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Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

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: Psoriasis

Intervention: clobetasol propionate spray 0.05% (Drug); calcitriol ointment (Drug)

Phase: Phase 3

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 objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Clinical Details

Official title: A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Disease Severity Success (ODS)

Secondary outcome:

Global Improvement Score

Signs of Psoriasis - Erythema

Signs of Psoriasis - Scaling

Signs of Psoriasis - Plaque Elevation

Percent Change From Baseline in Body Surface Area (% BSA) Affected

Overall Disease Severity

Tolerability Assessment - Pruritus

Tolerability Assessment - Telangiectasias

Tolerability Assessment - Stinging/ Burning

Tolerability Assessment - Skin Atrophy

Tolerability Assessment - Folliculitis

Detailed description: Same as above.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body

surface area

- Overall Disease Severity of at least 3 (moderate)

Exclusion Criteria:

- Surface area involvement too large (>20% BSA)

- Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

Locations and Contacts

Therapeutics Clinical Research, San Diego, California 92123, United States

MedaPhase, Inc., Newnan, Georgia 30263, United States

Gwinnett Clinical Research Center, Inc, Snellville, Georgia 30078, United States

Hudson Dermatology, Evansville, Indiana 47714, United States

Mount Sinai Department of Dermatology, New York, New York 10029, United States

Northeastern Ohio Universities College of Medicine, Warren, Ohio 44483, United States

Central Sooner Research, Norman, Oklahoma 73069, United States

J&J Studies, Inc, College Station, Texas 77840, United States

Suzanne Bruce and Associates, PA, Houston, Texas 75390, United States

Virginia Clinical Research, Inc, Norfolk, Virginia 23507, United States

Dermatology Associates of Seattle, PLLC, Seattle, Washington 98101, United States

Madison Skin and Research, Inc, Madison, Wisconsin 53719, United States

Additional Information

Starting date: March 2008
Last updated: August 12, 2014

Page last updated: August 23, 2015

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