China Atopic Dermatitis Registry Study

NCT ID: NCT05023668

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-28

Study Completion Date

2024-10-31

Brief Summary

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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

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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

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Dermatitis, Atopic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy

Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* No.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang jianzhong

Professor and Chairman, Department of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianzhong Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianzhong Zhang

Role: CONTACT

010-88325472

Ping Liu

Role: CONTACT

010-88325472

Facility Contacts

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Ping Liu

Role: primary

010 88325472

References

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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 Sep 19. doi: 10.1007/s13555-025-01540-w. Online ahead of print.

Reference Type DERIVED
PMID: 40971027 (View on PubMed)

Other Identifiers

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SGZ-2020-12888

Identifier Type: -

Identifier Source: org_study_id

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