Trial Outcomes & Findings for LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris (NCT NCT01536886)
NCT ID: NCT01536886
Last Updated: 2025-03-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
376 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-03-07
Participant Flow
First Subject First Visit: 10-May-2012 Last Subject Last Visit: 19-Sep-2012
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
141
|
135
|
49
|
51
|
|
Overall Study
COMPLETED
|
136
|
127
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
LEO 90100
n=141 Participants
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
|
Calcipotriol Plus BDP Ointment
n=135 Participants
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
|
LEO 90100 Vehicle
n=49 Participants
Aerosol foam with no active ingredients
|
Ointment Vehicle
n=51 Participants
Ointment with no active ingredients
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
50.4 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
142 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeksAssessment 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.
Outcome measures
| Measure |
LEO 90100
n=141 Participants
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
|
Calcipotriol Plus BDP Ointment
n=135 Participants
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
|
LEO 90100 Vehicle
n=49 Participants
Aerosol foam with no active ingredients
|
Ointment Vehicle
n=51 Participants
Ointment with no active ingredients
|
|---|---|---|---|---|
|
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.
|
77 participants
|
58 participants
|
3 participants
|
4 participants
|
Adverse Events
LEO 90100
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Calcipotriol Plus BDP Ointment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
LEO 90100 Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ointment Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LEO 90100
n=141 participants at risk
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
|
Calcipotriol Plus BDP Ointment
n=134 participants at risk
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
|
LEO 90100 Vehicle
n=49 participants at risk
Aerosol foam with no active ingredients
|
Ointment Vehicle
n=51 participants at risk
Ointment with no active ingredients
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/141
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.
|
0.75%
1/134 • Number of events 1
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.
|
0.00%
0/49
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.
|
0.00%
0/51
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/141
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.
|
0.75%
1/134 • Number of events 1
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.
|
0.00%
0/49
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.
|
0.00%
0/51
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/141
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.
|
0.75%
1/134 • Number of events 1
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.
|
0.00%
0/49
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.
|
0.00%
0/51
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER