A Clinical Study in Children and Adolescents With Mild to... | NCT00568412

Studies
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis

NCT00568412

Sponsor

Bayer

Status

Completed

Last Update Posted

Feb 18, 2015Estimated

Enrollment

80Actual

Phase

Phase 4

Conditions

Mild to Moderate Atopic Dermatitis

Interventions

Zarzenda
Elidel

Countries

Germany

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

Feb 2015

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

Dec 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Dec 3, 2007

First Submission Date that Met QC Criteria

Dec 5, 2007

First Posted Date

Dec 6, 2007Estimated

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

Feb 15, 2015

Last Update Posted Date

Feb 18, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Zarzenda applied topically twice daily for three weeks	Device: Zarzenda
2	Active Comparator	Elidel 1% cream, applied topically twice daily for three weeks	Drug: Elidel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zarzenda	Device	Topical cream, applied twice daily for three weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigator's Global Assessment		End of study compared to baseline

Secondary Outcomes

Measure	Description	Time Frame
EASI		End of study compared to baseline
Affected body surface area		End of study compared to baseline
Patient's assessment of itch, quality of sleep, and global assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male and female children and adolescents (aged 2 - 17)
mild to moderate atopic dermatitis
patients in whom a treatment with topical corticosteroids in not recommended or possible
wash out periods to be observed

Exclusion Criteria:

known allergy to one of the two treatments
known immunodeficiency
known hepatic or renal insufficiency
acute skin infections

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum		Bonn		53105	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C117268	pimecrolimus

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided