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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 14, 2005

Last Updated Date

January 10, 2008

Start Date ^†

May 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

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

Current Secondary Outcome Measures ^†

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 ^†

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 ^†

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

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 ^†

Interventional

Study Design ^†

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

Condition ^†

Dermatitis, Atopic

Intervention ^†

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 ^†

Completed

Enrollment ^†

400

Completion Date

January 2007

Primary Completion Date

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

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00121381

Responsible Party

External Affairs, Novartis

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Chair:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.