Trial Outcomes & Findings for Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis (NCT NCT00733954)

NCT ID: NCT00733954

Last Updated: 2022-08-23

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 250 participants
• Primary outcome timeframe: Baseline and Week 2 and Baseline and Week 4
• Results posted on: 2022-08-23

Participant Flow

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.

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).

Participant milestones

Measure	Clobetasol Propionate Spray clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment clobetasol propionate ointment 0.05%
Overall Study STARTED	124	125
Overall Study COMPLETED	116	123
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Measure	Clobetasol Propionate Spray clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment clobetasol propionate ointment 0.05%
Overall Study Lost to Follow-up	5	2
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%	Total n=249 Participants Total of all reporting groups
Age, Continuous	50.6 years STANDARD_DEVIATION 14.0 • n=93 Participants	50.2 years STANDARD_DEVIATION 13.5 • n=4 Participants	50.4 years STANDARD_DEVIATION 13.7 • n=27 Participants
Sex: Female, Male Female	52 Participants n=93 Participants	43 Participants n=4 Participants	95 Participants n=27 Participants
Sex: Female, Male Male	72 Participants n=93 Participants	82 Participants n=4 Participants	154 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 2 and Baseline and Week 4

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

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
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	44 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
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	44 Participants

SECONDARY outcome

Timeframe: Baseline and Week 4 and Baseline and Week 6

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
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	33 Participants

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: ITT, LOCF

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

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment	29 Participants	33 Participants

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: ITT, LOCF

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

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment	53 Participants	72 Participants

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: ITT, LOCF

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

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment	48 Participants	52 Participants

SECONDARY outcome

Timeframe: Baseline and Week 2 and Baseline and Week 4

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment	53 Participants	33 Participants

SECONDARY outcome

Timeframe: Baseline and Week 2 and Baseline and Week 4

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment	73 Participants	72 Participants

SECONDARY outcome

Timeframe: Baseline and Week 2 and Baseline and Week 4

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment	72 Participants	52 Participants

SECONDARY outcome

Timeframe: Baseline and Week 4 and Baseline and Week 6

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment	48 Participants	32 Participants

SECONDARY outcome

Timeframe: Baseline and Week 4 and Baseline and Week 6

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment	56 Participants	43 Participants

SECONDARY outcome

Timeframe: Baseline and Week 4 and Baseline and Week 6

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment	55 Participants	35 Participants

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: ITT, LOCF

Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment	28.6 % BSA Standard Deviation 28	35.9 % BSA Standard Deviation 30.5

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: ITT, LOCF

Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment	29.1 % BSA Standard Deviation 29.6	38.4 % BSA Standard Deviation 33.0

SECONDARY outcome

Timeframe: Baseline and Week 2 and Baseline and Week 4

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment	51 % BSA Standard Deviation 36.5	35.9 % BSA Standard Deviation 30.5

SECONDARY outcome

Timeframe: Baseline and Week 2 and Baseline and Week 4

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment	52 % BSA Standard Deviation 37.5	38.4 % BSA Standard Deviation 33.0

SECONDARY outcome

Timeframe: Baseline and Week 4 and Baseline and Week 6

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment	48 % BSA Standard Deviation 36.3	37.6 % BSA Standard Deviation 34.4

SECONDARY outcome

Timeframe: Baseline and Week 4 and Baseline and Week 6

Population: ITT, LOCF

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment	48.6 % BSA Standard Deviation 38.0	38.3 % BSA Standard Deviation 37.9

SECONDARY outcome

Timeframe: Baseline and Week 4 and Baseline and Week 6

Population: Safety

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)

Outcome measures

Measure	Clobetasol Propionate Spray n=124 Participants clobetasol propionate spray 0.05%	Clobetasol Propionate Ointment n=125 Participants clobetasol propionate ointment 0.05%
Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment	1 Participants	0 Participants

Adverse Events

Clobetasol Propionate Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clobetasol Propionate Ointment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronald W. Gottschalk, MD / Medical Director

Galderma Laboratories, L.P.

Phone: 817-961-5358

Email: ron.gottschalk@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER