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Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age with Mild or Moderate 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 ≥ 3 Months of Age with Mild or Moderate Atopic Dermatitis

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

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00150059

Purpose

To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)

This study is not enrolling patients in the United States.

Condition Intervention Phase
Atopic Dermatitis
 Drug: Pimecrolimus Cream 1%
Phase IV

MedlinePlus related topics:  Allergy;   Dermatitis;   Genetic Disorders;   Skin Conditions

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Study Details: 

Study start: December 2004

Eligibility

Ages Eligible for Study:  3 Months and above,  Genders Eligible for Study:  Both
Criteria
The patient population must consist of male or female outpatients, age ≥3 months old with mild to moderate atopic dermatitis (IGA ≥ 1). Exclusion criteria are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00150059

Novartis Pharma AG      + 41 61 324 1111 

Philippines
      This study is not being conducted in the United States, NA,  Philippines; Recruiting
Novartis Pharma AG  41 61 324 1111 

Study chairs or principal investigators

Novartis Healthcare Philippines,  Study Chair,  Novartis   

More Information

Study ID Numbers:  CASM981CPH01
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00150059
Health Authority: Philippines: Bureau of Food and Drugs
ClinicalTrials.gov processed this record on 2005-09-13


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