Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01536886
First received: February 16, 2012
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: November 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis Vulgaris
Interventions: Drug: LEO 90100
Drug: Betamethasone plus calcipotriol
Drug: Ointment vehicle
Drug: LEO 90100 vehicle

  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
First Subject First Visit: 10-May-2012 Last Subject Last Visit: 19-Sep-2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to random., the subjects entered a washout phase (if required) where antipsoriatic treatm. and other relevant medication/treatms. had to be discontinued as defined by the excl. criteria. Depending on prior use of disallowed treatms, the washout/screening phase could last for up to 4 w prior to the first admin. of investigational products.

Reporting Groups
  Description
LEO 90100 LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Calcipotriol Plus BDP Ointment Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
LEO 90100 Vehicle Aerosol foam with no active ingredients
Ointment Vehicle Ointment with no active ingredients

Participant Flow:   Overall Study
    LEO 90100     Calcipotriol Plus BDP Ointment     LEO 90100 Vehicle     Ointment Vehicle  
STARTED     141     135     49     51  
COMPLETED     136     127     47     48  
NOT COMPLETED     5     8     2     3  



  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
LEO 90100 LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Calcipotriol Plus BDP Ointment Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
LEO 90100 Vehicle Aerosol foam with no active ingredients
Ointment Vehicle Ointment with no active ingredients
Total Total of all reporting groups

Baseline Measures
    LEO 90100     Calcipotriol Plus BDP Ointment     LEO 90100 Vehicle     Ointment Vehicle     Total  
Number of Participants  
[units: participants]
  141     135     49     51     376  
Age  
[units: years]
Mean (Standard Deviation)
  50.9  (12.9)     50.6  (13.1)     45.8  (13.7)     52.6  (11.1)     50.4  (12.9)  
Gender  
[units: participants]
         
Female     54     48     19     21     142  
Male     87     87     30     30     234  



  Outcome Measures

1.  Primary:   Subjects With ‘Controlled Disease’ (‘Clear’/‘Almost Clear’ for Subjects w. at Least Moderate Disease at Baseline, ‘Clear’ for Subjects With Mild Disease at Baseline) According to the Investigator’s Global Assessment (IGA) on the Trunk and Limbs at Week 4.   [ Time Frame: 4 weeks ]


  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: Clinical Trial Disclosure Manager
Organization: LEO Pharma A/S
phone: +45 44945888
e-mail: ctr.disclosure@leo-pharma.com


Publications:
Koo J, Tyring S, Werschler WP, Bruce S, Olesen M, Villumsen J, Bagel J. Superior efficacy of the fixed combination calcipotriene plus betamethasone dipropionate in a novel aerosol foam versus ointment in patients with psoriasis vulgaris. Semin Cutan Med Surg. 2015;34 S1:PA-42.


Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01536886     History of Changes
Other Study ID Numbers: LEO 90100-35
Study First Received: February 16, 2012
Results First Received: November 2, 2015
Last Updated: December 22, 2015
Health Authority: United States: Food and Drug Administration