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Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130364
First Posted: August 15, 2005
Last Update Posted: January 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
August 12, 2005
August 15, 2005
January 15, 2008
August 2005
Not Provided
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Not Provided
Complete list of historical versions of study NCT00130364 on ClinicalTrials.gov Archive Site
  • Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
  • The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
  • The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
  • Time to clearance of facial IGA (score of 0 or 1)
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis
Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

This study is not being conducted in the United States of America (USA).

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: Pimecrolimus
    Pimecrolimus 1 % cream
    Other Name: Elidel
  • Drug: Placebo
    Pimecrolimus vehicle cream (placebo)
  • Experimental: 1
    Pimecrolimus
    Intervention: Drug: Pimecrolimus
  • Placebo Comparator: 2
    Pimecrolimus vehicle cream
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2006
Not Provided

Inclusion Criteria:

  • Mild to moderate facial atopic dermatitis
  • Patients intolerant of, or dependent on, topical corticosteroids

Exclusion Criteria:

  • Concurrent skin diseases (infections)
  • Immunocompromised
  • Recently received phototherapy or systemic therapy
Sexes Eligible for Study: All
2 Years to 11 Years   (Child)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00130364
CASM981C2440
Not Provided
Not Provided
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP