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

This study has been completed.
Sponsor:
Information provided by:
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00437255
First received: February 16, 2007
Last updated: April 3, 2008
Last verified: April 2008

February 16, 2007
April 3, 2008
August 2006
June 2007   (final data collection date for primary outcome measure)
  • 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 ]
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 ] [ 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00437255
US10034
No
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