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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 4

Number 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

Page last updated: August 23, 2015

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