Observational Study to Evaluate the Actual Use of Elidel®... | NCT04976868

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

NCT04976868

Sponsor

Mylan Inc.

Status

Completed

Last Update Posted

May 24, 2023Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

Pimecrolimus 1% Top Cream

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2021Actual

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Oct 31, 2022Actual

First Submitted Date

Jul 15, 2021

First Submission Date that Met QC Criteria

Jul 15, 2021

First Posted Date

Jul 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2023

Last Update Posted Date

May 24, 2023Actual

Name	Class
Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pimecrolimus Cream 1% - Elidel®		Elidel® as prescribed within routine clinical practice	Drug: Pimecrolimus 1% Top Cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pimecrolimus 1% Top Cream	Drug	Elidel® as prescribed within routine clinical practice	Pimecrolimus Cream 1% - Elidel®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SCORAD	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).	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Chinese patients at least 2 years old with mild to moderate atopic dermatitis affecting sensitive skin areas

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Beijing children's Hospital, Capital Medical University		Beijing			China
Beijing Hospital

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis