Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate Ointment With Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733954
• Other study ID #: US10012
• Status: Completed
• Phase: Phase 4
• Start date: August 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.

Description:

Same as above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas

• Overall disease severity is at least 3 (moderate)

Exclusion Criteria:

• Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment

• Subjects whose psoriasis involves only the scalp, face or groin

• Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• clobetasol propionate spray
Apply twice daily
• clobetasol propionate ointment
Apply twice daily

Locations

Country	Name	City	State
United States	Baylor Research Institute - Dermatology Research	Dallas	Texas
United States	Henry Ford Medical Center	Detroit	Michigan
United States	East Bay Dermatology Medical Group, Inc.	Fremont	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Associates of Rochester	Rochester	New York
United States	Solano Clinical Research	Vallejo	California

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	Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale	Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment)	Baseline and Week 2 and Baseline and Week 4
Secondary	Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale	Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst from Baseline to after 2 weeks of treatment	Baseline and Week 2
Secondary	Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale	Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment)	Baseline and Week 4 and Baseline and Week 6
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment	Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment	Baseline and Week 2
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment	Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment	Baseline and Week 2
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment	Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment	Baseline and Week 2
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment	Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)	Baseline and Week 2 and Baseline and Week 4
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment	Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)	Baseline and Week 2 and Baseline and Week 4
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment	Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)	Baseline and Week 2 and Baseline and Week 4
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment	Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)	Baseline and Week 4 and Baseline and Week 6
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment	Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)	Baseline and Week 4 and Baseline and Week 6
Secondary	Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment	Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)	Baseline and Week 4 and Baseline and Week 6
Secondary	Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment	Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment	Baseline and Week 2
Secondary	Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment	Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment	Baseline and Week 2
Secondary	Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment	Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)	Baseline and Week 2 and Baseline and Week 4
Secondary	Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment	Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)	Baseline and Week 2 and Baseline and Week 4
Secondary	Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment	Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)	Baseline and Week 4 and Baseline and Week 6
Secondary	Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment	Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)	Baseline and Week 4 and Baseline and Week 6
Secondary	Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment	Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)	Baseline and Week 4 and Baseline and Week 6