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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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00150059
First received: September 7, 2005
Last updated: February 14, 2008
Last verified: February 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   3 Months and older
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Dermatitis, Atopic
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013