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

NCT ID: NCT00130364

Last Updated: 2008-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-08-31

Brief Summary

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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

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Pimecrolimus

Group Type EXPERIMENTAL

Pimecrolimus

Intervention Type DRUG

Pimecrolimus 1 % cream

2

Pimecrolimus vehicle cream

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pimecrolimus vehicle cream (placebo)

Interventions

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Pimecrolimus

Pimecrolimus 1 % cream

Intervention Type DRUG

Placebo

Pimecrolimus vehicle cream (placebo)

Intervention Type DRUG

Other Intervention Names

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Elidel

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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This study is not being conducted in the United States

Novartis Pharmaceuticals, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CASM981C2440

Identifier Type: -

Identifier Source: org_study_id

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