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

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00437255

Purpose

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

Condition	Intervention	Phase
Plaque Psoriasis	Drug: Clobetasol Propionate, 0.05% Drug: Calcipotriene and betamethasone dipropionate ointment	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Clobetasol Clobetasol propionate Calcipotriene Taclonex Bentelan Betamethasone Betamethasone dipropionate

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	122
Study Start Date:	August 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Clobex® Spray	Drug: Clobetasol Propionate, 0.05% Topical, twice daily for 4 weeks
2: Active Comparator Taclonex® Ointment	Drug: Calcipotriene and betamethasone dipropionate ointment Topical, once daily

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437255

Locations

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

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, LP

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10034
Study First Received:	February 16, 2007
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00437255 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Betamethasone-17,21-dipropionate
Respiratory System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Agonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Hormones
Calcitriol
Calcipotriene
Membrane Transport Modulators
Psoriasis
Therapeutic Uses

Vitamins
Vasoconstrictor Agents
Micronutrients
Betamethasone
Dermatologic Agents
Skin Diseases
Betamethasone sodium phosphate
Growth Substances
Anti-Asthmatic Agents
Cardiovascular Agents
Glucocorticoids
Pharmacologic Actions
Clobetasol
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 08, 2010