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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00733954
First received: August 11, 2008
Last updated: April 28, 2014
Last verified: April 2014
Results First Received: April 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Plaque Psoriasis
Interventions: Drug: clobetasol propionate spray
Drug: clobetasol propionate ointment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Clobetasol Propionate Spray clobetasol propionate spray 0.05%
Clobetasol Propionate Ointment clobetasol propionate ointment 0.05%

Participant Flow:   Overall Study
    Clobetasol Propionate Spray     Clobetasol Propionate Ointment  
STARTED     124     125  
COMPLETED     116     123  
NOT COMPLETED     8     2  
Lost to Follow-up                 5                 2  
Protocol Violation                 1                 0  
Withdrawal by Subject                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clobetasol Propionate Spray clobetasol propionate spray 0.05%
Clobetasol Propionate Ointment clobetasol propionate ointment 0.05%
Total Total of all reporting groups

Baseline Measures
    Clobetasol Propionate Spray     Clobetasol Propionate Ointment     Total  
Number of Participants  
[units: participants]
  124     125     249  
Age  
[units: years]
Mean ± Standard Deviation
  50.6  ± 14.0     50.2  ± 13.5     50.4  ± 13.7  
Gender  
[units: participants]
     
Female     52     43     95  
Male     72     82     154  



  Outcome Measures
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1.  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   [ Time Frame: Baseline and Week 2 and Baseline and Week 4 ]

2.  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   [ Time Frame: Baseline and Week 2 ]

3.  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   [ Time Frame: Baseline and Week 4 and Baseline and Week 6 ]

4.  Secondary:   Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment   [ Time Frame: Baseline and Week 2 ]

5.  Secondary:   Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment   [ Time Frame: Baseline and Week 2 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment   [ Time Frame: Baseline and Week 2 ]

14.  Secondary:   Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment   [ Time Frame: Baseline and Week 2 ]

15.  Secondary:   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 ]

16.  Secondary:   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 ]

17.  Secondary:   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 ]

18.  Secondary:   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 ]

19.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ronald W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
phone: 817-961-5358
e-mail: ron.gottschalk@galderma.com


No publications provided


Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00733954     History of Changes
Other Study ID Numbers: US10012
Study First Received: August 11, 2008
Results First Received: April 30, 2009
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board