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

Registration Number
NCT00437255
Lead Sponsor
Galderma R&D
Brief Summary

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

Detailed Description

Same as above.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
122
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Clobetasol Propionate, 0.05%Clobex® Spray
2Calcipotriene and betamethasone dipropionate ointmentTaclonex® Ointment
Primary Outcome Measures
NameTimeMethod
Overall Disease SeverityEnd of treatment (Week 4)
Tolerability assessments, incidence of adverse eventsBaseline, Weeks 1, 2, 4 and 8
Secondary Outcome Measures
NameTimeMethod
Overall Disease SeverityWeeks 1, 2 and 8
Investigator Global AssessmentEnd of treatment (week 4) and Weeks 1, 2 and 8

Trial Locations

Locations (4)

Minnesota Clinical Study Center

🇺🇸

Fridley, Minnesota, United States

J & S Studies, Inc.

🇺🇸

Bryan, Texas, United States

Baylor Research Institute

🇺🇸

Dallas, Texas, United States

DermResearch, Inc.

🇺🇸

Austin, Texas, United States

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