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

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ClinicalTrials.gov Identifier: NCT00733954
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : August 20, 2009
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: clobetasol propionate spray
Drug: clobetasol propionate ointment
Enrollment 250
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).
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide 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
Reason Not Completed
Lost to Follow-up             5             2
Protocol Violation             1             0
Withdrawal by Subject             2             0
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment Total
Hide Arm/Group Description clobetasol propionate spray 0.05% clobetasol propionate ointment 0.05% Total of all reporting groups
Overall Number of Baseline Participants 124 125 249
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 125 participants 249 participants
50.6  (14.0) 50.2  (13.5) 50.4  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 125 participants 249 participants
Female
52
  41.9%
43
  34.4%
95
  38.2%
Male
72
  58.1%
82
  65.6%
154
  61.8%
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT), Last observation carried forward (LOCF)
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
62 44
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
39 44
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
50 33
4.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
29 33
5.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
53 72
6.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
48 52
7.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
53 33
8.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
73 72
9.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
72 52
10.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
48 32
11.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
56 43
12.Secondary Outcome
Title Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
55 35
13.Secondary Outcome
Title Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment
Hide Description Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Mean (Standard Deviation)
Unit of Measure: % 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Mean (Standard Deviation)
Unit of Measure: % 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Mean (Standard Deviation)
Unit of Measure: % 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Mean (Standard Deviation)
Unit of Measure: % 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Mean (Standard Deviation)
Unit of Measure: % 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Mean (Standard Deviation)
Unit of Measure: % 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide Arm/Group Description:
clobetasol propionate spray 0.05%
clobetasol propionate ointment 0.05%
Overall Number of Participants Analyzed 124 125
Measure Type: Number
Unit of Measure: Participants
1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clobetasol Propionate Spray Clobetasol Propionate Ointment
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clobetasol Propionate Spray Clobetasol Propionate Ointment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)   0/123 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clobetasol Propionate Spray Clobetasol Propionate Ointment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)   0/123 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ronald W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5358
EMail: ron.gottschalk@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00733954     History of Changes
Other Study ID Numbers: US10012
First Submitted: August 11, 2008
First Posted: August 13, 2008
Results First Submitted: April 30, 2009
Results First Posted: August 20, 2009
Last Update Posted: May 15, 2014