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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014