Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00670241
First received: April 29, 2008
Last updated: October 21, 2013
Last verified: February 2011
Results First Received: November 23, 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: Psoriasis Vulgaris
Interventions: Drug: calcipotriol and betamethasone (LEO 80185 gel)
Drug: LEO 80185 vehicle
Drug: Tacalcitol 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
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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
Calcipotriol Plus Betamethasone Dipropionate Gel Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
Tacalcitol Ointment Tacalcitol Ointment for up to 8 weeks
Gel Vehicle Gel Vehicle for up to 8 weeks

Participant Flow:   Overall Study
    Calcipotriol Plus Betamethasone Dipropionate Gel     Tacalcitol Ointment     Gel Vehicle  
STARTED     183     184     91  
COMPLETED     171     163     64  
NOT COMPLETED     12     21     27  



  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.
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Reporting Groups
  Description
Calcipotriol Plus Betamethasone Dipropionate Gel Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
Tacalcitol Ointment Tacalcitol Ointment for up to 8 weeks
Gel Vehicle Gel Vehicle for up to 8 weeks
Total Total of all reporting groups

Baseline Measures
    Calcipotriol Plus Betamethasone Dipropionate Gel     Tacalcitol Ointment     Gel Vehicle     Total  
Number of Participants  
[units: participants]
  183     184     91     458  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     148     155     74     377  
>=65 years     35     29     17     81  
Age  
[units: years]
Mean ± Standard Deviation
  50.9  ± 14.3     51.7  ± 13.4     52.8  ± 14.9     51.6  ± 14.0  
Gender  
[units: participants]
       
Female     66     69     38     173  
Male     117     115     53     285  
Region of Enrollment  
[units: participants]
       
Canada     183     184     91     458  



  Outcome Measures
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1.  Primary:   Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8   [ Time Frame: Week 8 ]

2.  Secondary:   Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4   [ Time Frame: Week 4 ]

3.  Secondary:   The Percentage Change in PASI From Baseline to Week 8   [ Time Frame: Baseline, Week 4 and 8 ]

4.  Secondary:   Subjects With Relapse During the Study   [ Time Frame: Week 8-16 ]

5.  Secondary:   Subjects With Rebound During the Study   [ Time Frame: Week 8-16 ]


  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 NOT 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.


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
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Results Point of Contact:  
Name/Title: Anders Rhod Larsen, Scientific Advisor
Organization: LEO Pharma
phone: +4572262990
e-mail: anders.larsen@leo-pharma.com


No publications provided


Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00670241     History of Changes
Other Study ID Numbers: LEO 80185-G21
Study First Received: April 29, 2008
Results First Received: November 23, 2010
Last Updated: October 21, 2013
Health Authority: Canada: Health Canada