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

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Pimecrolimus 1% Top Cream

• Registration Number: NCT04976868
• Lead Sponsor: Mylan Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-18
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pimecrolimus Cream 1% - Elidel®	Pimecrolimus 1% Top Cream	Elidel® as prescribed within routine clinical practice

Primary Outcome Measures

Name	Time	Method
SCORAD	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.	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).

Trial Locations

Locations (10)

The first Hospital of China Medical University; 🇨🇳 Shenyang, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, China

Children's Hospital Capital Institute of Pediatrics; 🇨🇳 Beijing, China

Children's hospital of Chongqing medical university; 🇨🇳 Chongqing, China

Beijing children's Hospital, Capital Medical University; 🇨🇳 Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China

Beijing Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

The third affiliated hospital, sun yat-sen university; 🇨🇳 Guangzhou, China

Tongji Medical College Huazhong University of Science & Technology; 🇨🇳 Wuhan, China