Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00121381
First received: July 14, 2005
Last updated: January 10, 2008
Last verified: January 2008

July 14, 2005
January 10, 2008
May 2005
Not Provided
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
Not Provided
Complete list of historical versions of study NCT00121381 on ClinicalTrials.gov Archive Site
  • Incidence of all other adverse events
  • Time to relapse of atopic dermatitis
  • Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
  • Efficacy measured by IGA (treatment success and improvement)
  • Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent
Not Provided
Not Provided
Not Provided
 
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dermatitis, Atopic
  • Drug: Pimecrolimus plus topical corticosteroid (TCS)
    Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
    Other Name: Elidel
  • Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
    twice daily administration
  • Experimental: 1
    Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
    Intervention: Drug: Pimecrolimus plus topical corticosteroid (TCS)
  • Placebo Comparator: 2
    Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
    Intervention: Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
January 2007
Not Provided

Inclusion Criteria:

  • Severe atopic dermatitis
  • 5% of total body surface area (TBSA) affected

Exclusion Criteria:

  • Concurrent skin diseases (infections)
  • Immunocompromised
  • Recently received phototherapy or systemic therapy
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00121381
CASM981C2439
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