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CompletedNCT04976868Updated May 24, 2023

Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis

An observational study in Atopic Dermatitis, sponsored by Mylan Inc.. Completed at 10 sites in China. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Mylan Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
2 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis
03

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chinese patients at least 2 years old with mild to moderate atopic dermatitis affecting sensitive skin areas

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, inhibitors, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion;
  • Receiving any topical AD-effective drugs within the last 2 weeks before inclusion;
  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (actual)
Patient registry
No

Groups and cohorts

  • Pimecrolimus Cream 1% - Elidel®

    Elidel® as prescribed within routine clinical practice

    Drug: Pimecrolimus 1% Top Cream

Interventions

  • DrugPimecrolimus 1% Top Cream

    Elidel® as prescribed within routine clinical practice

05

What researchers measure

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).

    Time frame: 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.

06

Study locations

10 sites
  • 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
07

Registry details

Key details

Study ID
NCT04976868
Lead sponsor
Mylan Inc.
Collaborators
Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.
Responsible party
Sponsor
First posted
Jul 26, 2021
Start date
Mar 18, 2021
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022
Last update
May 24, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Dermatitis, Atopic→

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Mylan Inc.

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