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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658788
• Other study ID #: US10085
• Status: Completed
• Phase: Phase 3
• Start date: March 2008
• Est. completion date: January 2009

Study information

• Verified date: September 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Same as above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• clobetasol propionate spray 0.05%
clobetasol propionate spray, 0.05%, applied topically twice daily
• calcitriol ointment
calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Locations

Country	Name	City	State
United States	J&J Studies, Inc	College Station	Texas
United States	Hudson Dermatology	Evansville	Indiana
United States	Suzanne Bruce and Associates, PA	Houston	Texas
United States	Madison Skin and Research, Inc	Madison	Wisconsin
United States	Mount Sinai Department of Dermatology	New York	New York
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Virginia Clinical Research, Inc	Norfolk	Virginia
United States	Central Sooner Research	Norman	Oklahoma
United States	Therapeutics Clinical Research	San Diego	California
United States	Dermatology Associates of Seattle, PLLC	Seattle	Washington
United States	Gwinnett Clinical Research Center, Inc	Snellville	Georgia
United States	Northeastern Ohio Universities College of Medicine	Warren	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Disease Severity Success (ODS)	Success was defined as a one-grade improvement in ODS from baseline.	8 and 12 weeks
Secondary	Global Improvement Score		2, 4, 8 and 12 weeks
Secondary	Signs of Psoriasis - Erythema		2, 4, 8 and 12 weeks
Secondary	Signs of Psoriasis - Scaling		2, 4, 8 and 12 weeks
Secondary	Signs of Psoriasis - Plaque Elevation		2, 4, 8 and 12 weeks
Secondary	Percent Change From Baseline in Body Surface Area (% BSA) Affected		2, 4, 8 and 12 weeks
Secondary	Overall Disease Severity		2, 4, 8 and 12 weeks
Secondary	Tolerability Assessment - Pruritus		Baseline, 2, 4, 8 and 12 weeks
Secondary	Tolerability Assessment - Telangiectasias		Baseline, 2, 4, 8 and 12 weeks
Secondary	Tolerability Assessment - Stinging/ Burning		Baseline, 2, 4, 8 and 12 weeks
Secondary	Tolerability Assessment - Skin Atrophy		Baseline, 2, 4, 8 and 12 weeks
Secondary	Tolerability Assessment - Folliculitis		Baseline, 2, 4, 8 and 12 weeks