Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LEO 90100 Compared to 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: NCT01866163
Recruitment Status : Completed
First Posted : May 31, 2013
Results First Posted : May 9, 2016
Last Update Posted : September 18, 2019
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: Vehicle
Enrollment 426
Recruitment Details First Subject First Visit: 17-Jun-2013 Last Subject Last Visit: 02-Oct-2013
Pre-assignment Details Prior to randomisation, the subject entered a washout phase (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The wash-out/screening phase could last for up to 4 weeks, depending on which disallowed treatments the subject received.
Arm/Group Title LEO 90100 Vehicle
Hide Arm/Group Description LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) Aerosol foam vehicle
Period Title: Overall Study
Started 323 103
Completed 313 99
Not Completed 10 4
Arm/Group Title LEO 90100 Vehicle Total
Hide Arm/Group Description LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) Aerosol foam vehicle Total of all reporting groups
Overall Number of Baseline Participants 323 103 426
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 323 participants 103 participants 426 participants
51.2  (13.9) 46.0  (13.2) 50.0  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 323 participants 103 participants 426 participants
Female
119
  36.8%
54
  52.4%
173
  40.6%
Male
204
  63.2%
49
  47.6%
253
  59.4%
1.Primary Outcome
Title Treatment Success According to IGA
Hide Description

Subjects with ‘treatment success’ (‘clear’ or ‘almost clear’ for subjects with at least moderate disease at baseline, ‘clear’ for subjects with mild disease at baseline) according to the Investigators’ global assessment of disease severity (IGA) at Week 4.

The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects were included in the full analysis set and analysed for efficacy.
Arm/Group Title LEO 90100 Vehicle
Hide Arm/Group Description:
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Aerosol foam vehicle
Overall Number of Participants Analyzed 323 103
Measure Type: Number
Unit of Measure: percentage of subjects
53.3 4.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 90100, Vehicle
Comments Multiple imputations were used to handle missing data.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 30.27
Confidence Interval (2-Sided) 95%
9.72 to 94.30
Estimation Comments [Not Specified]
2.Secondary Outcome
Title m-PASI at Week 4
Hide Description

The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).

m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.

The m-PASI score range from 0 (best) to 64.8 (worst).

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects were included in the full analysis set and analysed for efficacy.
Arm/Group Title LEO 90100 Vehicle
Hide Arm/Group Description:
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Aerosol foam vehicle
Overall Number of Participants Analyzed 323 103
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
2.04
(1.74 to 2.35)
5.33
(4.79 to 5.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 90100, Vehicle
Comments The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.28
Confidence Interval (2-Sided) 95%
-3.90 to -2.67
Estimation Comments [Not Specified]
3.Secondary Outcome
Title m-PASI at Week 1
Hide Description

The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).

m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.

The m-PASI score range from 0 (best) to 64.8 (worst).

Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects were included in the full analysis set and analysed for efficacy.
Arm/Group Title LEO 90100 Vehicle
Hide Arm/Group Description:
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Aerosol foam vehicle
Overall Number of Participants Analyzed 323 103
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
4.66
(4.41 to 4.90)
5.93
(5.50 to 6.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 90100, Vehicle
Comments The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-1.76 to -0.78
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LEO 90100 Vehicle
Hide Arm/Group Description LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) Aerosol foam vehicle
All-Cause Mortality
LEO 90100 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LEO 90100 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/323 (0.62%)      0/103 (0.00%)    
Psychiatric disorders     
Substance induced psychotic disorder  1/323 (0.31%)  1 0/103 (0.00%)  0
Bipolar disorder  1/323 (0.31%)  1 0/103 (0.00%)  0
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.6%
LEO 90100 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/323 (5.57%)      15/103 (14.56%)    
Gastrointestinal disorders     
Diarrhoea  2/323 (0.62%)  2 1/103 (0.97%)  1
Nausea  2/323 (0.62%)  2 0/103 (0.00%)  0
General disorders     
Application site pain 1 [1]  3/323 (0.93%)  4 2/103 (1.94%)  2
Application site dryness  0/323 (0.00%)  0 1/103 (0.97%)  1
Application site erosion  0/323 (0.00%)  0 1/103 (0.97%)  1
Application site erythema  0/323 (0.00%)  0 1/103 (0.97%)  1
Application site oedema  0/323 (0.00%)  0 1/103 (0.97%)  1
Infections and infestations     
Nasopharyngitis  6/323 (1.86%)  6 0/103 (0.00%)  0
Eye infection  0/323 (0.00%)  0 1/103 (0.97%)  1
Gastroenteritis viral  0/323 (0.00%)  0 1/103 (0.97%)  1
Streptococcal infection  0/323 (0.00%)  0 1/103 (0.97%)  1
Injury, poisoning and procedural complications     
Ligament sprain  0/323 (0.00%)  0 1/103 (0.97%)  1
Sunburn  0/323 (0.00%)  0 1/103 (0.97%)  1
Investigations     
Blood pressure increased  3/323 (0.93%)  4 0/103 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Flank pain  2/323 (0.62%)  2 0/103 (0.00%)  0
Pain in extremity  0/323 (0.00%)  0 1/103 (0.97%)  1
Nervous system disorders     
Dizziness  0/323 (0.00%)  0 1/103 (0.97%)  1
Skin and subcutaneous tissue disorders     
Angioedema  0/323 (0.00%)  0 1/103 (0.97%)  1
1
Term from vocabulary, MedDRA (16.0)
[1]
General disorders and administration site conditions
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 results of the trial, irrespective of outcome. Pubs/presentations by investigator(s) shall not be made before the results of a joint publication is public. 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
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01866163     History of Changes
Other Study ID Numbers: LP0053-1001
First Submitted: May 28, 2013
First Posted: May 31, 2013
Results First Submitted: November 13, 2015
Results First Posted: May 9, 2016
Last Update Posted: September 18, 2019