Trial Outcomes & Findings for A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products (NCT NCT00875277)
NCT ID: NCT00875277
Last Updated: 2025-03-12
Results Overview
The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
COMPLETED
PHASE2
24 participants
From baseline (Day 1) to end of treatment (Day 29)
2025-03-12
Participant Flow
Participants were treated with the investigational medicinal products for 4 weeks followed by a 10-day follow-up period.
Participant milestones
| Measure |
All Randomized Participants
All randomized participants received the six investigational medicinal products on six different test sites. LEO 29102 cream, LEO 29102 plus calcipotriol cream, LEO 29102 plus betamethasone dipropionate cream, Daivobet® ointment, Betamethasone dipropionate cream, and LEO 29102 cream vehicle applied topically once daily six times a week for 4 weeks (not on Sundays) on six different 2-cm diameter site (one per study preparation).
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=24 Participants
All randomized participants received the six products on six different test sites.
|
|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (Day 1) to end of treatment (Day 29)Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
|
-1.60 score on a scale
Standard Deviation 1.18
|
-4.96 score on a scale
Standard Deviation 1.99
|
-3.04 score on a scale
Standard Deviation 1.34
|
-3.96 score on a scale
Standard Deviation 1.49
|
-5.56 score on a scale
Standard Deviation 1.28
|
-6.10 score on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to end of treatment (Day 29)Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
Erythema
|
-0.42 score on a scale
Standard Deviation 0.48
|
-1.71 score on a scale
Standard Deviation 0.81
|
-0.90 score on a scale
Standard Deviation 0.55
|
-1.19 score on a scale
Standard Deviation 0.70
|
-1.85 score on a scale
Standard Deviation 0.63
|
-1.88 score on a scale
Standard Deviation 0.45
|
|
Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
Infiltration
|
-0.46 score on a scale
Standard Deviation 0.33
|
-1.46 score on a scale
Standard Deviation 0.75
|
-0.85 score on a scale
Standard Deviation 0.52
|
-1.17 score on a scale
Standard Deviation 0.50
|
-1.75 score on a scale
Standard Deviation 0.53
|
-2.04 score on a scale
Standard Deviation 0.55
|
|
Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
Scaliness
|
-0.73 score on a scale
Standard Deviation 0.57
|
-1.79 score on a scale
Standard Deviation 0.62
|
-1.29 score on a scale
Standard Deviation 0.51
|
-1.60 score on a scale
Standard Deviation 0.55
|
-1.96 score on a scale
Standard Deviation 0.41
|
-2.19 score on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Change in Erythema Compared to Baseline
Visit 5 (Day 4)
|
-0.04 units on a scale
Standard Deviation 0.25
|
-0.21 units on a scale
Standard Deviation 0.29
|
-0.02 units on a scale
Standard Deviation 0.18
|
-0.08 units on a scale
Standard Deviation 0.24
|
-0.40 units on a scale
Standard Deviation 0.42
|
-0.38 units on a scale
Standard Deviation 0.42
|
|
Change in Erythema Compared to Baseline
Visit 8 (Day 8)
|
-0.08 units on a scale
Standard Deviation 0.38
|
-0.67 units on a scale
Standard Deviation 0.46
|
-0.31 units on a scale
Standard Deviation 0.32
|
-0.29 units on a scale
Standard Deviation 0.29
|
-0.92 units on a scale
Standard Deviation 0.43
|
-0.88 units on a scale
Standard Deviation 0.56
|
|
Change in Erythema Compared to Baseline
Visit 11 (Day 11)
|
-0.23 units on a scale
Standard Deviation 0.33
|
-0.94 units on a scale
Standard Deviation 0.47
|
-0.46 units on a scale
Standard Deviation 0.33
|
-0.44 units on a scale
Standard Deviation 0.37
|
-1.17 units on a scale
Standard Deviation 0.43
|
-1.19 units on a scale
Standard Deviation 0.66
|
|
Change in Erythema Compared to Baseline
Visit 14 (Day 15)
|
-0.40 units on a scale
Standard Deviation 0.36
|
-1.23 units on a scale
Standard Deviation 0.69
|
-0.60 units on a scale
Standard Deviation 0.36
|
-0.77 units on a scale
Standard Deviation 0.42
|
-1.46 units on a scale
Standard Deviation 0.59
|
-1.40 units on a scale
Standard Deviation 0.66
|
|
Change in Erythema Compared to Baseline
Visit 17 (Day 18)
|
-0.44 units on a scale
Standard Deviation 0.40
|
-1.33 units on a scale
Standard Deviation 0.76
|
-0.75 units on a scale
Standard Deviation 0.42
|
-0.98 units on a scale
Standard Deviation 0.40
|
-1.71 units on a scale
Standard Deviation 0.61
|
-1.63 units on a scale
Standard Deviation 0.56
|
|
Change in Erythema Compared to Baseline
Visit 20 (Day 22)
|
-0.46 units on a scale
Standard Deviation 0.49
|
-1.48 units on a scale
Standard Deviation 0.80
|
-0.83 units on a scale
Standard Deviation 0.55
|
-1.04 units on a scale
Standard Deviation 0.51
|
-1.75 units on a scale
Standard Deviation 0.66
|
-1.85 units on a scale
Standard Deviation 0.60
|
|
Change in Erythema Compared to Baseline
Visit 23 (Day 25)
|
-0.42 units on a scale
Standard Deviation 0.43
|
-1.54 units on a scale
Standard Deviation 0.81
|
-0.85 units on a scale
Standard Deviation 0.54
|
-1.08 units on a scale
Standard Deviation 0.50
|
-1.83 units on a scale
Standard Deviation 0.72
|
-1.94 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Change in Scaling Compared to Baseline
Visit 5 (Day 4)
|
-0.17 units on a scale
Standard Deviation 0.35
|
-0.31 units on a scale
Standard Deviation 0.41
|
-0.13 units on a scale
Standard Deviation 0.30
|
-0.21 units on a scale
Standard Deviation 0.41
|
-0.33 units on a scale
Standard Deviation 0.43
|
-0.52 units on a scale
Standard Deviation 0.38
|
|
Change in Scaling Compared to Baseline
Visit 8 (Day 8)
|
-0.27 units on a scale
Standard Deviation 0.42
|
-0.88 units on a scale
Standard Deviation 0.61
|
-0.44 units on a scale
Standard Deviation 0.58
|
-0.63 units on a scale
Standard Deviation 0.58
|
-1.17 units on a scale
Standard Deviation 0.67
|
-1.19 units on a scale
Standard Deviation 0.48
|
|
Change in Scaling Compared to Baseline
Visit 11 (Day 11)
|
-0.40 units on a scale
Standard Deviation 0.33
|
-1.15 units on a scale
Standard Deviation 0.54
|
-0.63 units on a scale
Standard Deviation 0.42
|
-0.71 units on a scale
Standard Deviation 0.61
|
-1.48 units on a scale
Standard Deviation 0.58
|
-1.92 units on a scale
Standard Deviation 0.55
|
|
Change in Scaling Compared to Baseline
Visit 14 (Day 15)
|
-0.52 units on a scale
Standard Deviation 0.52
|
-1.33 units on a scale
Standard Deviation 0.64
|
-0.73 units on a scale
Standard Deviation 0.47
|
-1.00 units on a scale
Standard Deviation 0.55
|
-1.67 units on a scale
Standard Deviation 0.58
|
-2.04 units on a scale
Standard Deviation 0.49
|
|
Change in Scaling Compared to Baseline
Visit 17 (Day 18)
|
-0.65 units on a scale
Standard Deviation 0.45
|
-1.56 units on a scale
Standard Deviation 0.60
|
-0.90 units on a scale
Standard Deviation 0.47
|
-1.15 units on a scale
Standard Deviation 0.54
|
-1.83 units on a scale
Standard Deviation 0.58
|
-2.13 units on a scale
Standard Deviation 0.49
|
|
Change in Scaling Compared to Baseline
Visit 20 (Day 22)
|
-0.54 units on a scale
Standard Deviation 0.29
|
-1.54 units on a scale
Standard Deviation 0.62
|
-0.81 units on a scale
Standard Deviation 0.44
|
-1.27 units on a scale
Standard Deviation 0.42
|
-1.75 units on a scale
Standard Deviation 0.53
|
-2.19 units on a scale
Standard Deviation 0.38
|
|
Change in Scaling Compared to Baseline
Visit 23 (Day 25)
|
-0.75 units on a scale
Standard Deviation 0.42
|
-1.81 units on a scale
Standard Deviation 0.60
|
-1.17 units on a scale
Standard Deviation 0.55
|
-1.46 units on a scale
Standard Deviation 0.57
|
-2.00 units on a scale
Standard Deviation 0.42
|
-2.21 units on a scale
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25Population: The 24 participants that were randomized received all products distributed on six different test sites on the body.
The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale. The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Change in Infiltration Compared to Baseline
Visit 5 (Day 4)
|
-0.06 units on a scale
Standard Deviation 0.27
|
-0.10 units on a scale
Standard Deviation 0.29
|
-0.04 units on a scale
Standard Deviation 0.20
|
0.00 units on a scale
Standard Deviation 0.21
|
-0.27 units on a scale
Standard Deviation 0.25
|
-0.29 units on a scale
Standard Deviation 0.33
|
|
Change in Infiltration Compared to Baseline
Visit 8 (Day 8)
|
-0.06 units on a scale
Standard Deviation 0.31
|
-0.38 units on a scale
Standard Deviation 0.34
|
-0.13 units on a scale
Standard Deviation 0.34
|
-0.29 units on a scale
Standard Deviation 0.51
|
-0.73 units on a scale
Standard Deviation 0.47
|
-0.79 units on a scale
Standard Deviation 0.44
|
|
Change in Infiltration Compared to Baseline
Visit 11 (Day 11)
|
-0.13 units on a scale
Standard Deviation 0.37
|
-0.77 units on a scale
Standard Deviation 0.51
|
-0.31 units on a scale
Standard Deviation 0.38
|
-0.46 units on a scale
Standard Deviation 0.39
|
-1.06 units on a scale
Standard Deviation 0.50
|
-1.29 units on a scale
Standard Deviation 0.62
|
|
Change in Infiltration Compared to Baseline
Visit 14 (Day 15)
|
-0.25 units on a scale
Standard Deviation 0.33
|
-0.98 units on a scale
Standard Deviation 0.60
|
-0.42 units on a scale
Standard Deviation 0.43
|
-0.69 units on a scale
Standard Deviation 0.38
|
-1.35 units on a scale
Standard Deviation 0.65
|
-1.79 units on a scale
Standard Deviation 0.59
|
|
Change in Infiltration Compared to Baseline
Visit 17 (Day 18)
|
-0.33 units on a scale
Standard Deviation 0.35
|
-1.10 units on a scale
Standard Deviation 0.61
|
-0.58 units on a scale
Standard Deviation 0.46
|
-0.75 units on a scale
Standard Deviation 0.39
|
-1.50 units on a scale
Standard Deviation 0.63
|
-1.94 units on a scale
Standard Deviation 0.61
|
|
Change in Infiltration Compared to Baseline
Visit 20 (Day 22)
|
-0.31 units on a scale
Standard Deviation 0.29
|
-1.25 units on a scale
Standard Deviation 0.66
|
-0.56 units on a scale
Standard Deviation 0.47
|
-0.90 units on a scale
Standard Deviation 0.33
|
-1.67 units on a scale
Standard Deviation 0.62
|
-1.98 units on a scale
Standard Deviation 0.52
|
|
Change in Infiltration Compared to Baseline
Visit 23 (Day 25)
|
-0.38 units on a scale
Standard Deviation 0.34
|
-1.35 units on a scale
Standard Deviation 0.73
|
-0.73 units on a scale
Standard Deviation 0.47
|
-1.06 units on a scale
Standard Deviation 0.40
|
-1.67 units on a scale
Standard Deviation 0.60
|
-2.02 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Visit 5 (Day 4)
|
-0.27 score on a scale
Standard Deviation 0.66
|
-0.63 score on a scale
Standard Deviation 0.80
|
-0.19 score on a scale
Standard Deviation 0.53
|
-0.29 score on a scale
Standard Deviation 0.66
|
-1.00 score on a scale
Standard Deviation 0.88
|
-1.19 score on a scale
Standard Deviation 0.86
|
|
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Visit 8 (Day 8)
|
-0.42 score on a scale
Standard Deviation 0.78
|
-1.92 score on a scale
Standard Deviation 1.18
|
-0.88 score on a scale
Standard Deviation 0.97
|
-1.21 score on a scale
Standard Deviation 1.07
|
-2.81 score on a scale
Standard Deviation 1.26
|
-2.85 score on a scale
Standard Deviation 1.17
|
|
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Visit 11 (Day 11)
|
-0.75 score on a scale
Standard Deviation 0.75
|
-2.85 score on a scale
Standard Deviation 1.26
|
-1.40 score on a scale
Standard Deviation 0.90
|
-1.60 score on a scale
Standard Deviation 1.11
|
-3.71 score on a scale
Standard Deviation 1.28
|
-4.40 score on a scale
Standard Deviation 1.42
|
|
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Visit 14 (Day 15)
|
-1.17 score on a scale
Standard Deviation 0.89
|
-3.54 score on a scale
Standard Deviation 1.66
|
-1.75 score on a scale
Standard Deviation 1.12
|
-2.46 score on a scale
Standard Deviation 1.00
|
-4.48 score on a scale
Standard Deviation 1.56
|
-5.23 score on a scale
Standard Deviation 1.41
|
|
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Visit 17 (Day 18)
|
-1.42 score on a scale
Standard Deviation 0.95
|
-4.00 score on a scale
Standard Deviation 1.72
|
-2.23 score on a scale
Standard Deviation 1.11
|
-2.88 score on a scale
Standard Deviation 0.99
|
-5.04 score on a scale
Standard Deviation 1.46
|
-5.69 score on a scale
Standard Deviation 1.30
|
|
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Visit 20 (Day 22)
|
-1.31 score on a scale
Standard Deviation 0.83
|
-4.27 score on a scale
Standard Deviation 1.92
|
-2.21 score on a scale
Standard Deviation 1.20
|
-3.21 score on a scale
Standard Deviation 0.98
|
-5.17 score on a scale
Standard Deviation 1.64
|
-6.02 score on a scale
Standard Deviation 1.08
|
|
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Visit 23 (Day 25)
|
-1.54 score on a scale
Standard Deviation 0.97
|
-4.71 score on a scale
Standard Deviation 1.99
|
-2.75 score on a scale
Standard Deviation 1.32
|
-3.60 score on a scale
Standard Deviation 1.25
|
-5.50 score on a scale
Standard Deviation 1.47
|
-6.17 score on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: At Day 8, Day 15, Day 22 and end of treatmentPopulation: The 24 participants that were randomized received all products distributed on six different test sites on the body.
The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment.
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
Visit 8 (Day 8)
|
0.05 mm
Standard Deviation 0.22
|
-0.14 mm
Standard Deviation 0.32
|
0.03 mm
Standard Deviation 0.24
|
0.00 mm
Standard Deviation 0.24
|
-0.30 mm
Standard Deviation 0.27
|
-0.39 mm
Standard Deviation 0.30
|
|
Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
Visit 14 (Day 15)
|
-0.05 mm
Standard Deviation 0.23
|
-0.45 mm
Standard Deviation 0.39
|
-0.16 mm
Standard Deviation 0.31
|
-0.25 mm
Standard Deviation 0.36
|
-0.51 mm
Standard Deviation 0.32
|
-0.68 mm
Standard Deviation 0.46
|
|
Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
Visit 20 (Day 22)
|
-0.07 mm
Standard Deviation 0.27
|
-0.54 mm
Standard Deviation 0.37
|
-0.15 mm
Standard Deviation 0.19
|
-0.24 mm
Standard Deviation 0.32
|
-0.57 mm
Standard Deviation 0.34
|
-0.68 mm
Standard Deviation 0.39
|
|
Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
Visit 26 (Day 29)
|
-0.13 mm
Standard Deviation 0.30
|
-0.63 mm
Standard Deviation 0.39
|
-0.30 mm
Standard Deviation 0.31
|
-0.38 mm
Standard Deviation 0.30
|
-0.68 mm
Standard Deviation 0.34
|
-0.78 mm
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: At end of treatmentPopulation: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. Cells counted per mm\^2 were cells that were positive for the indicated biomarker.
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Biomarkers by Immunochemistry
Macrophages: CD163
|
313.9 cells/mm^2
Standard Deviation 97.28
|
197.4 cells/mm^2
Standard Deviation 69.51
|
291.2 cells/mm^2
Standard Deviation 100.8
|
383.5 cells/mm^2
Standard Deviation 488.6
|
178.2 cells/mm^2
Standard Deviation 27.96
|
172.9 cells/mm^2
Standard Deviation 40.61
|
|
Biomarkers by Immunochemistry
Dendritic cells CD1a
|
233.8 cells/mm^2
Standard Deviation 113.9
|
42.14 cells/mm^2
Standard Deviation 27.81
|
229.3 cells/mm^2
Standard Deviation 134.2
|
244.0 cells/mm^2
Standard Deviation 118.9
|
34.31 cells/mm^2
Standard Deviation 20.00
|
56.34 cells/mm^2
Standard Deviation 33.81
|
|
Biomarkers by Immunochemistry
T-cell biomarker CD3
|
593.8 cells/mm^2
Standard Deviation 243.9
|
124.5 cells/mm^2
Standard Deviation 105.9
|
464.2 cells/mm^2
Standard Deviation 275.9
|
492.7 cells/mm^2
Standard Deviation 280.4
|
126.1 cells/mm^2
Standard Deviation 95.57
|
143.9 cells/mm^2
Standard Deviation 161.5
|
|
Biomarkers by Immunochemistry
Angiogenesis: CD31
|
430.7 cells/mm^2
Standard Deviation 165.7
|
216.3 cells/mm^2
Standard Deviation 100.1
|
331.1 cells/mm^2
Standard Deviation 120.9
|
348.8 cells/mm^2
Standard Deviation 158.1
|
184.2 cells/mm^2
Standard Deviation 38.84
|
186.6 cells/mm^2
Standard Deviation 51.62
|
|
Biomarkers by Immunochemistry
T-cell biomarker: CD4
|
284.3 cells/mm^2
Standard Deviation 123.9
|
59.17 cells/mm^2
Standard Deviation 41.78
|
246.4 cells/mm^2
Standard Deviation 148.0
|
239.0 cells/mm^2
Standard Deviation 147.3
|
55.56 cells/mm^2
Standard Deviation 44.03
|
66.95 cells/mm^2
Standard Deviation 55.07
|
|
Biomarkers by Immunochemistry
T-cell biomarker: CD45RO
|
752.0 cells/mm^2
Standard Deviation 183.1
|
101.6 cells/mm^2
Standard Deviation 78.14
|
630.1 cells/mm^2
Standard Deviation 318.8
|
643.6 cells/mm^2
Standard Deviation 370.4
|
121.6 cells/mm^2
Standard Deviation 50.39
|
218.2 cells/mm^2
Standard Deviation 258.7
|
|
Biomarkers by Immunochemistry
Macrophages: CD68
|
370.8 cells/mm^2
Standard Deviation 58.56
|
120.3 cells/mm^2
Standard Deviation 61.57
|
323.1 cells/mm^2
Standard Deviation 114.2
|
303.8 cells/mm^2
Standard Deviation 117.8
|
142.1 cells/mm^2
Standard Deviation 58.47
|
156.8 cells/mm^2
Standard Deviation 44.82
|
|
Biomarkers by Immunochemistry
T-cell biomarker: CD8
|
280.5 cells/mm^2
Standard Deviation 156.0
|
60.05 cells/mm^2
Standard Deviation 61.95
|
220.7 cells/mm^2
Standard Deviation 123.9
|
253.2 cells/mm^2
Standard Deviation 171.9
|
66.35 cells/mm^2
Standard Deviation 53.30
|
65.05 cells/mm^2
Standard Deviation 72.00
|
SECONDARY outcome
Timeframe: At end of treatmentPopulation: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Biomarkers by Immunochemistry: Epidermal Differentiation
Epidermal differentiation: CK10
|
0.76 %, positive area/total area
Standard Deviation 0.14
|
0.89 %, positive area/total area
Standard Deviation 0.15
|
0.77 %, positive area/total area
Standard Deviation 0.14
|
0.75 %, positive area/total area
Standard Deviation 0.11
|
0.93 %, positive area/total area
Standard Deviation 0.08
|
0.89 %, positive area/total area
Standard Deviation 0.25
|
|
Biomarkers by Immunochemistry: Epidermal Differentiation
Epidermal differentiation: CK16
|
0.11 %, positive area/total area
Standard Deviation 0.14
|
0.00 %, positive area/total area
Standard Deviation 0.00
|
0.08 %, positive area/total area
Standard Deviation 0.11
|
0.02 %, positive area/total area
Standard Deviation 0.04
|
0.01 %, positive area/total area
Standard Deviation 0.01
|
0.00 %, positive area/total area
Standard Deviation 0.01
|
SECONDARY outcome
Timeframe: At end of treatmentPopulation: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. By measurement of the cell-cycle marker, Ki-67 protein, an evaluation of the degree of skin cell proliferation and thereby epidermal proliferation could be obtained. Cells counted per mm\^2 were cells that were positive for the indicated biomarker.
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=12 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=6 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=18 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=6 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=6 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Biomarkers by Immunochemistry: Epidermal Proliferation
|
554.1 cells/mm^2
Standard Deviation 391.9
|
19.45 cells/mm^2
Standard Deviation 28.69
|
443.3 cells/mm^2
Standard Deviation 298.6
|
354.3 cells/mm^2
Standard Deviation 198.2
|
20.50 cells/mm^2
Standard Deviation 29.11
|
93.49 cells/mm^2
Standard Deviation 134.9
|
SECONDARY outcome
Timeframe: At end of treatmentPopulation: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. The extent of the following parameters were measured in scored semi-quantitatively (semi) on blinded haematoxylin and eosin (HE) sections. Semi-quantitative scoring was categorized as No (0), mild (1), moderate (2), marked (3) or severe (4). In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum) the tissue was classified by the characteristics seen below: * Morphology of epidermis * Stratum corneum (semi (extent of)) * Stratum granulosum (semi (extent of)) * Parakeratosis (semi (extent of)) * Infiltration of inflammatory cells (semi (extent of))
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=24 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=24 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=24 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=24 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=24 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Pathology and Histology by Treatment
Infiltration of inflammatory cells
|
1.50 score on a scale
Standard Deviation 0.80
|
0.17 score on a scale
Standard Deviation 0.41
|
1.52 score on a scale
Standard Deviation 0.79
|
1.53 score on a scale
Standard Deviation 0.94
|
0.50 score on a scale
Standard Deviation 0.55
|
0.67 score on a scale
Standard Deviation 1.03
|
|
Pathology and Histology by Treatment
Parakeratosis
|
1.67 score on a scale
Standard Deviation 1.15
|
0.00 score on a scale
Standard Deviation 0.00
|
1.39 score on a scale
Standard Deviation 1.34
|
1.35 score on a scale
Standard Deviation 1.11
|
0.00 score on a scale
Standard Deviation 0.00
|
0.17 score on a scale
Standard Deviation 0.41
|
|
Pathology and Histology by Treatment
Stratum Corneum
|
1.83 score on a scale
Standard Deviation 0.83
|
0.33 score on a scale
Standard Deviation 0.52
|
1.52 score on a scale
Standard Deviation 0.90
|
1.41 score on a scale
Standard Deviation 0.94
|
0.50 score on a scale
Standard Deviation 0.55
|
0.33 score on a scale
Standard Deviation 0.82
|
|
Pathology and Histology by Treatment
Stratum Granulosum
|
1.42 score on a scale
Standard Deviation 1.24
|
0.17 score on a scale
Standard Deviation 0.41
|
1.04 score on a scale
Standard Deviation 1.26
|
1.00 score on a scale
Standard Deviation 1.17
|
0.00 score on a scale
Standard Deviation 0.00
|
0.17 score on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: At end of treatmentPopulation: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic epidermal thickness. This was measured in the absolute number of µm measured on blinded haematoxylin and eosin (HE) sections..
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=12 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=6 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=24 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=18 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=6 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=6 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Pathology and Histology by Treatment: Epidermal Thickness
|
254.6 µm
Standard Deviation 58.68
|
73.81 µm
Standard Deviation 20.61
|
187.5 µm
Standard Deviation 79.65
|
176.4 µm
Standard Deviation 49.05
|
68.48 µm
Standard Deviation 18.16
|
66.90 µm
Standard Deviation 44.53
|
SECONDARY outcome
Timeframe: At end of treatmentPopulation: Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.
Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic of frequency of neutrophil microabscesses (Monroe´s abscess). This was measured in absolute number of cells that were positive for the marker on blinded haematoxylin and eosin (HE) sections.
Outcome measures
| Measure |
LEO 29102 Cream Vehicle
n=11 Participants
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
|
Betamethasone Dipropionate Cream
n=6 Participants
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
LEO 29102 Cream
n=23 Participants
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Calcipotriol Cream
n=17 Participants
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
|
LEO 29102 Plus Betamethasone Dipropionate
n=6 Participants
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
|
Daivobet® Ointment
n=6 Participants
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses
|
0.14 cells/mm^2
Standard Deviation 0.26
|
0.00 cells/mm^2
Standard Deviation 0.00
|
0.15 cells/mm^2
Standard Deviation 0.35
|
0.17 cells/mm^2
Standard Deviation 0.30
|
0.00 cells/mm^2
Standard Deviation 0.00
|
0.05 cells/mm^2
Standard Deviation 0.13
|
Adverse Events
All Randomized Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Randomized Participants
n=24 participants at risk
All randomized participants received the six products on six different test sites.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
3/24 • From baseline to end of Follow-up (Day 43±2)
|
|
Gastrointestinal disorders
Diverticulitis
|
4.2%
1/24 • From baseline to end of Follow-up (Day 43±2)
|
|
Gastrointestinal disorders
Toothache
|
4.2%
1/24 • From baseline to end of Follow-up (Day 43±2)
|
|
Infections and infestations
Hordeolum
|
4.2%
1/24 • From baseline to end of Follow-up (Day 43±2)
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • From baseline to end of Follow-up (Day 43±2)
|
|
Infections and infestations
Postoperative infection
|
4.2%
1/24 • From baseline to end of Follow-up (Day 43±2)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
4.2%
1/24 • From baseline to end of Follow-up (Day 43±2)
|
|
Nervous system disorders
Headache
|
16.7%
4/24 • From baseline to end of Follow-up (Day 43±2)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • From baseline to end of Follow-up (Day 43±2)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO retains the right to publish the results of this clinical trial.
- Publication restrictions are in place
Restriction type: OTHER