China Atopic Dermatitis Registry Study

Overview

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.

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2024

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

  • Other: No intervention
    • No intervention

Arms, Groups and Cohorts

  • Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy
    • Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy

Clinical Trial Outcome Measures

Primary Measures

  • Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
    • Time Frame: At Month 12
    • Physician-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 life
    • Time Frame: At Month 12
    • Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
  • Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
    • Time Frame: At Month 12
    • Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
  • Patient-reported disease control after Atopic Dermatitis therapies in real life
    • Time Frame: At Month 12
    • Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
  • Patient-reported quality of life after Atopic Dermatitis therapies in real life
    • Time Frame: At Month 12
    • Dermatology 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 burden
    • Time Frame: At Month 12
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Peking University People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhang jianzhong, Professor and Chairman, Department of Dermatology – Peking University People’s Hospital
  • Overall Official(s)
    • Jianzhong Zhang, Principal Investigator, Peking University People’s Hospital
  • Overall Contact(s)
    • Jianzhong Zhang, 010-88325472, rmzjz@126.com

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