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

This study has been completed.

First Received: February 16, 2007 Last Updated: March 27, 2008 History of Changes

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00436540

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Clobetasol Propionate 0.05% Spray Drug: Clobetasol Propionate 0.05% Foam	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Clobetasol Clobetasol propionate

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Efficacy - Body Surface Area, Investigator Global Severity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety - Tolerability assessments, adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	78
Study Start Date:	March 2006
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator clobetasol propionate (Clobex®) spray	Drug: Clobetasol Propionate 0.05% Spray Apply to affected areas twice daily
2: Active Comparator clobetasol propionate (Olux®) foam	Drug: Clobetasol Propionate 0.05% Foam Apply to affected areas twice daily

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436540

Locations

United States, California
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Missouri
Central Dermatology, PC
St. Louis, Missouri, United States, 63117

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W. Gottschalk, MD

Galderma Laboratories, LP

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10013
Study First Received:	February 16, 2007
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00436540 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Clobetasol
Skin Diseases
Psoriasis
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010