Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

This study has been completed.

First Received: April 13, 2009 Last Updated: January 4, 2010 History of Changes

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00881868

Purpose

The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.

Condition	Intervention	Phase
Scalp Psoriasis	Drug: clobetasol propionate spray 0.05% Drug: Vehicle spray	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Clobetasol Propionate Spray Versus Vehicle for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

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:

Global Severity Score of Scalp Psoriasis [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scalp Psoriasis Individual Sign Scores [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Extent of Scalp Involvement Index [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Pruritus [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	April 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Clobex Spray: Active Comparator	Drug: clobetasol propionate spray 0.05% Apply twice daily to affected areas
Vehicle spray: Placebo Comparator	Drug: Vehicle spray Apply twice daily to affected areas

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp

Exclusion Criteria:

Subjects who need systemic treatment for their body psoriasis
Subjects who have surface area involvement too large (>20% BSA) that would require more than 50 grams per week of study product

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881868

Locations

United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, New York
Research Division of The Skin Specialty Group
New York, New York, United States, 10155
United States, Washington
Dermatology Associates, PLLC
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10118
Study First Received:	April 13, 2009
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00881868 History of Changes
Health Authority:	United States: Food and Drug Administration

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