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

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Jianzhong Zhang; Phone Number: 010-88325472; Email: rmzjz@126.com
• Study Contact Backup: Name: Ping Liu; Phone Number: 010-88325472; Email: llppliuping@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Ping Liu; Phone Number: 010 88325472; Email: llppliuping@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese moderate-to-severe atopic dermatitis patients who are not controlled by topical therapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy	Other: No intervention; No intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Jianzhong Zhang, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: SGZ-2020-12888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No