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

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121381
• Other study ID #: CASM981C2439
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2005
• Last updated: January 10, 2008
• Start date: May 2005
• Est. completion date: January 2007

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus plus topical corticosteroid (TCS)
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
• Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
twice daily administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
Secondary	Incidence of all other adverse events
Secondary	Time to relapse of atopic dermatitis
Secondary	Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
Secondary	Efficacy measured by IGA (treatment success and improvement)
Secondary	Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent