MedPath

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

Registration Number
NCT00121381
Lead Sponsor
Novartis
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
400
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Pimecrolimus plus topical corticosteroid (TCS)Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
2Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Primary Outcome Measures
NameTimeMethod
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (13)

Children's Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Calcagno Research and Development

🇺🇸

Gresham, Oregon, United States

Pediatric Care Medical Group, Inc.

🇺🇸

Huntington Beach, California, United States

Children's Hospital -San Diego

🇺🇸

San Diego, California, United States

Medical College of Georgia - Clinical Investigative Services

🇺🇸

Augusta, Georgia, United States

Wake Forest University School of Medicine Dept. of Dermatology

🇺🇸

Winston-Salem, North Carolina, United States

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

A.S.T.H.M.A., Inc

🇺🇸

Seattle, Washington, United States

Dermatology Associates and Research

🇺🇸

Coral Gables, Florida, United States

Dartmouth Hitchcock Medical Center Section of Dermatology

🇺🇸

Lebanon, New Hampshire, United States

520 Trinity Creek Cove

🇺🇸

Cordova, Tennessee, United States

National Jewish Medical and Research Center

🇺🇸

Denver, Colorado, United States

Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

© Copyright 2025. All Rights Reserved by MedPath