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Trial Outcomes & Findings for LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris (NCT NCT01866163)

NCT ID: NCT01866163

Last Updated: 2025-03-10

Results Overview

Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

426 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-03-10

Participant Flow

First Subject First Visit: 17-Jun-2013 Last Subject Last Visit: 02-Oct-2013

Prior to randomisation, the subject entered a washout phase (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The wash-out/screening phase could last for up to 4 weeks, depending on which disallowed treatments the subject received.

Participant milestones

Participant milestones
Measure
LEO 90100
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Vehicle
Aerosol foam vehicle
Overall Study
STARTED
323
103
Overall Study
COMPLETED
313
99
Overall Study
NOT COMPLETED
10
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
LEO 90100
n=323 Participants
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Vehicle
n=103 Participants
Aerosol foam vehicle
Total
n=426 Participants
Total of all reporting groups
Age, Continuous
51.2 years
STANDARD_DEVIATION 13.9 • n=5 Participants
46.0 years
STANDARD_DEVIATION 13.2 • n=7 Participants
50.0 years
STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male
Female
119 Participants
n=5 Participants
54 Participants
n=7 Participants
173 Participants
n=5 Participants
Sex: Female, Male
Male
204 Participants
n=5 Participants
49 Participants
n=7 Participants
253 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: All randomised subjects were included in the full analysis set and analysed for efficacy.

Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe

Outcome measures

Outcome measures
Measure
LEO 90100
n=323 Participants
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Vehicle
n=103 Participants
Aerosol foam vehicle
Treatment Success According to IGA
53.3 percentage of subjects
4.8 percentage of subjects

SECONDARY outcome

Timeframe: 4 weeks

Population: All randomised subjects were included in the full analysis set and analysed for efficacy.

The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst).

Outcome measures

Outcome measures
Measure
LEO 90100
n=323 Participants
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Vehicle
n=103 Participants
Aerosol foam vehicle
m-PASI at Week 4
2.04 Scores on a scale
Interval 1.74 to 2.35
5.33 Scores on a scale
Interval 4.79 to 5.86

SECONDARY outcome

Timeframe: 1 week

Population: All randomised subjects were included in the full analysis set and analysed for efficacy.

The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst).

Outcome measures

Outcome measures
Measure
LEO 90100
n=323 Participants
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Vehicle
n=103 Participants
Aerosol foam vehicle
m-PASI at Week 1
4.66 Scores on a scale
Interval 4.41 to 4.9
5.93 Scores on a scale
Interval 5.5 to 6.36

Adverse Events

LEO 90100

Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths

Vehicle

Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
LEO 90100
n=323 participants at risk
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Vehicle
n=103 participants at risk
Aerosol foam vehicle
Psychiatric disorders
Substance induced psychotic disorder
0.31%
1/323 • Number of events 1
0.00%
0/103
Psychiatric disorders
Bipolar disorder
0.31%
1/323 • Number of events 1
0.00%
0/103

Other adverse events

Other adverse events
Measure
LEO 90100
n=323 participants at risk
LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Vehicle
n=103 participants at risk
Aerosol foam vehicle
Infections and infestations
Nasopharyngitis
1.9%
6/323 • Number of events 6
0.00%
0/103
General disorders
Application site pain
0.93%
3/323 • Number of events 4
1.9%
2/103 • Number of events 2
Gastrointestinal disorders
Diarrhoea
0.62%
2/323 • Number of events 2
0.97%
1/103 • Number of events 1
Gastrointestinal disorders
Nausea
0.62%
2/323 • Number of events 2
0.00%
0/103
Musculoskeletal and connective tissue disorders
Flank pain
0.62%
2/323 • Number of events 2
0.00%
0/103
Investigations
Blood pressure increased
0.93%
3/323 • Number of events 4
0.00%
0/103
Infections and infestations
Eye infection
0.00%
0/323
0.97%
1/103 • Number of events 1
Infections and infestations
Gastroenteritis viral
0.00%
0/323
0.97%
1/103 • Number of events 1
Infections and infestations
Streptococcal infection
0.00%
0/323
0.97%
1/103 • Number of events 1
General disorders
Application site dryness
0.00%
0/323
0.97%
1/103 • Number of events 1
General disorders
Application site erosion
0.00%
0/323
0.97%
1/103 • Number of events 1
General disorders
Application site erythema
0.00%
0/323
0.97%
1/103 • Number of events 1
General disorders
Application site oedema
0.00%
0/323
0.97%
1/103 • Number of events 1
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/323
0.97%
1/103 • Number of events 1
Injury, poisoning and procedural complications
Sunburn
0.00%
0/323
0.97%
1/103 • Number of events 1
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/323
0.97%
1/103 • Number of events 1
Skin and subcutaneous tissue disorders
Angioedema
0.00%
0/323
0.97%
1/103 • Number of events 1
Nervous system disorders
Dizziness
0.00%
0/323
0.97%
1/103 • Number of events 1

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 44945888

Results disclosure agreements

  • Principal investigator is a sponsor employee LEO acknowledges the investigators' right to publish the results of the trial, irrespective of outcome. Pubs/presentations by investigator(s) shall not be made before the results of a joint publication is public. 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