Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT00658788
- Lead Sponsor
- Galderma R&D
- 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.
- Detailed Description
Same as above.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 305
- Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
- Overall Disease Severity of at least 3 (moderate)
- Surface area involvement too large (>20% BSA)
- Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Treatment clobetasol propionate spray 0.05% 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 Study Treatment calcitriol ointment 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
- Primary Outcome Measures
Name Time Method Overall Disease Severity Success (ODS) 8 and 12 weeks Success was defined as a one-grade improvement in ODS from baseline.
- Secondary Outcome Measures
Name Time Method Signs of Psoriasis - Erythema 2, 4, 8 and 12 weeks Percent Change From Baseline in Body Surface Area (% BSA) Affected 2, 4, 8 and 12 weeks Overall Disease Severity 2, 4, 8 and 12 weeks Signs of Psoriasis - Scaling 2, 4, 8 and 12 weeks Tolerability Assessment - Pruritus Baseline, 2, 4, 8 and 12 weeks Global Improvement Score 2, 4, 8 and 12 weeks Tolerability Assessment - Telangiectasias Baseline, 2, 4, 8 and 12 weeks Tolerability Assessment - Stinging/ Burning Baseline, 2, 4, 8 and 12 weeks Tolerability Assessment - Folliculitis Baseline, 2, 4, 8 and 12 weeks Signs of Psoriasis - Plaque Elevation 2, 4, 8 and 12 weeks Tolerability Assessment - Skin Atrophy Baseline, 2, 4, 8 and 12 weeks
Trial Locations
- Locations (12)
J&J Studies, Inc
🇺🇸College Station, Texas, United States
Mount Sinai Department of Dermatology
🇺🇸New York, New York, United States
Virginia Clinical Research, Inc
🇺🇸Norfolk, Virginia, United States
Gwinnett Clinical Research Center, Inc
🇺🇸Snellville, Georgia, United States
MedaPhase, Inc.
🇺🇸Newnan, Georgia, United States
Northeastern Ohio Universities College of Medicine
🇺🇸Warren, Ohio, United States
Hudson Dermatology
🇺🇸Evansville, Indiana, United States
Madison Skin and Research, Inc
🇺🇸Madison, Wisconsin, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Suzanne Bruce and Associates, PA
🇺🇸Houston, Texas, United States
Dermatology Associates of Seattle, PLLC
🇺🇸Seattle, Washington, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States