Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis
1 other identifier
observational
130
1 country
10
Brief Summary
The primary objective of the present multicentre, prospective, non-interventional study (NIS) is gathering knowledge on the actual use and effectiveness of Elidel® in Chinese patients with mild to moderate AD affecting sensitive skin areas in routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
10 active sites
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
March 18, 2021
CompletedFirst Submitted
Initial submission to the registry
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedMay 24, 2023
May 1, 2023
1.6 years
July 15, 2021
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
SCORAD
The primary outcome measure is the "change from baseline in SCORAD INDEX". The achievable score in SCORAD INDEX range from 0 to 103. The classification of severity would be as follows mild (\<25), moderate (25-50) and severe (≥50).
The study ends after the Maintenance Period of at least 3 months allowing certain flexibility to respond to the routine practice. End of Study will be approx. 6 months after the inclusion depending length of the Elidel® Treatment Period.
Study Arms (1)
Pimecrolimus Cream 1% - Elidel®
Elidel® as prescribed within routine clinical practice
Interventions
Elidel® as prescribed within routine clinical practice
Eligibility Criteria
Chinese patients at least 2 years old with mild to moderate atopic dermatitis affecting sensitive skin areas
You may qualify if:
- Patients of Chinese ethnicity
- Patients at least 2 years old
- Signed informed consent from patient and if applicable from parent(s) or legal guardian(s) in compliance with local requirements
- Patients with mild to moderate AD and depending on the age:
- Patients 2-12 years must have:
- \- SCORAD Index \< 50
- Patients 13 years and older must have:
- Affecting sensitive skin areas (e.g. face, intertriginous sites, anogenital area)
- SCORAD Index \< 50 and IGA in sensitive skin areas ≤ 3
You may not qualify if:
- Patients for whom Elidel® is not recommended accordingly to the Package Insert
- Patients with severe atopic dermatitis (SCORAD Index ≥ 50 or IGA in sensitive skin \> 3)
- Pregnant and/or breastfeeding women
- Patients or parent(s) / legal guardian (as applicable) that are not able to fulfil study requirements according to physician's opinion
- Patients or parent(s) / legal guardian (as applicable) that refuse to participate to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Beijing children's Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Children's Hospital Capital Institute of Pediatrics
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Children's hospital of Chongqing medical university
Chongqing, China
The third affiliated hospital, sun yat-sen university
Guangzhou, China
The first Hospital of China Medical University
Shenyang, China
Peking University Shenzhen Hospital
Shenzhen, China
Tongji Medical College Huazhong University of Science & Technology
Wuhan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2021
First Posted
July 26, 2021
Study Start
March 18, 2021
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
May 24, 2023
Record last verified: 2023-05