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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00437255

Recruitment Status : Completed

First Posted : February 19, 2007

Last Update Posted : April 7, 2008

Sponsor:

Information provided by:

Galderma Laboratories, L.P.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: Clobetasol Propionate, 0.05% Drug: Calcipotriene and betamethasone dipropionate ointment	Phase 4

Detailed Description:

Same as above.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	122 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	August 2006
Actual Primary Completion Date :	June 2007
Actual Study Completion Date :	June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Drug Information available for: Betamethasone sodium phosphate Betamethasone Betamethasone valerate Betamethasone dipropionate Clobetasol propionate Calcipotriene Daivobet

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 Clobex® Spray	Drug: Clobetasol Propionate, 0.05% Topical, twice daily for 4 weeks Other Name: Clobex® Spray
Active Comparator: 2 Taclonex® Ointment	Drug: Calcipotriene and betamethasone dipropionate ointment Topical, once daily Other Name: Taclonex® Ointment

Outcome Measures

Primary Outcome Measures :

Overall Disease Severity [ Time Frame: End of treatment (Week 4) ]
Tolerability assessments, incidence of adverse events [ Time Frame: Baseline, Weeks 1, 2, 4 and 8 ]

Secondary Outcome Measures :

Overall Disease Severity [ Time Frame: Weeks 1, 2 and 8 ]
Investigator Global Assessment [ Time Frame: End of treatment (week 4) and Weeks 1, 2 and 8 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437255

Locations

Layout table for location information

United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J & S Studies, Inc.
Bryan, Texas, United States, 77802
Baylor Research Institute
Dallas, Texas, United States, 75230

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Layout table for investigator information

Study Director:	Ronald W Gottschalk, MD	Galderma Laboratories, LP

More Information

Layout table for additonal information

Responsible Party:	Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00437255
Other Study ID Numbers:	US10034
First Posted:	February 19, 2007 Key Record Dates
Last Update Posted:	April 7, 2008
Last Verified:	April 2008

Additional relevant MeSH terms:

Layout table for MeSH terms

Psoriasis Skin Diseases, Papulosquamous Skin Diseases Calcitriol Betamethasone Betamethasone Valerate Betamethasone-17,21-dipropionate Betamethasone benzoate Clobetasol Calcipotriene Betamethasone sodium phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists	Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Calcium-Regulating Hormones and Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents

To Top