| Registry | NCT04976868 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 130 (Actual) |
| Sponsor | Mylan Inc. (Industry); collaborators: Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd. |
| Conditions | Atopic Dermatitis |
| Interventions | Pimecrolimus 1% Top Cream (Drug) |
| Dates | start 2021-03-18, primary completion 2022-10-31, completion 2022-10-31, first posted 2021-07-26, last updated 2023-05-24 |
| Locations | 10 sites in China |
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All trials for Atopic Dermatitis All trials of Pimecrolimus 1% Top Cream
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pimecrolimus Cream 1% - Elidel® | Drug: Pimecrolimus 1% Top Cream | Elidel® as prescribed within routine clinical practice |
Sex: All, ages: 2 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing children's Hospital, Capital Medical University | Beijing | China | |
| Beijing Hospital | Beijing | China | |
| Children's Hospital Capital Institute of Pediatrics | Beijing | China | |
| Peking University First Hospital | Beijing | China | |
| Peking University Third Hospital | Beijing | China | |
| Children's hospital of Chongqing medical university | Chongqing | China | |
| The third affiliated hospital, sun yat-sen university | Guangzhou | China | |
| The first Hospital of China Medical University | Shenyang | China | |
| Peking University Shenzhen Hospital | Shenzhen | China | |
| Tongji Medical College Huazhong University of Science & Technology | Wuhan | China |