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Completed

NCT Number: NCT04976868

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pimecrolimus 1% Top Cream

Drug

Elidel® as prescribed within routine clinical practice

Primary outcomes

  1. SCORAD

    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.

    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).

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2021
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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