Trial Outcomes & Findings for A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris (NCT NCT01347255)
NCT ID: NCT01347255
Last Updated: 2025-03-07
Results Overview
TCS range from 0 (all signs absent) to 9 (all signs severe).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Day 1 (Baseline)/Day 29
Results posted on
2025-03-07
Participant Flow
First Subject First Visit: 12-MAY-2011 Last Subject Last Visit: 20-JUN-2011
The study was conducted with 3 successive individual phases: * Screening Phase (washout if applic.). A medical examination was performed at screening which took place 1-21 days before the start of the treatment phase (Day 1). * Treatment Phase (All patients (N=24) received all investigational medicinal products) * Follow-up Phase (if applic.)
Participant milestones
| Measure |
All Study Participants
All subjects received all four treatments:
1. LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
2. LEO 90100 cutaneous spray, ointment, vehicle w. betamethasone. Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
3. LEO 90100 cutaneous spray, ointment, vehicle. Served as a negative control for the two cutaneous spray ointments with active ingredients
4. Daivobet® ointment. Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Four test sites of approximately 5 cm2 were selected on predetermined psoriasis lesions (target plaques), delimited with a disposable circular device and mapped on a drawn figure.
The distance between two test sites was at least 2 cm. The products were applied on the four test sites (according to random assignment to specific test sites selected on the psoriasis plaque) once daily 6 days a week (except Sundays) for 4 weeks.
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|---|---|
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Overall Study
STARTED
|
24
|
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Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
LEO 90100 Cutaneous Spray, Ointment
n=24 Participants
Intra-Individual baseline analysis population, all treated with the following four products:
1. LEO 90100 cutaneous spray, ointment: once daily application, 4 weeks (6 days a week)
2. LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks (6 days a week)
3. LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4 weeks (6 days a week)
4. Daivobet® ointment: once daily application, 4 weeks (6 days a week)
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|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline)/Day 29Population: Intra-individual analysis population
TCS range from 0 (all signs absent) to 9 (all signs severe).
Outcome measures
| Measure |
LEO 90100 Cutaneous Spray, Ointment
n=24 Participants
LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone
n=24 Participants
Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle
n=24 Participants
LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
|
Daivobet® Ointment
n=24 Participants
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
|
|---|---|---|---|---|
|
Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline
|
-6.00 Scores on a scale
Standard Deviation 1.27
|
-4.96 Scores on a scale
Standard Deviation 1.85
|
-1.88 Scores on a scale
Standard Deviation 1.12
|
-5.25 Scores on a scale
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline. The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)). Negative changes in mean score represent improvement.
Outcome measures
| Measure |
LEO 90100 Cutaneous Spray, Ointment
n=24 Participants
LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone
n=24 Participants
Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle
n=24 Participants
LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
|
Daivobet® Ointment
n=24 Participants
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
|
|---|---|---|---|---|
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Change in Clinical Sign Scores
Infiltration (Day 4)
|
-0.13 units on a scale
Standard Deviation 0.30
|
-0.13 units on a scale
Standard Deviation 0.27
|
-0.08 units on a scale
Standard Deviation 0.19
|
-0.17 units on a scale
Standard Deviation 0.28
|
|
Change in Clinical Sign Scores
Infiltration (Day 22)
|
-1.85 units on a scale
Standard Deviation 0.50
|
-1.35 units on a scale
Standard Deviation 0.67
|
-0.38 units on a scale
Standard Deviation 0.42
|
-1.50 units on a scale
Standard Deviation 0.69
|
|
Change in Clinical Sign Scores
Erythema (Day 25)
|
-1.79 units on a scale
Standard Deviation 0.53
|
-1.44 units on a scale
Standard Deviation 0.68
|
-0.56 units on a scale
Standard Deviation 0.43
|
-1.56 units on a scale
Standard Deviation 0.68
|
|
Change in Clinical Sign Scores
Scaling (Day 25)
|
-2.15 units on a scale
Standard Deviation 0.50
|
-1.98 units on a scale
Standard Deviation 0.60
|
-0.85 units on a scale
Standard Deviation 0.38
|
-1.98 units on a scale
Standard Deviation 0.56
|
|
Change in Clinical Sign Scores
Infiltration (Day 25)
|
-2.10 units on a scale
Standard Deviation 0.49
|
-1.52 units on a scale
Standard Deviation 0.67
|
-0.44 units on a scale
Standard Deviation 0.37
|
-1.67 units on a scale
Standard Deviation 0.72
|
|
Change in Clinical Sign Scores
Erythema (Day 29)
|
-1.75 units on a scale
Standard Deviation 0.71
|
-1.44 units on a scale
Standard Deviation 0.78
|
-0.56 units on a scale
Standard Deviation 0.47
|
-1.50 units on a scale
Standard Deviation 0.66
|
|
Change in Clinical Sign Scores
Scaling (Day 29)
|
-2.13 units on a scale
Standard Deviation 0.47
|
-2.02 units on a scale
Standard Deviation 0.58
|
-0.90 units on a scale
Standard Deviation 0.47
|
-2.02 units on a scale
Standard Deviation 0.56
|
|
Change in Clinical Sign Scores
Infiltration (Day 29)
|
-2.13 units on a scale
Standard Deviation 0.45
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-1.50 units on a scale
Standard Deviation 0.77
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-0.42 units on a scale
Standard Deviation 0.43
|
-1.73 units on a scale
Standard Deviation 0.82
|
|
Change in Clinical Sign Scores
Erythema (Day 4)
|
-0.33 units on a scale
Standard Deviation 0.32
|
-0.33 units on a scale
Standard Deviation 0.32
|
-0.19 units on a scale
Standard Deviation 0.25
|
-0.33 units on a scale
Standard Deviation 0.32
|
|
Change in Clinical Sign Scores
Scaling (Day 4)
|
-0.17 units on a scale
Standard Deviation 0.35
|
-0.31 units on a scale
Standard Deviation 0.36
|
-0.19 units on a scale
Standard Deviation 0.25
|
-0.23 units on a scale
Standard Deviation 0.36
|
|
Change in Clinical Sign Scores
Erythema (Day 8)
|
-0.73 units on a scale
Standard Deviation 0.42
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-0.60 units on a scale
Standard Deviation 0.42
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-0.13 units on a scale
Standard Deviation 0.37
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-0.67 units on a scale
Standard Deviation 0.43
|
|
Change in Clinical Sign Scores
Scaling (Day 8)
|
-0.75 units on a scale
Standard Deviation 0.66
|
-0.81 units on a scale
Standard Deviation 0.59
|
-0.21 units on a scale
Standard Deviation 0.44
|
-0.73 units on a scale
Standard Deviation 0.64
|
|
Change in Clinical Sign Scores
Infiltration (Day 8)
|
-0.60 units on a scale
Standard Deviation 0.39
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-0.42 units on a scale
Standard Deviation 0.43
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-0.08 units on a scale
Standard Deviation 0.41
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-0.56 units on a scale
Standard Deviation 0.54
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|
Change in Clinical Sign Scores
Erythema (Day 11)
|
-1.08 units on a scale
Standard Deviation 0.46
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-0.75 units on a scale
Standard Deviation 0.42
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-0.29 units on a scale
Standard Deviation 0.39
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-0.83 units on a scale
Standard Deviation 0.52
|
|
Change in Clinical Sign Scores
Scaling (Day 11)
|
-1.29 units on a scale
Standard Deviation 0.67
|
-1.06 units on a scale
Standard Deviation 0.70
|
-0.46 units on a scale
Standard Deviation 0.49
|
-1.23 units on a scale
Standard Deviation 0.68
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|
Change in Clinical Sign Scores
Infiltration (Day 11)
|
-1.00 units on a scale
Standard Deviation 0.47
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-0.58 units on a scale
Standard Deviation 0.52
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-0.23 units on a scale
Standard Deviation 0.44
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-0.90 units on a scale
Standard Deviation 0.55
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|
Change in Clinical Sign Scores
Erythema (Day 15)
|
-1.29 units on a scale
Standard Deviation 0.41
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-1.06 units on a scale
Standard Deviation 0.52
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-0.33 units on a scale
Standard Deviation 0.43
|
-1.04 units on a scale
Standard Deviation 0.55
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|
Change in Clinical Sign Scores
Scaling (Day 15)
|
-1.65 units on a scale
Standard Deviation 0.63
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-1.40 units on a scale
Standard Deviation 0.59
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-0.46 units on a scale
Standard Deviation 0.41
|
-1.40 units on a scale
Standard Deviation 0.61
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|
Change in Clinical Sign Scores
Infiltration (Day 15)
|
-1.31 units on a scale
Standard Deviation 0.44
|
-0.85 units on a scale
Standard Deviation 0.52
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-0.23 units on a scale
Standard Deviation 0.44
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-1.06 units on a scale
Standard Deviation 0.68
|
|
Change in Clinical Sign Scores
Erythema (Day 18)
|
-1.37 units on a scale
Standard Deviation 0.43
|
-1.20 units on a scale
Standard Deviation 0.62
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-0.35 units on a scale
Standard Deviation 0.41
|
-1.35 units on a scale
Standard Deviation 0.41
|
|
Change in Clinical Sign Scores
Scaling (Day 18)
|
-1.87 units on a scale
Standard Deviation 0.57
|
-1.52 units on a scale
Standard Deviation 0.67
|
-0.67 units on a scale
Standard Deviation 0.44
|
-1.74 units on a scale
Standard Deviation 0.64
|
|
Change in Clinical Sign Scores
Infiltration (Day 18)
|
-1.61 units on a scale
Standard Deviation 0.54
|
-1.11 units on a scale
Standard Deviation 0.62
|
-0.30 units on a scale
Standard Deviation 0.45
|
-1.43 units on a scale
Standard Deviation 0.70
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|
Change in Clinical Sign Scores
Erythema (Day 22)
|
-1.79 units on a scale
Standard Deviation 0.55
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-1.29 units on a scale
Standard Deviation 0.46
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-0.52 units on a scale
Standard Deviation 0.43
|
-1.44 units on a scale
Standard Deviation 0.58
|
|
Change in Clinical Sign Scores
Scaling (Day 22)
|
-2.06 units on a scale
Standard Deviation 0.54
|
-1.73 units on a scale
Standard Deviation 0.64
|
-0.67 units on a scale
Standard Deviation 0.48
|
-1.81 units on a scale
Standard Deviation 0.55
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SECONDARY outcome
Timeframe: Baseline and Days 4, 8, 11, 15, 18, 22, 25Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.
Outcome measures
| Measure |
LEO 90100 Cutaneous Spray, Ointment
n=24 Participants
LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone
n=24 Participants
Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle
n=24 Participants
LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
|
Daivobet® Ointment
n=24 Participants
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
|
|---|---|---|---|---|
|
Changes in Total Clinical Score (TCS) by Visit
Day 11
|
-3.38 Scores on a scale
Standard Deviation 1.17
|
-2.40 Scores on a scale
Standard Deviation 1.38
|
-0.98 Scores on a scale
Standard Deviation 0.87
|
-2.96 Scores on a scale
Standard Deviation 1.41
|
|
Changes in Total Clinical Score (TCS) by Visit
Day 4
|
-0.63 Scores on a scale
Standard Deviation 0.65
|
-0.77 Scores on a scale
Standard Deviation 0.71
|
-0.46 Scores on a scale
Standard Deviation 0.36
|
-0.73 Scores on a scale
Standard Deviation 0.71
|
|
Changes in Total Clinical Score (TCS) by Visit
Day 8
|
-2.08 Scores on a scale
Standard Deviation 1.17
|
-1.83 Scores on a scale
Standard Deviation 1.03
|
-0.42 Scores on a scale
Standard Deviation 0.83
|
-1.96 Scores on a scale
Standard Deviation 1.28
|
|
Changes in Total Clinical Score (TCS) by Visit
Day 15
|
-4.25 Scores on a scale
Standard Deviation 1.07
|
-3.31 Scores on a scale
Standard Deviation 1.31
|
-1.02 Scores on a scale
Standard Deviation 0.94
|
-3.50 Scores on a scale
Standard Deviation 1.54
|
|
Changes in Total Clinical Score (TCS) by Visit
Day 18
|
-4.85 Scores on a scale
Standard Deviation 1.17
|
-3.83 Scores on a scale
Standard Deviation 1.66
|
-1.33 Scores on a scale
Standard Deviation 1.00
|
-4.52 Scores on a scale
Standard Deviation 1.42
|
|
Changes in Total Clinical Score (TCS) by Visit
Day 22
|
-5.71 Scores on a scale
Standard Deviation 1.17
|
-4.38 Scores on a scale
Standard Deviation 1.49
|
-1.56 Scores on a scale
Standard Deviation 1.08
|
-4.75 Scores on a scale
Standard Deviation 1.52
|
|
Changes in Total Clinical Score (TCS) by Visit
Day 25
|
-6.04 Scores on a scale
Standard Deviation 1.15
|
-4.94 Scores on a scale
Standard Deviation 1.68
|
-1.85 Scores on a scale
Standard Deviation 0.88
|
-5.21 Scores on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: Baseline and Day 29Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound
Outcome measures
| Measure |
LEO 90100 Cutaneous Spray, Ointment
n=24 Participants
LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone
n=24 Participants
Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle
n=24 Participants
LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
|
Daivobet® Ointment
n=24 Participants
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
|
|---|---|---|---|---|
|
Change From Baseline in Echo-poor Band Thickness at End of Treatment
|
-0.57 millimetres
Standard Deviation 0.21
|
-0.45 millimetres
Standard Deviation 0.25
|
-0.12 millimetres
Standard Deviation 0.20
|
-0.46 millimetres
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline and Days 8, 15, 22, and 29.Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline
Outcome measures
| Measure |
LEO 90100 Cutaneous Spray, Ointment
n=24 Participants
LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone
n=24 Participants
Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
|
LEO 90100 Cutaneous Spray, Ointment, Vehicle
n=24 Participants
LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
|
Daivobet® Ointment
n=24 Participants
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
|
|---|---|---|---|---|
|
Changes in Total Skin Thickness
Day 29
|
-0.81 millimetres
Standard Deviation 0.41
|
-0.66 millimetres
Standard Deviation 0.42
|
-0.23 millimetres
Standard Deviation 0.30
|
-0.62 millimetres
Standard Deviation 0.37
|
|
Changes in Total Skin Thickness
Day 8
|
-0.37 millimetres
Standard Deviation 0.31
|
-0.28 millimetres
Standard Deviation 0.19
|
-0.07 millimetres
Standard Deviation 0.21
|
-0.33 millimetres
Standard Deviation 0.24
|
|
Changes in Total Skin Thickness
Day 15
|
-0.57 millimetres
Standard Deviation 0.38
|
-0.40 millimetres
Standard Deviation 0.29
|
-0.12 millimetres
Standard Deviation 0.23
|
-0.49 millimetres
Standard Deviation 0.26
|
|
Changes in Total Skin Thickness
Day 22
|
-0.68 millimetres
Standard Deviation 0.40
|
-0.59 millimetres
Standard Deviation 0.35
|
-0.18 millimetres
Standard Deviation 0.25
|
-0.59 millimetres
Standard Deviation 0.33
|
Adverse Events
LEO 90100 Cutaneous Spray, Ointment
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LEO 90100 Cutaneous Spray, Ointment
n=24 participants at risk
Intra-Individual baseline analysis population, all treated with the following four products:
1. LEO 90100 cutaneous spray, ointment: once daily application, 4weeks
2. LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks
3. LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4weeks
4. Daivobet® ointment: once daily application, 4weeks
|
|---|---|
|
Gastrointestinal disorders
Toothache
|
8.3%
2/24 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • Number of events 3
|
|
Nervous system disorders
Headache
|
20.8%
5/24 • Number of events 5
|
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