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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

Page last updated: August 23, 2015

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