Plaque Psoriasis
Conditions
Brief 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.
Detailed description
Same as above.
Interventions
DRUGclobetasol propionate spray
Apply twice daily
Apply twice daily
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and Week 2 and Baseline and Week 4 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and Week 4 and Baseline and Week 6 | 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) |
| Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment | Baseline and Week 2 | 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 |
| Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment | Baseline and Week 2 | 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 |
| Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment | Baseline and Week 2 | 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 |
| Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment | Baseline and Week 2 and Baseline and Week 4 | 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) |
| Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment | Baseline and Week 2 and Baseline and Week 4 | 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) |
| Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment | Baseline and Week 2 and Baseline and Week 4 | 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) |
| Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment | Baseline and Week 4 and Baseline and Week 6 | 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) |
| 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 | Baseline and Week 2 | 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 |
| Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment | Baseline and Week 4 and Baseline and Week 6 | 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) |
| Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment | Baseline and Week 2 | Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment |
| Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment | Baseline and Week 2 | Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment |
| Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment | Baseline and Week 2 and Baseline and Week 4 | 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) |
| Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment | Baseline and Week 2 and Baseline and Week 4 | 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) |
| Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment | Baseline and Week 4 and Baseline and Week 6 | 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) |
| Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment | Baseline and Week 4 and Baseline and Week 6 | 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) |
| Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment | Baseline and Week 4 and Baseline and Week 6 | 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) |
| Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment | Baseline and Week 4 and Baseline and Week 6 | 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) |
Countries
United States
Participant flow
Recruitment details
First subject was enrolled on August 22, 2007 and the last subject enrolled was February 20, 2008. Investigative sites were located at academic institutions and private physician offices.
Pre-assignment details
The specified wash-out period up to baseline was 14 days (topical steroid containing medication and/or UVB treatment, Dovonex, anthralin and/or tar); and 4 weeks (systemic corticosteroids, biologics and/or PUVA treatment).
Participants by arm
| Arm | Count |
|---|---|
| Clobetasol Propionate Spray clobetasol propionate spray 0.05% | 124 |
| Clobetasol Propionate Ointment clobetasol propionate ointment 0.05% | 125 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Clobetasol Propionate Spray | Clobetasol Propionate Ointment | Total |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 14 | 50.2 years STANDARD_DEVIATION 13.5 | 50.4 years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 52 Participants | 43 Participants | 95 Participants |
| Sex: Female, Male Male | 72 Participants | 82 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 122 | 0 / 123 |
| serious Total, serious adverse events | 0 / 122 | 0 / 123 |
Outcome results
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)
Time frame: Baseline and Week 2 and Baseline and Week 4
Population: Intent-to-treat (ITT), Last observation carried forward (LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | 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 | 62 Participants |
| Clobetasol Propionate Ointment | 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 | 44 Participants |
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)
Time frame: Baseline and Week 4 and Baseline and Week 6
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | 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 | 50 Participants |
| Clobetasol Propionate Ointment | 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 | 33 Participants |
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
Time frame: Baseline and Week 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | 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 | 39 Participants |
| Clobetasol Propionate Ointment | 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 | 44 Participants |
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
Time frame: Baseline and Week 2
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment | 29 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment | 33 Participants |
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)
Time frame: Baseline and Week 2 and Baseline and Week 4
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment | 53 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment | 33 Participants |
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)
Time frame: Baseline and Week 4 and Baseline and Week 6
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment | 48 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment | 32 Participants |
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
Time frame: Baseline and Week 2
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment | 48 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment | 52 Participants |
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)
Time frame: Baseline and Week 2 and Baseline and Week 4
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment | 72 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment | 52 Participants |
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)
Time frame: Baseline and Week 4 and Baseline and Week 6
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment | 55 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment | 35 Participants |
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
Time frame: Baseline and Week 2
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment | 53 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment | 72 Participants |
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)
Time frame: Baseline and Week 2 and Baseline and Week 4
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment | 73 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment | 72 Participants |
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)
Time frame: Baseline and Week 4 and Baseline and Week 6
Population: ITT, LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment | 56 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment | 43 Participants |
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)
Time frame: Baseline and Week 4 and Baseline and Week 6
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clobetasol Propionate Spray | Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment | 1 Participants |
| Clobetasol Propionate Ointment | Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment | 0 Participants |
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
Time frame: Baseline and Week 2
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clobetasol Propionate Spray | Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment | 28.6 % BSA | Standard Deviation 28 |
| Clobetasol Propionate Ointment | Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment | 35.9 % BSA | Standard Deviation 30.5 |
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)
Time frame: Baseline and Week 2 and Baseline and Week 4
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clobetasol Propionate Spray | Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment | 51 % BSA | Standard Deviation 36.5 |
| Clobetasol Propionate Ointment | Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment | 35.9 % BSA | Standard Deviation 30.5 |
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)
Time frame: Baseline and Week 4 and Baseline and Week 6
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clobetasol Propionate Spray | Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment | 48 % BSA | Standard Deviation 36.3 |
| Clobetasol Propionate Ointment | Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment | 37.6 % BSA | Standard Deviation 34.4 |
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
Time frame: Baseline and Week 2
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clobetasol Propionate Spray | Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment | 29.1 % BSA | Standard Deviation 29.6 |
| Clobetasol Propionate Ointment | Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment | 38.4 % BSA | Standard Deviation 33 |
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)
Time frame: Baseline and Week 2 and Baseline and Week 4
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clobetasol Propionate Spray | Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment | 52 % BSA | Standard Deviation 37.5 |
| Clobetasol Propionate Ointment | Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment | 38.4 % BSA | Standard Deviation 33 |
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)
Time frame: Baseline and Week 4 and Baseline and Week 6
Population: ITT, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clobetasol Propionate Spray | Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment | 48.6 % BSA | Standard Deviation 38 |
| Clobetasol Propionate Ointment | Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment | 38.3 % BSA | Standard Deviation 37.9 |