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

• 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 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
• 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 [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
• Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
• Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
• Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
• Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ] [ Designated as safety issue: No ]
• Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
• Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: No ]
• Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ] [ Designated as safety issue: Yes ]

• Overall Disease Severity after 2 weeks of treatment and at 2 weeks post indicated treatment (week 4 for clobetasol propionate ointment group and week 6 for clobetasol propionate spray group) [ Time Frame: 4 weeks and 6 weeks ] [ Designated as safety issue: No ]
• Signs of Psoriasis after two weeks of treatment, end of treatment, and at two weeks post treatment [ Time Frame: 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
• Percent change from baseline in body surface area (%BSA affected and treated) after two weeks of treatment, end of treatment and at two weeks post treatment [ Time Frame: 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
• Tolerability assessments and adverse events [ Time Frame: 4 weeks and 6 weeks ] [ Designated as safety issue: Yes ]

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.

Same as above.

• Drug: clobetasol propionate spray
  Apply twice daily
  Other Name: Clobex® Spray
• Drug: clobetasol propionate ointment
  Apply twice daily
  Other Name: clobetasol propionate ointment

• Active Comparator: clobetasol propionate spray
  clobetasol propionate spray 0.05%
  Intervention: Drug: clobetasol propionate spray
• Active Comparator: clobetasol propionate ointment
  clobetasol propionate ointment 0.05%
  Intervention: Drug: clobetasol propionate ointment

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