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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150059
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 15, 2008
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Brief Summary:

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 or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus Cream 1% Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Intervention Details:
  • Drug: Pimecrolimus Cream 1%
    Other Name: Elidel

Primary Outcome Measures :
  1. Investigator Global Assessment (IGA) score for the whole body and for the face only.
  2. Pruritus (itch) severity assessments, and patient's self-assessment of disease control at the start of study and on day 7, 30 and 90 after treatment initiation.
  3. Safety assessed by adverse events.

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150059

This study is not being conducted in the United States
Investigative Site, Philippines
Sponsors and Collaborators
Study Chair: Novartis Healthcare Philippines Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Identifier: NCT00150059     History of Changes
Other Study ID Numbers: CASM981CPH01
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: February 2008

Keywords provided by Novartis:
atopic dermatitis, eczema, mild to moderate, children, IGA

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action