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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-18

Study Completion Date

2022-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pimecrolimus Cream 1% - Elidel®

Elidel® as prescribed within routine clinical practice

Pimecrolimus 1% Top Cream

Intervention Type DRUG

Elidel® as prescribed within routine clinical practice

Interventions

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Pimecrolimus 1% Top Cream

Elidel® as prescribed within routine clinical practice

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No