China Atopic Dermatitis Registry Study

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023668
• Other study ID #: SGZ-2020-12888
• Status: Recruiting
• Start date: July 28, 2021
• Est. completion date: October 2024

Study information

• Verified date: August 2021
• Source: Peking University People's Hospital
• Contact: Jianzhong Zhang
• Phone: 010-88325472
• Email: rmzjz[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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