Clinical trial NCT04976868: Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis
Official title: Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.
First posted: 2021-07-26
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients at least 2 years old with mild to moderate atopic dermatitis affecting sensitive skin areas

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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: SCORAD
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing children's Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Children's Hospital Capital Institute of Pediatrics
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chongqing
country: China
facility: Children's hospital of Chongqing medical university
city: Guangzhou
country: China
facility: The third affiliated hospital, sun yat-sen university
city: Shenyang
country: China
facility: The first Hospital of China Medical University
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Wuhan
country: China
facility: Tongji Medical College Huazhong University of Science & Technology
Study officials:
References: