NCT00121381

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Pimecrolimus plus topical corticosteroid (TCS)	Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
DRUG	Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)	twice daily administration

Timeline

• Start date: 2005-05-01
• Completion: 2007-01-01
• First posted: 2005-07-21
• Last updated: 2008-01-15

Locations

13 sites across 1 country: United States