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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Pimecrolimus
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, pimecrolimus

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • This study is not being conducted in the United States

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Pimecrolimus

Matching vehicle cream (placebo)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Percentage of patients achieving a score of 0 or 1 for the pruritus score (absent or mild)
Effects on skin atrophy and telangiectasia (spider veins) existing at baseline

Full Information

First Posted
July 13, 2005
Last Updated
January 10, 2008
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00121316
Brief Title
Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) Patients
Official Title
Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) of Patients Intolerant to, or Dependant on, Topical Corticosteroids
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, pimecrolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Pimecrolimus
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching vehicle cream (placebo)
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus Cream 1 %
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle cream (placebo cream)
Primary Outcome Measure Information:
Title
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Secondary Outcome Measure Information:
Title
Percentage of responders in overall Eczema Area and Severity Index (EASI) score
Title
Percentage of responders in the head and neck EASI score
Title
Percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
Title
Percentage of patients achieving a score of 0 or 1 for the pruritus score (absent or mild)
Title
Effects on skin atrophy and telangiectasia (spider veins) existing at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
This study is not being conducted in the United States
City
Novartis Pharma AG
Country
Switzerland

12. IPD Sharing Statement

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

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