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Trial record 38 of 272 for:    Betamethasone

LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

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.
 
ClinicalTrials.gov Identifier: NCT01536886
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : December 9, 2015
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Interventions Drug: LEO 90100
Drug: Betamethasone plus calcipotriol
Drug: Ointment vehicle
Drug: LEO 90100 vehicle
Enrollment 376
Recruitment Details First Subject First Visit: 10-May-2012 Last Subject Last Visit: 19-Sep-2012
Pre-assignment Details 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.
Arm/Group Title LEO 90100 Calcipotriol Plus BDP Ointment LEO 90100 Vehicle Ointment Vehicle
Hide Arm/Group Description LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment Aerosol foam with no active ingredients Ointment with no active ingredients
Period Title: Overall Study
Started 141 135 49 51
Completed 136 127 47 48
Not Completed 5 8 2 3
Arm/Group Title LEO 90100 Calcipotriol Plus BDP Ointment LEO 90100 Vehicle Ointment Vehicle Total
Hide Arm/Group Description LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment Aerosol foam with no active ingredients Ointment with no active ingredients Total of all reporting groups
Overall Number of Baseline Participants 141 135 49 51 376
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants 135 participants 49 participants 51 participants 376 participants
50.9  (12.9) 50.6  (13.1) 45.8  (13.7) 52.6  (11.1) 50.4  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 135 participants 49 participants 51 participants 376 participants
Female
54
  38.3%
48
  35.6%
19
  38.8%
21
  41.2%
142
  37.8%
Male
87
  61.7%
87
  64.4%
30
  61.2%
30
  58.8%
234
  62.2%
1.Primary Outcome
Title 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.
Hide Description Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 90100 Calcipotriol Plus BDP Ointment LEO 90100 Vehicle Ointment Vehicle
Hide Arm/Group Description:
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
Aerosol foam with no active ingredients
Ointment with no active ingredients
Overall Number of Participants Analyzed 141 135 49 51
Measure Type: Number
Unit of Measure: participants
77 58 3 4
Time Frame [Not Specified]
Adverse Event Reporting Description A total of 135 patients were randomized to the "Calcipotriol Plus BDP Ointment" study arm. However, one of the subjects returned all study medication unopened and therefore the safety analysis included only the 134 subjects that used the study medication.
 
Arm/Group Title LEO 90100 Calcipotriol Plus BDP Ointment LEO 90100 Vehicle Ointment Vehicle
Hide Arm/Group Description LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment Aerosol foam with no active ingredients Ointment with no active ingredients
All-Cause Mortality
LEO 90100 Calcipotriol Plus BDP Ointment LEO 90100 Vehicle Ointment Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LEO 90100 Calcipotriol Plus BDP Ointment LEO 90100 Vehicle Ointment Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/141 (0.00%)      1/134 (0.75%)      0/49 (0.00%)      0/51 (0.00%)    
Hepatobiliary disorders         
Bile duct stone  0/141 (0.00%)  0 1/134 (0.75%)  1 0/49 (0.00%)  0 0/51 (0.00%)  0
Infections and infestations         
Bronchitis  0/141 (0.00%)  0 1/134 (0.75%)  1 0/49 (0.00%)  0 0/51 (0.00%)  0
Vascular disorders         
Hypertension  0/141 (0.00%)  0 1/134 (0.75%)  1 0/49 (0.00%)  0 0/51 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LEO 90100 Calcipotriol Plus BDP Ointment LEO 90100 Vehicle Ointment Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/141 (0.00%)      0/134 (0.00%)      0/49 (0.00%)      0/51 (0.00%)    
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.
LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: LEO Pharma A/S
Phone: +45 44945888
EMail: 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.
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01536886     History of Changes
Other Study ID Numbers: LEO 90100-35
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: November 2, 2015
Results First Posted: December 9, 2015
Last Update Posted: September 19, 2016