NCT05023668

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

3.2 years

First QC Date

August 16, 2021

Last Update Submit

August 20, 2021

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

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

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

Other: No intervention

Interventions

No interventionOTHER

No intervention

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

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • No.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

  • Liu P, Lin B, Shen Y, Lu Y, Li J, Lv D, Yao X, Man X, Fang H, Jiang G, Yu N, Liu D, Zhan S, Zhang J. The ChinaSTAD Chinese Registry in Patients with Moderate-To-Severe Atopic Dermatitis Not Controlled by Topical Therapy: Baseline Characteristics, Disease Burden and Treatment. Dermatol Ther (Heidelb). 2025 Nov;15(11):3377-3389. doi: 10.1007/s13555-025-01540-w. Epub 2025 Sep 19.

    PMID: 40971027DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jianzhong Zhang

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianzhong Zhang

CONTACT

010-88325472rmzjz@126.com

Ping Liu

CONTACT

010-88325472llppliuping@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Department of Dermatology

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 26, 2021

Study Start

July 28, 2021

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)