China Atopic Dermatitis Registry Study

Study Overview
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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.

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

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy<br>Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 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 | 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. | 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. | 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. | 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. | At Month 12 |