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

NCT04976868 — Completed, 130 participants, Mylan Inc.

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RegistryNCT04976868
StatusCompleted
Study typeObservational
Enrollment130 (Actual)
SponsorMylan Inc. (Industry); collaborators: Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.
ConditionsAtopic Dermatitis
InterventionsPimecrolimus 1% Top Cream (Drug)
Datesstart 2021-03-18, primary completion 2022-10-31, completion 2022-10-31, first posted 2021-07-26, last updated 2023-05-24
Locations10 sites in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Pimecrolimus Cream 1% - Elidel®Drug: Pimecrolimus 1% Top CreamElidel® as prescribed within routine clinical practice
  • Pimecrolimus 1% Top Cream (Drug): Elidel® as prescribed within routine clinical practice

+Outcome measures

Primary outcomes

  • 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).

+Eligibility

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

+Locations (10)

FacilityCityCountryStatus
Beijing children's Hospital, Capital Medical UniversityBeijingChina
Beijing HospitalBeijingChina
Children's Hospital Capital Institute of PediatricsBeijingChina
Peking University First HospitalBeijingChina
Peking University Third HospitalBeijingChina
Children's hospital of Chongqing medical universityChongqingChina
The third affiliated hospital, sun yat-sen universityGuangzhouChina
The first Hospital of China Medical UniversityShenyangChina
Peking University Shenzhen HospitalShenzhenChina
Tongji Medical College Huazhong University of Science & TechnologyWuhanChina

My Notes