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China Atopic Dermatitis Registry Study

China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05023668
Enrollment
10000
Registered
2021-08-26
Start date
2021-07-28
Completion date
2024-10-31
Last updated
2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

Brief 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.

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Physician evaluated effectiveness of Atopic Dermatitis therapies in real lifeAt Month 12Physician-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 lifeAt Month 12Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
Patient-reported severity of pruritus after Atopic Dermatitis therapies in real lifeAt Month 12Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
Patient-reported disease control after Atopic Dermatitis therapies in real lifeAt Month 12Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
Patient-reported quality of life after Atopic Dermatitis therapies in real lifeAt Month 12Dermatology 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 burdenAt Month 12Economic burden of Atopic Dermatitis will be evaluated using the cost of hospitalizations and outpatient visits associated with Atopic Dermatitis during the past one year.

Countries

China

Contacts

Primary ContactJianzhong Zhang
rmzjz@126.com010-88325472
Backup ContactPing Liu
llppliuping@126.com010-88325472

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026