Atopic Dermatitis
Conditions
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.
Interventions
DRUGPimecrolimus 1% Top Cream
Elidel® as prescribed within routine clinical practice
Sponsors
Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.
Mylan Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Outcome results
None listed