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


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Dermatitis

Types of dermatitis; Contact Dermatitis; Dermatitis-Atopic Eczema; Dermatitis/Eczema; Rash; Skin Disorders, Dermatitis; Skin Rash; Slide Show: Types of Dermatitis


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

This study is currently recruiting patients.
Verified by Novartis August 2005

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00130364

Purpose

This study is not being conducted in the USA

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the 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. .

Condition Intervention Phase
Facial atopic dermatitis
 Drug: Pimecrolimus Cream 1%
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Study start: August 2005

Eligibility

Ages Eligible for Study:  2 Years   -   11 Years,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00130364

Novartis Pharmaceuticals      862 778 8300 

New Jersey
      This study is not being conducted in the United States, Novartis Pharmaceuticals,  New Jersey,  United States; Recruiting
Novartis Pharmaceuticals  862-778-8300 

Study chairs or principal investigators

Novartis Pharmaceuticals,  Study Chair,  Novartis   

More Information

Study ID Numbers:  ASM981C2440
Last Updated:  August 12, 2005
Record first received:  August 12, 2005
ClinicalTrials.gov Identifier:  NCT00130364
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices; South Korea: Korea Food and Drug Administration (KFDA); Slovakia: State Institute for Drug Control
ClinicalTrials.gov processed this record on 2005-08-23


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July 26, 2008



Page Updated: May 11, 2006
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