Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00658788 |
Recruitment Status :
Completed
First Posted : April 15, 2008
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis | Drug: clobetasol propionate spray 0.05% Drug: calcitriol ointment | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 305 participants |
Allocation: | N/A |
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 |
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 |
- Overall Disease Severity Success (ODS) [ Time Frame: 8 and 12 weeks ]Success was defined as a one-grade improvement in ODS from baseline.
- Global Improvement Score [ Time Frame: 2, 4, 8 and 12 weeks ]
- Signs of Psoriasis - Erythema [ Time Frame: 2, 4, 8 and 12 weeks ]
- Signs of Psoriasis - Scaling [ Time Frame: 2, 4, 8 and 12 weeks ]
- Signs of Psoriasis - Plaque Elevation [ Time Frame: 2, 4, 8 and 12 weeks ]
- Percent Change From Baseline in Body Surface Area (% BSA) Affected [ Time Frame: 2, 4, 8 and 12 weeks ]
- Overall Disease Severity [ Time Frame: 2, 4, 8 and 12 weeks ]
- Tolerability Assessment - Pruritus [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
- Tolerability Assessment - Telangiectasias [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
- Tolerability Assessment - Stinging/ Burning [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
- Tolerability Assessment - Skin Atrophy [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
- Tolerability Assessment - Folliculitis [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Ronald W Gottschalk, MD | Galderma Laboratories, L.P. |
Responsible Party: | Galderma Laboratories, L.P. |
ClinicalTrials.gov Identifier: | NCT00658788 |
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 |
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 |