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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 7, 2005
Last updated: February 14, 2008
Last verified: February 2008

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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Investigator Global Assessment (IGA) score for the whole body and for the face only.
  • 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.
  • Safety assessed by adverse events.

Study Start Date: December 2004
Study Completion Date: December 2005
Intervention Details:
    Drug: Pimecrolimus Cream 1%
    Other Name: Elidel

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00150059

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

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00150059     History of Changes
Other Study ID Numbers: CASM981CPH01 
Study First Received: September 7, 2005
Last Updated: February 14, 2008
Health Authority: Philippines: Bureau of Food and Drugs

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

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

ClinicalTrials.gov processed this record on May 26, 2016