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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150059
First Posted: September 8, 2005
Last Update Posted: February 15, 2008
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.
Information provided by:
Novartis
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00150059


Locations
Philippines
This study is not being conducted in the United States
Investigative Site, Philippines
Sponsors and Collaborators
Novartis
Investigators
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
First Submitted: September 7, 2005
First Posted: September 8, 2005
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
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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