Clinical trial NCT05023668: China Atopic Dermatitis Registry Study
Official title: China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatitis, Atopic
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese moderate-to-severe atopic dermatitis patients who are not controlled by topical therapy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
timeFrame: At Month 12
measure: Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
timeFrame: At Month 12
measure: Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
timeFrame: At Month 12
measure: Patient-reported disease control after Atopic Dermatitis therapies in real life
timeFrame: At Month 12
measure: Patient-reported quality of life after Atopic Dermatitis therapies in real life
timeFrame: At Month 12
measure: The Atopic Dermatitis related economic burden
timeFrame: At Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jianzhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: