Safety and Efficacy of Pimecrolimus Cream 1% in Mild to M... | NCT00121316

Studies
Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) Patients

NCT00121316

Sponsor

Novartis

Status

Completed

Last Update Posted

Jan 15, 2008Estimated

Enrollment

200

Phase

Phase 4

Conditions

Atopic Dermatitis

Interventions

Pimecrolimus
Placebo

Countries

Switzerland

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

Oct 2004

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Jul 13, 2005

First Submission Date that Met QC Criteria

Jul 19, 2005

First Posted Date

Jul 21, 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.

Patients who are intolerant of topical corticosteroids (TCS) have either experienced an adverse event resulting from the use of TCS, or require unacceptable levels of exposure to TCS in order to control their AD. This is of particular concern for patients with recurrent flares on delicate skin areas such as the head and neck.

The purpose of this study is to investigate whether pimecrolimus cream 1%, a non-steroidal anti-inflammatory drug, is efficacious in treating mild to moderate head and neck AD in patients who are 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

Label	Type	Description	Intervention Names
1	Experimental	Pimecrolimus	Drug: Pimecrolimus
2	Placebo Comparator	Matching vehicle cream (placebo)	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Pimecrolimus	Drug	Pimecrolimus Cream 1 %	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 responders in overall Eczema Area and Severity Index (EASI) score
Percentage of responders in the head and neck EASI score
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:

12 years of age or older
Mild to moderate facial AD at screening (facial IGA 2 - 3)
Patients intolerant of, or dependent on, topical corticosteroids
Diagnosis of atopic dermatitis by the Hanifin and Rajka criteria
For female patients, a negative pregnancy test. Women who are pregnant or who are breast-feeding may not be included in the study. Women of child-bearing potential must follow a medically recognized form of contraception.

Exclusion Criteria:

At baseline and throughout the study, patients:

Who have AD on greater than 30% of total body surface area in addition to facial eczema
Who have concurrent skin disease (e.g. acne) in the study area or active skin infections (active bacterial, viral or fungal infections or infestations, herpes simplex, herpes zoster, chicken pox), or other conditions that may interfere with the evaluation (e.g. generalized erythroderma, Netherton's syndrome)
Who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease (with the exception of treated basal-cell carcinoma)
Who have previously reported poor, no clinical response, or hypersensitivity to topical pimecrolimus cream (Elidel)
Who have received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g.immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 2
Who have received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study
Who are unlikely to comply with therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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