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LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT02132936
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : May 2, 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: Single (Investigator);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Interventions Drug: LEO 90100 aerosol foam
Drug: Aerosol foam vehicle
Drug: Calcipotriol BDP gel
Drug: Gel vehicle
Enrollment 504
Recruitment Details First Subject First Visit: 30-Jun-2014 Last Subject Last Visit: 04-Mar-2015
Pre-assignment Details A total of 504 subjects were enrolled, 41 enrolled subjects were not randomised. 463 subjects were randomised as follows: 185 subjects to LEO 90100, 188 to calcipotriol BDP gel, 47 to foam vehicle, and 43 to gel vehicle
Arm/Group Title LEO 90100 Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle
Hide Arm/Group Description LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
Period Title: Overall Study
Started 185 47 188 43
Completed 175 38 174 29
Not Completed 10 9 14 14
Arm/Group Title LEO 90100 Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle Total
Hide Arm/Group Description

LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks

LEO 90100 aerosol foam

Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks

Aerosol foam vehicle

Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks

Calcipotriol BDP gel

Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks

Gel vehicle

Total of all reporting groups
Overall Number of Baseline Participants 185 47 188 43 463
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants 47 participants 188 participants 43 participants 463 participants
54.0  (14.5) 54.6  (14.2) 54.5  (14.9) 51.9  (15.5) 54.1  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 47 participants 188 participants 43 participants 463 participants
Female
59
  31.9%
18
  38.3%
74
  39.4%
17
  39.5%
168
  36.3%
Male
126
  68.1%
29
  61.7%
114
  60.6%
26
  60.5%
295
  63.7%
1.Primary Outcome
Title Treatment Success According to the PGA
Hide Description

To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris.

Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician’s Global Assessment of Disease Severity (PGA).

‘Treatment success’ was defined as achieving ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline and ‘clear’ for subjects with ‘mild’ disease at baseline.

Time Frame 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 90100 Calcipotriol BDP Gel
Hide Arm/Group Description:
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Overall Number of Participants Analyzed 185 188
Measure Type: Number
Unit of Measure: percentage of subjects
38.3 22.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 90100, Calcipotriol BDP Gel
Comments

Mantel-Haenszel odds of treatment success in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.

Multiple imputation was used to handle missing PGA values.

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 2.55
Confidence Interval (2-Sided) 95%
1.46 to 4.46
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.
Time Frame Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 90100 Calcipotriol BDP Gel
Hide Arm/Group Description:

LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks

LEO 90100 aerosol foam

Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks

Calcipotriol BDP gel

Overall Number of Participants Analyzed 185 188
Measure Type: Number
Unit of Measure: percentage of subjects
52.1 34.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 90100, Calcipotriol BDP Gel
Comments

Mantel-Haenszel odds of having PASI 75 in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.

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 Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.18
Confidence Interval (2-Sided) 95%
1.37 to 3.47
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to ‘Treatment Success’ According to PGA.
Hide Description

Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success.

‘Treatment success’ was defined as achieving ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline and ‘clear’ for subjects with ‘mild’ disease at baseline.

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 90100 Calcipotriol BDP Gel
Hide Arm/Group Description:
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Overall Number of Participants Analyzed 185 188
Median (Inter-Quartile Range)
Unit of Measure: weeks
6 [1] 
(4 to NA)
NA [2] 
(6 to NA)
[1]
Upper quartile could not be estimated as less than 75% of subjects achieved treatment success.
[2]

Median could not be estimated for the calcipotriol BDP gel group as less than 50% of subjects achieved treatment success.

Upper quartile could not be estimated as less than 75% of subjects achieved treatment success.

Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 90100, Calcipotriol BDP Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).
Hide Description Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 90100 Aerosol Foam Vehicle
Hide Arm/Group Description:
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks

Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks

Aerosol foam vehicle

Overall Number of Participants Analyzed 185 47
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-30.5
(-33.4 to -27.5)
-15.9
(-21.3 to -10.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 90100, Aerosol Foam Vehicle
Comments Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for 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 ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).
Hide Description Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
Time Frame Baseline to Week 4; Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 90100 Calcipotriol BDP Gel
Hide Arm/Group Description:
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Overall Number of Participants Analyzed 185 188
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-30.5
(-33.4 to -27.5)
-28.5
(-31.4 to -25.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LEO 90100, Calcipotriol BDP Gel
Comments Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.33
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Day 0 until week 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LEO 90100 Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle
Hide Arm/Group Description

LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks

LEO 90100 aerosol foam

Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks

Aerosol foam vehicle

Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks

Calcipotriol BDP gel

Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks

Gel vehicle

All-Cause Mortality
LEO 90100 Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LEO 90100 Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/185 (2.16%)      0/47 (0.00%)      3/188 (1.60%)      1/43 (2.33%)    
Cardiac disorders         
Cardiac failure congestive  1/185 (0.54%)  0/47 (0.00%)  0/188 (0.00%)  0/43 (0.00%) 
Gastrointestinal disorders         
Gastrooesophageal reflux disease  1/185 (0.54%)  0/47 (0.00%)  0/188 (0.00%)  0/43 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  0/185 (0.00%)  0/47 (0.00%)  0/188 (0.00%)  1/43 (2.33%) 
Injury, poisoning and procedural complications         
Post procedural haemorrhage  0/185 (0.00%)  0/47 (0.00%)  1/188 (0.53%)  0/43 (0.00%) 
Metabolism and nutrition disorders         
Type 2 diabetes mellitus  0/185 (0.00%)  0/47 (0.00%)  1/188 (0.53%)  0/43 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate cancer  1/185 (0.54%)  0/47 (0.00%)  0/188 (0.00%)  0/43 (0.00%) 
Nervous system disorders         
Ischaemic stroke  0/185 (0.00%)  0/47 (0.00%)  1/188 (0.53%)  0/43 (0.00%) 
Skin and subcutaneous tissue disorders         
Psoriasis  1/185 (0.54%)  0/47 (0.00%)  0/188 (0.00%)  0/43 (0.00%) 
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
LEO 90100 Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/185 (33.51%)      25/47 (53.19%)      60/188 (31.91%)      28/43 (65.12%)    
Cardiac disorders         
Angina pectoris  0/185 (0.00%)  0 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Atrial fibrillation  0/185 (0.00%)  0 0/47 (0.00%)  0 0/188 (0.00%)  0 1/43 (2.33%)  1
Gastrointestinal disorders         
Diarrhoea  4/185 (2.16%)  4 0/47 (0.00%)  0 2/188 (1.06%)  2 2/43 (4.65%)  2
Gastrooesophageal reflux disease  2/185 (1.08%)  2 1/47 (2.13%)  1 1/188 (0.53%)  1 0/43 (0.00%)  0
Nausea  2/185 (1.08%)  2 0/47 (0.00%)  0 2/188 (1.06%)  2 1/43 (2.33%)  1
Abdominal pain upper  0/185 (0.00%)  0 0/47 (0.00%)  0 0/188 (0.00%)  0 1/43 (2.33%)  1
General disorders         
Application site pruritus  1/185 (0.54%)  1 2/47 (4.26%)  2 1/188 (0.53%)  1 1/43 (2.33%)  1
Influenza like illness  3/185 (1.62%)  3 0/47 (0.00%)  0 2/188 (1.06%)  2 1/43 (2.33%)  1
Application site pain  0/185 (0.00%)  0 1/47 (2.13%)  1 0/188 (0.00%)  0 1/43 (2.33%)  1
Feeling cold  0/185 (0.00%)  0 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Infections and infestations         
Nasopharyngitis  7/185 (3.78%)  7 0/47 (0.00%)  0 4/188 (2.13%)  4 2/43 (4.65%)  2
Upper respiratory tract infection  5/185 (2.70%)  6 1/47 (2.13%)  1 9/188 (4.79%)  9 2/43 (4.65%)  2
Lower respiratory tract infection  4/185 (2.16%)  4 0/47 (0.00%)  0 1/188 (0.53%)  1 1/43 (2.33%)  1
Sinusitis  2/185 (1.08%)  2 0/47 (0.00%)  0 3/188 (1.60%)  3 1/43 (2.33%)  1
Gastroenteritis  1/185 (0.54%)  1 1/47 (2.13%)  1 1/188 (0.53%)  1 0/43 (0.00%)  0
Tooth abscess  1/185 (0.54%)  1 1/47 (2.13%)  1 1/188 (0.53%)  1 1/43 (2.33%)  1
Intertrigo candida  0/185 (0.00%)  0 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Cellulitis  0/185 (0.00%)  0 0/47 (0.00%)  0 0/188 (0.00%)  0 1/43 (2.33%)  1
Nail infection  0/185 (0.00%)  0 0/47 (0.00%)  0 0/188 (0.00%)  0 1/43 (2.33%)  1
Injury, poisoning and procedural complications         
Fall  0/185 (0.00%)  0 0/47 (0.00%)  0 1/188 (0.53%)  1 1/43 (2.33%)  1
Investigations         
Vitamin D decreased  2/185 (1.08%)  2 1/47 (2.13%)  1 3/188 (1.60%)  3 1/43 (2.33%)  1
Metabolism and nutrition disorders         
Vitamin D deficiency  6/185 (3.24%)  6 0/47 (0.00%)  0 5/188 (2.66%)  5 2/43 (4.65%)  2
Musculoskeletal and connective tissue disorders         
Back pain  5/185 (2.70%)  5 1/47 (2.13%)  1 3/188 (1.60%)  3 2/43 (4.65%)  2
Joint swelling  0/185 (0.00%)  0 0/47 (0.00%)  0 1/188 (0.53%)  1 1/43 (2.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon adenoma  0/185 (0.00%)  0 0/47 (0.00%)  0 0/188 (0.00%)  0 1/43 (2.33%)  1
Nervous system disorders         
Headache  2/185 (1.08%)  2 2/47 (4.26%)  2 1/188 (0.53%)  1 1/43 (2.33%)  1
Renal and urinary disorders         
Renal failure chronic  0/185 (0.00%)  0 1/47 (2.13%)  1 1/188 (0.53%)  1 0/43 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Nasal congestion  0/185 (0.00%)  0 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Pulmonary congestion  0/185 (0.00%)  0 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Sinus congestion  0/185 (0.00%)  0 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Cough  1/185 (0.54%)  1 1/47 (2.13%)  1 2/188 (1.06%)  2 1/43 (2.33%)  1
Skin and subcutaneous tissue disorders         
Pruritus  5/185 (2.70%)  6 1/47 (2.13%)  1 2/188 (1.06%)  2 0/43 (0.00%)  0
Psoriasis  4/185 (2.16%)  4 1/47 (2.13%)  1 7/188 (3.72%)  8 0/43 (0.00%)  0
Blister  1/185 (0.54%)  1 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Dry skin  1/185 (0.54%)  1 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Eythema  1/185 (0.54%)  1 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Dermatitis contact  0/185 (0.00%)  0 1/47 (2.13%)  1 0/188 (0.00%)  0 0/43 (0.00%)  0
Vascular disorders         
Hypertension  2/185 (1.08%)  2 0/47 (0.00%)  0 7/188 (3.72%)  7 0/43 (0.00%)  0
Haematoma  0/185 (0.00%)  0 0/47 (0.00%)  0 0/188 (0.00%)  0 1/43 (2.33%)  1
1
Term from vocabulary, MedDRA (15.1)
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
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02132936     History of Changes
Other Study ID Numbers: LP0053-1003
First Submitted: May 6, 2014
First Posted: May 7, 2014
Results First Submitted: February 4, 2016
Results First Posted: May 2, 2016
Last Update Posted: September 18, 2019