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

This study is currently recruiting participants.

Verified by Galderma Laboratories, L.P., April 2009

First Received: April 13, 2009 Last Updated: April 14, 2009 History of Changes

Sponsored by:	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

MedlinePlus related topics: Psoriasis

Drug Information available for: Clobetasol Clobetasol propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, 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

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 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

Contacts

Contact: Luz E Colon, MS

817-961-5243

lucy.colon@galderma.com

Locations

United States, California
Dermatology Research Associates	Recruiting
Los Angeles, California, United States, 90045
Contact: Evelyn Miranda 310-337-7171 emiranda@drsofen.com
Principal Investigator: Howard L Sofen, MD
United States, Indiana
Hudson Dermatology	Recruiting
Evansville, Indiana, United States, 47714
Contact: Kim Morrison 812-477-2760 KMorrison22@att.net
Principal Investigator: Charles P Hudson, MD
United States, New York
Research Division of The Skin Specialty Group	Recruiting
New York, New York, United States, 10155
Contact: Saonjie Hamilton 212-223-6986 research.cookbolden@gmail.com
Principal Investigator: Fran E Cook-Bolden, MD
United States, Washington
Dermatology Associates, PLLC	Recruiting
Seattle, Washington, United States, 98101
Contact: Trish Otto, LPN, CCRC 206-315-0377 totto@daseattle.com
Principal Investigator: Bernard S Goffe, MD

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:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881868 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Clobetasol
Skin Diseases
Psoriasis
Hormone Antagonists

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

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 May 07, 2009