Steroid-Sparing Effect With Pimecrolimus in Pediatric Pat... | NCT00351052

Studies
Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis

NCT00351052

Sponsor

Novartis

Status

Completed

Last Update Posted

Jan 17, 2008Estimated

Enrollment

184Actual

Phase

Phase 3

Conditions

Atopic Dermatitis

Interventions

Pimecrolimus
Placebo

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

Jan 2008

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 2001

Primary Completion Date

Not provided

Completion Date

Sep 2004Actual

First Submitted Date

Jul 10, 2006

First Submission Date that Met QC Criteria

Jul 10, 2006

First Posted Date

Jul 12, 2006Estimated

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

Jan 15, 2008

Last Update Posted Date

Jan 17, 2008Estimated

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

184Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Pimecrolimus	Drug: Pimecrolimus
2	Placebo Comparator	Vehicle	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pimecrolimus	Drug	Pimecroliums cream 1 % bid.	1	Elidel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corticoid-sparing effect of pimecrolimus cream 1%

Secondary Outcomes

Measure	Description	Time Frame
atopic dermatitis control
safety of pimecrolimus cream 1%
quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase

Exclusion Criteria:

Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis AG	Novartis	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic
D004485	Eczema

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