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Trial record 64 of 273 for:    Betamethasone

LEO 90100 in the Treatment of 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: NCT01536938
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : December 9, 2015
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Interventions Drug: LEO 90100
Drug: Calcipotriol
Drug: Betamethasone
Enrollment 303
Recruitment Details First Subject First Visit: 07-MAY-2012 Last Subject Last Visit: 10-OCT-2012
Pre-assignment Details Prior to randomisation, the subjects entered a washout phase (if required) where antipsoriatic treatm. and other relevant medication/treatms. had to be discontin. 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 Betamethasone Dipropionate Calcipotriol Aerosol Foam
Hide Arm/Group Description

LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

Applied once daily for up to 4 weeks

Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)

Applied once daily for up to 4 weeks

Calcipotriol aerosol foam: calcipotriol 50 mcg/g.

Applied once daily for up to 4 weeks

Period Title: Overall Study
Started 100 101 101
Completed 94 94 93
Not Completed 6 7 8
Arm/Group Title LEO 90100 Betamethasone Dipropionate Calcipotriol Aerosol Foam Total
Hide Arm/Group Description LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 100 101 101 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 101 participants 101 participants 302 participants
47.4  (14.8) 49.0  (14.4) 50.7  (14.7) 49.0  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 101 participants 302 participants
Female
47
  47.0%
45
  44.6%
40
  39.6%
132
  43.7%
Male
53
  53.0%
56
  55.4%
61
  60.4%
170
  56.3%
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 Betamethasone Dipropionate Calcipotriol Aerosol Foam
Hide Arm/Group Description:
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
Overall Number of Participants Analyzed 100 101 101
Measure Type: Number
Unit of Measure: participants
45 31 15
Time Frame [Not Specified]
Adverse Event Reporting Description A total of 101 patients were randomized to each study arm - "Betamethasone Dipropionate" and "Calcipotriol Aerosol Foam". However, two of the subjects in each arm had not applied any study medication and therefore the safety analysis included only the 99 subjects that used the study medication in the respective arm.
 
Arm/Group Title LEO 90100 Betamethasone Dipropionate Calcipotriol Aerosol Foam
Hide Arm/Group Description LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
All-Cause Mortality
LEO 90100 Betamethasone Dipropionate Calcipotriol Aerosol Foam
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LEO 90100 Betamethasone Dipropionate Calcipotriol Aerosol Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/100 (1.00%)      0/99 (0.00%)      0/99 (0.00%)    
Immune system disorders       
Hypersensitivity  1/100 (1.00%)  1 0/99 (0.00%)  0 0/99 (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 Betamethasone Dipropionate Calcipotriol Aerosol Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      0/99 (0.00%)      0/99 (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
Other Publications:
Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, Olesen M, Lowson D, Yamauchi P. A novel aerosol foam formulation of calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) is more efficacious than Cal and BD foam alone in treating psoriasis vulgaris: a randomized, double-blind, multicenter, three-arm, Phase II study. J Am Acad Dermatol. 2015:72 Suppl 1;AB222 (P1670).
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01536938     History of Changes
Other Study ID Numbers: LEO 90100-7
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: May 9, 2016