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

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ClinicalTrials.gov Identifier: NCT00658788
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: clobetasol propionate spray 0.05% Drug: calcitriol ointment Phase 3

Detailed Description:
Same as above.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Study Treatment

clobetasol propionate spray 0.05%

Other Names:

Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily

calcitriol ointment

Other Names:

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

 Drug: clobetasol propionate spray 0.05%
clobetasol propionate spray, 0.05%, applied topically twice daily
Other Name: Clobex® Spray 0.05%

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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Disease Severity Success (ODS) [ Time Frame: 8 and 12 weeks ]
    Success was defined as a one-grade improvement in ODS from baseline.


Secondary Outcome Measures :
  1. Global Improvement Score [ Time Frame: 2, 4, 8 and 12 weeks ]
  2. Signs of Psoriasis - Erythema [ Time Frame: 2, 4, 8 and 12 weeks ]
  3. Signs of Psoriasis - Scaling [ Time Frame: 2, 4, 8 and 12 weeks ]
  4. Signs of Psoriasis - Plaque Elevation [ Time Frame: 2, 4, 8 and 12 weeks ]
  5. Percent Change From Baseline in Body Surface Area (% BSA) Affected [ Time Frame: 2, 4, 8 and 12 weeks ]
  6. Overall Disease Severity [ Time Frame: 2, 4, 8 and 12 weeks ]
  7. Tolerability Assessment - Pruritus [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
  8. Tolerability Assessment - Telangiectasias [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
  9. Tolerability Assessment - Stinging/ Burning [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
  10. Tolerability Assessment - Skin Atrophy [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
  11. Tolerability Assessment - Folliculitis [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658788


Locations
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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
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Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
More Information
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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00658788     History of Changes
Other Study ID Numbers: US10085
First Posted: April 15, 2008    Key Record Dates
Results First Posted: August 27, 2014
Last Update Posted: August 27, 2014
Last Verified: September 2012
Additional relevant MeSH terms:
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Calcitriol
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists