Efficacy and Safety of Pimecrolimus Cream 1% in Patients... | NCT00130364

Studies
Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

NCT00130364

Sponsor

Novartis

Status

Completed

Last Update Posted

Jan 15, 2008Estimated

Enrollment

200

Phase

Phase 4

Conditions

Atopic Dermatitis

Interventions

Pimecrolimus
Placebo

Countries

United States

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

Aug 2005

Primary Completion Date

Not provided

Completion Date

Aug 2006Actual

First Submitted Date

Aug 12, 2005

First Submission Date that Met QC Criteria

Aug 12, 2005

First Posted Date

Aug 15, 2005Estimated

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 10, 2008

Last Update Posted Date

Jan 15, 2008Estimated

Description Module

Brief Summary

This study is not being conducted in the United States of America (USA).

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

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

200

Arms/Interventions Module

Arm Groups

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

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate facial atopic dermatitis
Patients intolerant of, or dependent on, topical corticosteroids

Exclusion Criteria:

Concurrent skin diseases (infections)
Immunocompromised
Recently received phototherapy or systemic therapy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
This study is not being conducted in the United States		Novartis Pharmaceuticals	New Jersey		United States

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic
D019066	Facies

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