Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp
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: Scalp Psoriasis
Intervention: clobetasol propionate spray 0.05% (Drug); Vehicle spray (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, L.P.
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)
Secondary outcome: Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 Number of Participants in Each Category of Pruritus at Baseline and Week 4
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% Body Surface Area [BSA])
that would require more than 50 grams per week of study product
Locations and Contacts
Dermatology Research Associates, Los Angeles, California 90045, United States
Hudson Dermatology, Evansville, Indiana 47714, United States
Research Division of The Skin Specialty Group, New York, New York 10155, United States
Dermatology Associates, PLLC, Seattle, Washington 98101, United States
Additional Information
Starting date: April 2009
Last updated: September 21, 2012
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