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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. Identifier: NCT00437255
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : April 7, 2008
Information provided by:
Galderma Laboratories, L.P.

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.

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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

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

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

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

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.

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

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

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 identifier (NCT number): NCT00437255

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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.
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Study Director: Ronald W Gottschalk, MD Galderma Laboratories, LP
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Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P. 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:
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Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents