Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
Information source: Galderma Laboratories, L.P.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scalp Psoriasis
Intervention: clobetasol propionate spray 0.05% (Drug); Vehicle spray (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Galderma Laboratories, L.P. Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.
Overall contact:
Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Global Severity Score of Scalp Psoriasis
Secondary outcome: Scalp Psoriasis Individual Sign ScoresExtent of Scalp Involvement Index Pruritus
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com
Dermatology Research Associates, Los Angeles, California 90045, United States; Completed
Hudson Dermatology, Evansville, Indiana 47714, United States; Completed
Research Division of The Skin Specialty Group, New York, New York 10155, United States; Recruiting
Saonjie Hamilton, Phone: 212-223-6986, Email: research.cookbolden@gmail.com
Fran E Cook-Bolden, MD, Principal Investigator
Dermatology Associates, PLLC, Seattle, Washington 98101, United States; Recruiting
Trish Otto, LPN, CCRC, Phone: 206-315-0377, Email: totto@daseattle.com
Bernard S Goffe, MD, Principal Investigator
Additional Information
Starting date: April 2009
Ending date: June 2009
Last updated: October 2, 2009
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