Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis - Tabular View

Tracking Information

First Received Date ^ICMJE

February 16, 2007

Last Updated Date

April 3, 2008

Start Date ^ICMJE

August 2006

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall Disease Severity [ Time Frame: End of treatment (Week 4) ] [ Designated as safety issue: No ]
Tolerability assessments, incidence of adverse events [ Time Frame: Baseline, Weeks 1, 2, 4 and 8 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00437255 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Disease Severity [ Time Frame: Weeks 1, 2 and 8 ] [ Designated as safety issue: No ]
Investigator Global Assessment [ Time Frame: End of treatment (week 4) and Weeks 1, 2 and 8 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis

Official Title ^ICMJE

An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis

Brief Summary

Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.

Detailed Description

Same as above.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Plaque Psoriasis

Intervention ^ICMJE

Drug: Clobetasol Propionate, 0.05%
Drug: Calcipotriene and betamethasone dipropionate ointment

Study Arms / Comparison Groups

Active Comparator: Clobex® Spray
Active Comparator: Taclonex® Ointment

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

122

Completion Date

June 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Moderate to severe psoriasis involving 3-20% of the body surface area

Exclusion Criteria:

Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment
Subjects having psoriasis that involves the scalp, face, or groin

Gender

Both

Ages

18 Years to 80 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

NCT00437255

Responsible Party

Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.

Study ID Numbers ^ICMJE

US10034

Study Sponsor ^ICMJE

Galderma Laboratories, L.P.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, LP

Information Provided By

Galderma Laboratories, L.P.

Verification Date

April 2008

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