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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00733954
• Collaborator: (none)
• Enrollment: 250
• Locations: 6
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 41.7
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: clobetasol propionate spray; Drug: clobetasol propionate ointment	Phase 4

Detailed Description

Same as above.

Study Design

• Study Type: Interventional
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: clobetasol propionate spray clobetasol propionate spray 0.05%	Drug: clobetasol propionate spray; Apply twice daily; Other Names: Clobex® Spray
Active Comparator: clobetasol propionate ointment clobetasol propionate ointment 0.05%	Drug: clobetasol propionate ointment; Apply twice daily

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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)

3. 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

4. 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

5. 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

6. 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)

7. 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)

8. 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)

9. 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)

10. 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)

11. 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)

12. 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

13. 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

14. 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)

15. 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)

16. 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)

17. 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)

18. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Bay Dermatology Medical Group, Inc.	Fremont	California	United States	94538
2	Solano Clinical Research	Vallejo	California	United States	94589
3	Henry Ford Medical Center	Detroit	Michigan	United States	48202
4	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
5	Dermatology Associates of Rochester	Rochester	New York	United States	14623
6	Baylor Research Institute - Dermatology Research	Dallas	Texas	United States	75246

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Ronald W Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT00733954
• Other Study ID Numbers: US10012
• First Posted: Aug 13, 2008
• Last Update Posted: Aug 23, 2022
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Psoriasis; Clobetasol

Study Results

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 Detail	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).

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Period Title: Overall Study
STARTED	124	125
COMPLETED	116	123
NOT COMPLETED	8	2

Baseline Characteristics

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment	Total
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%	Total of all reporting groups
Overall Participants	124	125	249
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.6 (14.0)	50.2 (13.5)	50.4 (13.7)
Sex: Female, Male (Count of Participants)
Female	52 41.9%	43 34.4%	95 38.2%
Male	72 58.1%	82 65.6%	154 61.8%

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT), Last observation carried forward (LOCF)

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	62 50%	44 35.2%

2. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	39 31.5%	44 35.2%

3. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	50 40.3%	33 26.4%

4. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	29 23.4%	33 26.4%

5. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	53 42.7%	72 57.6%

6. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	48 38.7%	52 41.6%

7. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	53 42.7%	33 26.4%

8. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	73 58.9%	72 57.6%

9. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	72 58.1%	52 41.6%

10. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	48 38.7%	32 25.6%

11. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	56 45.2%	43 34.4%

12. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	55 44.4%	35 28%

13. Secondary Outcome

Title	Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment
Description	Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment
Time Frame	Baseline and Week 2

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Mean (Standard Deviation) [% BSA]	28.6 (28)	35.9 (30.5)

14. Secondary Outcome

Title	Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Mean (Standard Deviation) [% BSA]	29.1 (29.6)	38.4 (33.0)

15. Secondary Outcome

Title	Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Mean (Standard Deviation) [% BSA]	51 (36.5)	35.9 (30.5)

16. Secondary Outcome

Title	Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Mean (Standard Deviation) [% BSA]	52 (37.5)	38.4 (33.0)

17. Secondary Outcome

Title	Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Mean (Standard Deviation) [% BSA]	48 (36.3)	37.6 (34.4)

18. Secondary Outcome

Title	Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

ITT, LOCF

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Mean (Standard Deviation) [% BSA]	48.6 (38.0)	38.3 (37.9)

19. Secondary Outcome

Title	Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment
Description	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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Clobetasol Propionate Spray	Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%	clobetasol propionate ointment 0.05%
Measure Participants	124	125
Number [Participants]	1 0.8%	0 0%

Adverse Events

Arm/Group Title	Clobetasol Propionate Spray		Clobetasol Propionate Ointment
Arm/Group Description	clobetasol propionate spray 0.05%		clobetasol propionate ointment 0.05%
All Cause Mortality
	Clobetasol Propionate Spray		Clobetasol Propionate Ointment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Clobetasol Propionate Spray		Clobetasol Propionate Ointment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/123 (0%)
Other (Not Including Serious) Adverse Events
	Clobetasol Propionate Spray		Clobetasol Propionate Ointment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/123 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The principal investigator has the right to publish or present the data results from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.