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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:
ClinicalTrials.gov Identifier:
NCT00670241
First Posted: May 1, 2008
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LEO Pharma
Results First Submitted: November 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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 
Overall Participants Analyzed 
[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


  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 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.


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



Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00670241     History of Changes
Other Study ID Numbers: LEO 80185-G21
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: November 23, 2010
Results First Posted: March 8, 2011
Last Update Posted: April 14, 2015