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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437255
First Posted: February 19, 2007
Last Update Posted: April 7, 2008
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.
Information provided by:
Galderma Laboratories, L.P.
February 16, 2007
February 19, 2007
April 7, 2008
August 2006
June 2007   (Final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00437255 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis
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
Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
Same as above.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: Clobetasol Propionate, 0.05%
    Topical, twice daily for 4 weeks
    Other Name: Clobex® Spray
  • Drug: Calcipotriene and betamethasone dipropionate ointment
    Topical, once daily
    Other Name: Taclonex® Ointment
  • Active Comparator: 1
    Clobex® Spray
    Intervention: Drug: Clobetasol Propionate, 0.05%
  • Active Comparator: 2
    Taclonex® Ointment
    Intervention: Drug: Calcipotriene and betamethasone dipropionate ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
June 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00437255
US10034
No
Not Provided
Not Provided
Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
Not Provided
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, LP
Galderma Laboratories, L.P.
April 2008

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