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The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01139580
First received: June 6, 2010
Last updated: February 23, 2012
Last verified: February 2012
Results First Received: August 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Calcipotriene 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
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Reporting Groups
  Description
Calcipotriene Foam Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.
Vehicle Foam Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.

Participant Flow:   Overall Study
    Calcipotriene Foam     Vehicle Foam  
STARTED     181     182  
COMPLETED     158     164  
NOT COMPLETED     23     18  
Adverse Event                 5                 4  
Lost to Follow-up                 9                 1  
Lack of Efficacy                 0                 2  
Withdrawal by Subject                 6                 9  
Used Excluded Medicine After Enrollment                 1                 0  
Did Not Meet Exclusion Criteria                 1                 0  
Misrandomized                 1                 0  
Beginning Study Exclusion Treatment                 0                 1  
Participant Randomization in Error                 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 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Vehicle Foam Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Calcipotriene Foam     Vehicle Foam     Total  
Number of Participants  
[units: participants]
  181     182     363  
Age  
[units: Years]
Mean ± Standard Deviation
  45.9  ± 15.3     44.4  ± 15.5     45.2  ± 15.4  
Gender  
[units: Participants]
     
Female     69     76     145  
Male     112     106     218  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     6     3     9  
Black     15     18     33  
Multiracial     1     1     2  
Native Hawaiian/Other Pacific Islander     0     0     0  
White     156     160     316  
Missing     1     0     1  



  Outcome Measures
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1.  Primary:   Number of Participants With an Investigator’s Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method   [ Time Frame: Week 8 ]

2.  Primary:   Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)   [ Time Frame: Week 8 ]

3.  Secondary:   Number of Participants 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: Baseline and Week 8 ]

4.  Secondary:   Number of Participants 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: Baseline and Week 8 ]

5.  Secondary:   Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8   [ Time Frame: Baseline and Week 8 ]

6.  Secondary:   Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8   [ Time Frame: Week 8 ]


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


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01139580     History of Changes
Other Study ID Numbers: 114743, U0267-303
Study First Received: June 6, 2010
Results First Received: August 18, 2011
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration