Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00689481
First received: May 29, 2008
Last updated: April 5, 2012
Last verified: April 2012
Results First Received: November 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: U0267 Foam
Drug: Vehicle foam

  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
No text entered.

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
Calcipotriene Foam Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Vehicle Foam Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

Participant Flow:   Overall Study
    Calcipotriene Foam     Vehicle Foam  
STARTED     214     109  
COMPLETED     190     95  
NOT COMPLETED     24     14  
Adverse Event                 7                 1  
Lost to Follow-up                 4                 3  
Lack of Efficacy                 4                 3  
Non-compliance with study treatment                 1                 1  
Withdrawal by Subject                 8                 4  
Excluded medication started during study                 0                 1  
Subject early term, left on vacation                 0                 1  



  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
Calcipotriene Foam Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Vehicle Foam Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Total Total of all reporting groups

Baseline Measures
    Calcipotriene Foam     Vehicle Foam     Total  
Number of Participants  
[units: participants]
  214     109     323  
Age  
[units: years]
Mean ± Standard Deviation
  47.9  ± 14.2     47.5  ± 16.9     47.8  ± 15.2  
Age, Customized  
[units: participants]
     
12 to < 18 years     2     3     5  
18 to < 65 years     185     88     273  
> 65 years     27     18     45  
Gender  
[units: participants]
     
Female     108     59     167  
Male     106     50     156  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     10     3     13  
Black     5     4     9  
Mulitracial     4     2     6  
Native Hawaiian or Other Pacific Islander     1     1     2  
White     194     99     293  
Disease Characteristic - Erythema [1]
[units: participants]
     
Light red coloration     52     30     82  
Moderate red coloration     158     76     234  
Bright red coloration     4     3     7  
Disease Characteristic - Scaling [2]
[units: participants]
     
Minimal     1     0     1  
Mild     65     33     98  
Moderate     145     76     221  
Marked     2     0     2  
Severe     1     0     1  
Disease Characteristic - Plaque Thickness [3]
[units: participants]
     
Possible but difficult to ascertain     1     1     2  
Slight but definite elevation     66     41     107  
Moderate elevation     144     66     210  
Marked elevation     2     1     3  
Very marked elevation     1     0     1  
Disease Characteristic - Target Lesion Location [4]
[units: participants]
     
Arm     53     27     80  
Leg     129     55     184  
Trunk     32     27     59  
Disease Characteristic - Investigator Static Global Assesssment (ISGA) [5]
[units: participants]
     
Mild     56     31     87  
Moderate     158     78     236  
Disease Characteristic - Subject's Global Assessment [6]
[units: participants]
     
Almost clear     2     2     4  
Mild     18     9     27  
Moderate     62     26     88  
Very noticeable     96     55     151  
Severe     36     17     53  
Disease Characteristic - Percent BSA (extent of psoriasis) [7]
[units: percentage]
Mean ± Standard Deviation
  6.3  ± 4.7     6.4  ± 5.2     6.4  ± 4.9  
[1] Disease characteristics of Erythema at baseline
[2] Disease characteristics of Scaling at baseline
[3] Disease characteristics of Plaque Thickness at baseline
[4] Disease characteristics of Target Lesion Location at baseline
[5] Disease characteristics of ISGA at baseline
[6] Disease characteristics of Subject's Global Assessment at baseline
[7] Disease characteristics of Percent of BSA (extent of psoriasis) at baseline



  Outcome Measures
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1.  Primary:   Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment   [ Time Frame: 8 weeks ]

2.  Secondary:   Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8   [ Time Frame: 8 Weeks ]

3.  Secondary:   Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2-grade Improvement From Baseline at Week 8   [ Time Frame: 8 Weeks ]

4.  Secondary:   Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8   [ Time Frame: 8 Weeks ]

5.  Secondary:   Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8   [ Time Frame: 8 Weeks ]

6.  Secondary:   Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)   [ Time Frame: 8 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  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 by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00689481     History of Changes
Other Study ID Numbers: 114742, U0267-302
Study First Received: May 29, 2008
Results First Received: November 5, 2010
Last Updated: April 5, 2012
Health Authority: United States: Food and Drug Administration