A Comparison Between Clobetasol Propionate 0.05% (Clobex�) Spray and Clobetasol Propionate 0.05% (Olux�) Foam
Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Clobetasol Propionate 0.05% Spray (Drug); Clobetasol Propionate 0.05% Foam (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Galderma Laboratories, L.P. Official(s) and/or principal investigator(s): Ronald W. Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, LP
Summary
The primary objective of this study is to evaluate the efficacy and safety of clobetasol
propionate 0. 05% (Clobex®) spray compared to clobetasol propionate 0. 05% (Olux®) foam.
Clinical Details
Official title: A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate (Olux®) Foam With Regard to Efficacy, Safety, Preference and Duration of Response in Stable Plaque Psoriasis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy - Body Surface Area, Investigator Global Severity
Secondary outcome: Safety - Tolerability assessments, adverse events
Detailed description:
Same as above.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must have a clinical diagnosis of moderate to severe plaque psoriasis,
defined as 3%-20% of the body surface area involved
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 50 grams per week of Olux® foam
- Subjects whose psoriasis involves the scalp, face or groin
- Subjects with non-plaque psoriasis or other related diseases not classified as plaque
psoriasis
Locations and Contacts
Solano Clinical Research, Vallejo, California 94589, United States
Central Dermatology, PC, St. Louis, Missouri 63117, United States
Additional Information
Starting date: March 2006
Last updated: March 27, 2008
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