Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis - Full Text View

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00658788

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: clobetasol propionate spray 0.05% Drug: calcitriol ointment	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Clobetasol Clobetasol propionate Calcitriol

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Percent of Subjects with an improvement from baseline in Overall Disease Severity score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy - Percent of Subjects with an improvement from baseline in Overall Disease Severity score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Efficacy - Overall Disease Severity, Global Improvement Score, Signs of Psoriasis, Percent change from baseline in Body Surface Area [ Time Frame: 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
Efficacy - Koo-Menter Psoriasis Qualify of Life Questionnaire; Subject Satisfaction Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety - Tolerability, adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	305
Study Start Date:	March 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

clobetasol propionate spray, 0.05%, applied topically twice daily

Other Name: Clobex® Spray 0.05%

calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Other Name: Calcitriol Ointment

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658788

Locations

United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Georgia
MedaPhase, Inc.
Newnan, Georgia, United States, 30263
Gwinnett Clinical Research Center, Inc
Snellville, Georgia, United States, 30078
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, New York
Mount Sinai Department of Dermatology
New York, New York, United States, 10029
United States, Ohio
Northeastern Ohio Universities College of Medicine
Warren, Ohio, United States, 44483
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73069
United States, Texas
J&J Studies, Inc
College Station, Texas, United States, 77840
Suzanne Bruce and Associates, PA
Houston, Texas, United States, 75390
United States, Virginia
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507
United States, Washington
Dermatology Associates of Seattle, PLLC
Seattle, Washington, United States, 98101
United States, Wisconsin
Madison Skin and Research, Inc
Madison, Wisconsin, United States, 53719

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:	Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00658788 History of Changes
Other Study ID Numbers:	US10085
Study First Received:	March 4, 2008
Last Updated:	August 31, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Clobetasol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012