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

Tracking Information

First Received Date ^ICMJE

July 14, 2005

Last Updated Date

January 10, 2008

Start Date ^ICMJE

May 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00121381 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Dermatitis, Atopic

Intervention ^ICMJE

Drug: Pimecrolimus plus topical corticosteroid (TCS)
Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)

Study Arms / Comparison Groups

Experimental: Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
Placebo Comparator: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

January 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00121381

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CASM981C2439

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP