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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976868
• Other study ID #: 3328
• Status: Completed
• Start date: March 18, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2023
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus 1% Top Cream
Elidel® as prescribed within routine clinical practice

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.