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A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00852761
First received: February 25, 2009
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
Results First Received: November 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Plaque-Type Psoriasis
Interventions: Drug: Olux-E Foam
Drug: Clobex lotion

  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
Clinical research center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Olux-E Foam Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
Clobex Lotion Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.

Participant Flow:   Overall Study
    Olux-E Foam     Clobex Lotion  
STARTED     17     17  
COMPLETED     17     17  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Olux-E Foam Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
Clobex Lotion Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
Total Total of all reporting groups

Baseline Measures
    Olux-E Foam     Clobex Lotion     Total  
Number of Participants  
[units: participants]
 		  17     17     34  
Age, Customized  
[units: years]
Mean ± Standard Deviation 		  48.2  ± 11.7     48.6  ± 13     48.4  ± 12.2  
Gender  
[units: participants]
 		     
Female     6     8     14  
Male     11     9     20  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     2     3  
White     16     15     31  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     17     17     34  
Body Mass Index [1]
[units: kg/m^2]
Mean ± Standard Deviation 		  31.2  ± 6.4     30.0  ± 8.8     30.6  ± 7.6  
[1] Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women and is measured in kg/m^2.



  Outcome Measures
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1.  Primary:   At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)   [ Time Frame: Baseline to day 15 ]
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2.  Secondary:   At Least 1 Grade Improvement Psoriasis Grading Scale   [ Time Frame: Baseline, days 3 and 8 ]
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3.  Secondary:   At Least a 2 Grade Improvement Psoriasis Grading Scale   [ Time Frame: Baseline, days 3, 8, 15 ]
  Show Outcome Measure 3

4.  Secondary:   At Least a 3 Grade Improvement Psoriasis Grading Scale   [ Time Frame: Baseline, days 3, 8, 15 ]
  Show Outcome Measure 4

5.  Secondary:   At Least 1 Grade Improvement in the Psoriasis Global Assessment   [ Time Frame: Baseline, days 3, 8, 15 ]
  Show Outcome Measure 5

6.  Secondary:   At Least a 2 Grade Improvement in the Psoriasis Global Assessment   [ Time Frame: Baseline, days 3, 8, 15 ]
  Show Outcome Measure 6

7.  Secondary:   At Least a 3 Grade Improvement in the Psoriasis Global Assessment   [ Time Frame: Baseline, days 3, 8, 15 ]
  Show Outcome Measure 7

8.  Secondary:   At Least 1 Grade Improvement in Subject’s Global Assessment   [ Time Frame: Baseline, days 3, 8, 15 ]
  Show Outcome Measure 8

9.  Secondary:   At Least a 2 Grade Improvement in Subject's Global Assessment   [ Time Frame: Baseline, days 3, 8, 15 ]
  Show Outcome Measure 9

10.  Secondary:   At Least a 3 Grade Improvement in Subject's Global Assessment   [ Time Frame: Baseline, days 3, 8, 15 ]
  Show Outcome Measure 10

11.  Secondary:   Median Change in Psoriasis Grading Scale   [ Time Frame: Baseline, Days 3, 8, 15 ]
  Show Outcome Measure 11

12.  Secondary:   Dermatology Quality of Life - Symptoms and Feelings   [ Time Frame: Baseline, Days 3, 8, 15 ]
  Show Outcome Measure 12

13.  Secondary:   Dermatology Quality of Life - Daily Activities   [ Time Frame: Baseline, Days 3, 8, 15 ]
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14.  Secondary:   Dermatology Quality of Life - Leisure   [ Time Frame: Baseline, Days 3, 8, 15 ]
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15.  Secondary:   Dermatology Quality of Life - Work and School   [ Time Frame: Baseline, Days 3, 8, 15 ]
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16.  Secondary:   Dermatology Quality of Life - Personal Relationships   [ Time Frame: Baseline, Days 3, 8, 15 ]
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17.  Secondary:   Dermatology Quality of Life - Treatment   [ Time Frame: Baseline, Days 3, 8, 15 ]
  Show Outcome Measure 17

18.  Secondary:   Total Dermatology Life Quality Index (DLQI) Score   [ Time Frame: Baseline, Days 3, 8, 15 ]
  Show Outcome Measure 18

19.  Secondary:   Dermatology Life Quality Index (DLQI) Categories   [ Time Frame: Days 3, 8, 15 ]
  Show Outcome Measure 19


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00852761     History of Changes
Other Study ID Numbers: 114569, U0280-402
Study First Received: February 25, 2009
Results First Received: November 4, 2010
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board