Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: August 25, 2016
Last verified: August 2016
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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 
[1] Disease characteristics of Erythema at baseline
Disease Characteristic - Scaling [1] 
[Units: Participants]
     
Minimal   1   0   1 
Mild   65   33   98 
Moderate   145   76   221 
Marked   2   0   2 
Severe   1   0   1 
[1] Disease characteristics of Scaling at baseline
Disease Characteristic - Plaque Thickness [1] 
[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 
[1] Disease characteristics of Plaque Thickness at baseline
Disease Characteristic - Target Lesion Location [1] 
[Units: Participants]
     
Arm   53   27   80 
Leg   129   55   184 
Trunk   32   27   59 
[1] Disease characteristics of Target Lesion Location at baseline
Disease Characteristic - Investigator Static Global Assesssment (ISGA) [1] 
[Units: Participants]
     
Mild   56   31   87 
Moderate   158   78   236 
[1] Disease characteristics of ISGA at baseline
Disease Characteristic - Subject's Global Assessment [1] 
[Units: Participants]
     
Almost clear   2   2   4 
Mild   18   9   27 
Moderate   62   26   88 
Very noticeable   96   55   151 
Severe   36   17   53 
[1] Disease characteristics of Subject's Global Assessment at baseline
Disease Characteristic - Percent BSA (extent of psoriasis) [1] 
[Units: Percentage]
Mean (Standard Deviation)
 6.3  (4.7)   6.4  (5.2)   6.4  (4.9) 
[1] Disease characteristics of Percent of BSA (extent of psoriasis) at baseline


  Outcome Measures
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00689481     History of Changes
Other Study ID Numbers: 114742
U0267-302 ( Other Identifier: Stiefel )
Study First Received: May 29, 2008
Results First Received: November 5, 2010
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration