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

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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
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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
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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 ]

Eligibility Criteria
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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
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
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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
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
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Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00437255     History of Changes
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:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Clobetasol
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents