Clinical trial NCT00121381: Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Official title: Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Atopic dermatitis
T-cell
pimecrolimus
children
topical corticosteroids
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-07-21
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
Secondary outcomes:
measure: Incidence of all other adverse events
measure: Time to relapse of atopic dermatitis
measure: Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
measure: Efficacy measured by IGA (treatment success and improvement)
measure: Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Children's Hospital -San Diego
state: California
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Coral Gables
country: United States
facility: Dermatology Associates and Research
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia - Clinical Investigative Services
state: Georgia
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center Section of Dermatology
state: New Hampshire
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine Dept. of Dermatology
state: North Carolina
city: Gresham
country: United States
facility: Calcagno Research and Development
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Cordova
country: United States
facility: 520 Trinity Creek Cove
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: A.S.T.H.M.A., Inc
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: