Trial Outcomes & Findings for A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris (NCT NCT02518048)
NCT ID: NCT02518048
Last Updated: 2025-03-10
Results Overview
The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe). The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site. Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT). The mean TCS at Baseline was 6.6 for both groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Day 1 (Baseline) to Day 29
Results posted on
2025-03-10
Participant Flow
Participant milestones
| Measure |
LEO 90100 Aerosol Foam; Betesil® 2.25 mg
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
LEO 90100 Aerosol Foam; Betesil® 2.25 mg
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
All Study Participants
n=35 Participants
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) to Day 29The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe). The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site. Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT). The mean TCS at Baseline was 6.6 for both groups.
Outcome measures
| Measure |
LEO 90100 Aerosol Foam
n=35 Participants
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
|
Betesil® 2.25 mg
n=35 Participants
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg
|
|---|---|---|
|
Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline
TCS at Baseline
|
6.6 units on a scale
Standard Deviation 0.6
|
6.6 units on a scale
Standard Deviation 0.6
|
|
Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline
Change in TCS Baseline to EoT
|
-5.8 units on a scale
Standard Deviation 1.1
|
-3.6 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 29Outcome measures
| Measure |
LEO 90100 Aerosol Foam
n=35 Participants
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
|
Betesil® 2.25 mg
n=35 Participants
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg
|
|---|---|---|
|
Change in TCS at Individual Visits
Day 4/Visit 5
|
-1.3 units on a scale
Standard Deviation 0.8
|
-1.3 units on a scale
Standard Deviation 0.7
|
|
Change in TCS at Individual Visits
Day 8/Visit 8
|
-3.2 units on a scale
Standard Deviation 1.2
|
-2.0 units on a scale
Standard Deviation 1.1
|
|
Change in TCS at Individual Visits
Day 11/Visit 11
|
-4.3 units on a scale
Standard Deviation 1.1
|
-2.4 units on a scale
Standard Deviation 1.4
|
|
Change in TCS at Individual Visits
Day 15/Visit 15
|
-4.8 units on a scale
Standard Deviation 1.2
|
-2.8 units on a scale
Standard Deviation 1.4
|
|
Change in TCS at Individual Visits
Day 18/Visit 18
|
-5.1 units on a scale
Standard Deviation 1.2
|
-3.1 units on a scale
Standard Deviation 1.5
|
|
Change in TCS at Individual Visits
Day 22/Visit 20
|
-5.5 units on a scale
Standard Deviation 1.2
|
-3.2 units on a scale
Standard Deviation 1.6
|
|
Change in TCS at Individual Visits
Day 25/Visit 23
|
-5.7 units on a scale
Standard Deviation 1.1
|
-3.6 units on a scale
Standard Deviation 1.6
|
|
Change in TCS at Individual Visits
Day 29/Visit 26
|
-5.9 units on a scale
Standard Deviation 1.1
|
-3.7 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 29The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe). Erythema: 0 (no evidence - normal skin color) to 3 (severe - intense red). Scaling: 0 (no evidence - no scaling) to 3 (severe - coarse, thick scales). Infiltration: 0 (no evidence - no infiltration) to 3 (severe - very marked infiltration).
Outcome measures
| Measure |
LEO 90100 Aerosol Foam
n=35 Participants
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
|
Betesil® 2.25 mg
n=35 Participants
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg
|
|---|---|---|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Erythema Day 4/Visit 5
|
-0.5 units on a scale
Standard Deviation 0.4
|
-0.4 units on a scale
Standard Deviation 0.4
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Erythema Day 8/Visit 8
|
-0.9 units on a scale
Standard Deviation 0.4
|
-0.6 units on a scale
Standard Deviation 0.4
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Erythema Day 11/Visit 11
|
-1.3 units on a scale
Standard Deviation 0.5
|
-0.8 units on a scale
Standard Deviation 0.5
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Erythema Day 15/Visit 14
|
-1.4 units on a scale
Standard Deviation 0.5
|
-0.9 units on a scale
Standard Deviation 0.5
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Erythema Day 18/Visit 17
|
-1.6 units on a scale
Standard Deviation 0.6
|
-1.0 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Erythema Day 22/Visit 20
|
-1.7 units on a scale
Standard Deviation 0.6
|
-1.1 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Erythema Day 25/Visit 23
|
-1.8 units on a scale
Standard Deviation 0.6
|
-1.3 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Erythema Day 29/Visit 26
|
-1.9 units on a scale
Standard Deviation 0.5
|
-1.2 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Scaling Day 4/Visit 5
|
-0.6 units on a scale
Standard Deviation 0.3
|
-0.6 units on a scale
Standard Deviation 0.3
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Scaling Day 8/Visit 8
|
-1.3 units on a scale
Standard Deviation 0.5
|
-0.8 units on a scale
Standard Deviation 0.5
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Scaling Day 11/Visit 11
|
-1.7 units on a scale
Standard Deviation 0.5
|
-1.0 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Scaling Day 15/Visit 14
|
-1.8 units on a scale
Standard Deviation 0.5
|
-1.1 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Scaling Day 18/Visit 17
|
-1.9 units on a scale
Standard Deviation 0.5
|
-1.2 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Scaling Day 22/Visit 20
|
-2.0 units on a scale
Standard Deviation 0.5
|
-1.2 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Scaling Day 25/Visit 23
|
-2.0 units on a scale
Standard Deviation 0.4
|
-1.4 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Scaling Day 29/Visit 26
|
-2.0 units on a scale
Standard Deviation 0.4
|
-1.3 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Infiltration Day 4/Visit 5
|
-0.3 units on a scale
Standard Deviation 0.2
|
-0.3 units on a scale
Standard Deviation 0.2
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Infiltration Day 8/Visit 8
|
-0.9 units on a scale
Standard Deviation 0.5
|
-0.5 units on a scale
Standard Deviation 0.4
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Infiltration Day 11/Visit 11
|
-1.3 units on a scale
Standard Deviation 0.4
|
-0.6 units on a scale
Standard Deviation 0.5
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Infiltration Day 15/Visit 14
|
-1.6 units on a scale
Standard Deviation 0.4
|
-0.8 units on a scale
Standard Deviation 0.5
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Infiltration Day 18/Visit 17
|
-1.7 units on a scale
Standard Deviation 0.4
|
-0.8 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Infiltration Day 22/Visit 20
|
-1.8 units on a scale
Standard Deviation 0.3
|
-0.9 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Infiltration Day 25/Visit 23
|
-1.9 units on a scale
Standard Deviation 0.3
|
-1.0 units on a scale
Standard Deviation 0.6
|
|
Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
Infiltration Day 29/Visit 26
|
-1.9 units on a scale
Standard Deviation 0.3
|
-1.1 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline to End of TreatmentSkin thickness ultrasound measurements of the test sites were performed at Baseline and End of Treatment. Two skin parameters were calculated using ultrasound: * The mean total skin thickness * The mean echo-poor band thickness
Outcome measures
| Measure |
LEO 90100 Aerosol Foam
n=35 Participants
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)
LEO 90100 Aerosol foam
|
Betesil® 2.25 mg
n=35 Participants
Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)
Betesil® 2.25 mg
|
|---|---|---|
|
Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT
Change in Total Skin Thickness
|
-1.0 millimeters
Standard Deviation 0.3
|
-0.6 millimeters
Standard Deviation 0.4
|
|
Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT
Change in Echo-Poor Band Thickness
|
-1.3 millimeters
Standard Deviation 0.5
|
-0.7 millimeters
Standard Deviation 0.5
|
Adverse Events
All Subjects
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=35 participants at risk
All subjects received both medication and reporting is on the entire population.
|
|---|---|
|
Nervous system disorders
Headache
|
14.3%
5/35 • Number of events 8 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
|
Infections and infestations
Influenza
|
8.6%
3/35 • Number of events 3 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
|
Infections and infestations
Hordeolum
|
2.9%
1/35 • Number of events 1 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.6%
3/35 • Number of events 3 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.9%
1/35 • Number of events 1 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • Number of events 1 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • Number of events 1 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
1/35 • Number of events 1 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
|
General disorders
Pyrexia
|
2.9%
1/35 • Number of events 1 • From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Before submitting or presenting a manuscript about the clinical trial to a third party, the investigator shall give LEO a copy of any such manuscript, and LEO has the right to review and comment. Upon the request of LEO, the investigator shall remove any confidential information before submitting or presenting a manuscript. To allow LEO to protect its inventions and other intellectual property rights, the publication or presentation can be delayed.
- Publication restrictions are in place
Restriction type: OTHER