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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Pimecrolimus 1% Top Cream

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Beijing Hospital
  • Beijing, China
    • Beijing Children's Hospital, Capital Medical University
  • Beijing, China
    • Children's Hospital Capital Institute of Pediatrics
  • Chongqing, China
    • Children's Hospital of Chongqing Medical University
  • Guangzhou, China
    • The Third Affiliated Hospital, Sun Yat-sen University
  • Shenyang, China
    • The First Hospital of China Medical University
  • Shenzhen, China
    • Peking University Shenzhen Hospital
  • Wuhan, China
    • Tongji Medical College Huazhong University of Science & Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pimecrolimus Cream 1% - Elidel®; Elidel® as prescribed within routine clinical practice	Drug: Pimecrolimus 1% Top Cream; Elidel® as prescribed within routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Calcineurin Inhibitors; Pimecrolimus
• Other Study ID Numbers: 3328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No