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

Completed · Phase 4 · Has a placebo group

Conditions studied: Dermatitis, Atopic

In brief

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.

Key facts

Study ID

NCT00121381

Run by

Novartis

People needed

400

Starts

2005-05-01

Expected to finish

2007-01-01

Last updated by the study team

2008-01-15

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Concurrent skin diseases (infections)
• Immunocompromised
• Recently received phototherapy or systemic therapy

Where it is running

• Pediatric Care Medical Group, Inc. — Huntington Beach, California, United States
• Children's Hospital -San Diego — San Diego, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Dermatology Associates and Research — Coral Gables, Florida, United States
• Medical College of Georgia - Clinical Investigative Services — Augusta, Georgia, United States
• Dartmouth Hitchcock Medical Center Section of Dermatology — Lebanon, New Hampshire, United States
• Wake Forest University School of Medicine Dept. of Dermatology — Winston-Salem, North Carolina, United States
• Calcagno Research and Development — Gresham, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• 520 Trinity Creek Cove — Cordova, Tennessee, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• A.S.T.H.M.A., Inc — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.