A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam

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

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.

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: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Efficacy - Body Surface Area, Investigator Global Severity

Secondary outcome: Safety - Tolerability assessments, adverse events

Detailed description: Same as above.

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

Solano Clinical Research, Vallejo, California 94589, United States

Central Dermatology, PC, St. Louis, Missouri 63117, United States

Starting date: March 2006
Ending date: January 2007
Last updated: March 27, 2008