A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis - Tabular View

Tracking Information

First Received Date ^ICMJE

April 23, 2008

Last Updated Date

July 9, 2008

Start Date ^ICMJE

October 2002

Primary Completion Date

November 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Eczema Area and Severity Index (EASI) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00666302 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Investigator's Global Atopic Dermatitis Assessment (IGADA) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Patient's evaluation of itch [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Body surface area affected [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis

Official Title ^ICMJE

A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis

Brief Summary

A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Dermatitis, Atopic

Intervention ^ICMJE

Drug: tacrolimus ointment
Drug: pimecrolimus cream

Study Arms / Comparison Groups

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

413

Completion Date

November 2003

Primary Completion Date

November 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
Negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

Skin disorder other than Atopic Dermatitis in the areas to be treated
Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
Clinically infected Atopic Dermatitis at baseline
Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
Known hypersensitivity to macrolides or any excipient of either study medication
Chronic condition which is either not stable or not well controlled
Pregnant or breast feeding an infant

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00666302

Responsible Party

Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc.

Study ID Numbers ^ICMJE

20-02-004

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use central contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

July 2008

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