023668
- Sponsor's protocol ID
- SGZ-2020-12888
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu P, Lin B, Shen Y, Lu Y, Li J, Lv D, Yao X, Man X, Fang H, Jiang G, Yu N, Liu D, Zhan S, Zhang J. The ChinaSTAD Chinese Registry in Patients with Moderate-To-Severe Atopic Dermatitis Not Controlled by Topical Therapy: Baseline Characteristics, Disease Burden and Treatment. Dermatol Ther (Heidelb). 2025 Nov;15(11):3377-3389. doi: 10.1007/s13555-025-01540-w. Epub 2025 Sep 19.
PubMed 40971027
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy
- ClinicalTrials.gov ID
- NCT05023668
- Acronym / sponsor ID
- SGZ-2020-12888
- Conditions
- Dermatitis, Atopic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Aug 2021 (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 regestry study is aimed to characterize the medical care and drug treatment under real-life conditions among Chinese patients with moderate to severe Atopic Dermatitis who are not well controlled by topical therapies.
Detailed description
Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. A survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland China has shown that the incidence of AD in outpatients (7.8%) has been raised in recent years.
Among topical therapy of AD, corticosteroids are first line therapy. In patients with extensive and severe dermatitis, topical therapy may be insufficient. Such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. There is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. There is not clear recommendation grade for these therapy in Chinese AD guideline and no published data to demonstrate current treatment situation in real clinical practise.
The goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. This study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among AD patients in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy | – | Other: No interventionChinese moderate to severe atopic dermatitis patients not controlled by topical therapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese moderate-to-severe atopic dermatitis patients who are not controlled by topical therapy.
Key inclusion criteria (5 listed)
- Age≥12;
- AD according to Williams diagnosis criteria (see Appendix 1);
- Moderate to severe AD that inadequately controlled by topical therapy
- Moderate-to-severe: SCORAD score≥25; or
- Inadequately controlled by topic therapies: Determined by physicians.
Key exclusion criteria (1 listed)
- No.
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 |
|---|---|---|
| No interventionNo intervention | Other | Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy |
Primary outcome
Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
Time frame: At Month 12
Physician-reported outcome tool, SCORAD index, will be used to evaluate the objective severity of clinical signs of Atopic Dermatitis .
Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
Time frame: At Month 12
Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
Time frame: At Month 12
Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
Patient-reported disease control after Atopic Dermatitis therapies in real life
Time frame: At Month 12
Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
Patient-reported quality of life after Atopic Dermatitis therapies in real life
Time frame: At Month 12
Dermatology Life Quality Index (DLQI) will be used to assess quality of life, and DLQI for children (cDLQL) will be used for adolescence patients.
The Atopic Dermatitis related economic burden
Time frame: At Month 12
Economic burden of Atopic Dermatitis will be evaluated using the cost of hospitalizations and outpatient visits associated with Atopic Dermatitis during the past one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 40971027Liu P, Lin B, Shen Y, Lu Y, Li J, Lv D, Yao X, Man X, Fang H, Jiang G, Yu N, Liu D, Zhan S, Zhang J. The ChinaSTAD Chinese Registry in Patients with Moderate-To-Severe Atopic Dermatitis Not Controlled by Topical Therapy: Baseline Characteristics, Disease Burden and Treatment. Dermatol Ther (Heidelb). 2025 Nov;15(11):3377-3389. doi: 10.1007/s13555-025-01540-w. Epub 2025 Sep 19.
- Individual participant dataSharing planned: No
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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.
Jianzhong Zhang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by Peking University People's Hospital at 1 site in China.
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 5 inclusion and 1 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 26 Aug 2021. 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 China. 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 Jianzhong Zhang (010-88325472, rmzjz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician evaluated effectiveness of Atopic Dermatitis therapies in real life (time frame: At Month 12). The study lists 6 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 NCT05023668, which also lists 1 linked publication.
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 26 Aug 2021.