Trial Outcomes & Findings for LEO 90100 in the Treatment of Psoriasis Vulgaris (NCT NCT01536938)

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

303 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-03-07

Participant Flow

First Subject First Visit: 07-MAY-2012 Last Subject Last Visit: 10-OCT-2012

Prior to randomisation, the subjects entered a washout phase (if required) where antipsoriatic treatm. and other relevant medication/treatms. had to be discontin. 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

Participant milestones
Measure	LEO 90100 LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Betamethasone Dipropionate Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Calcipotriol Aerosol Foam Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
Overall Study STARTED	100	101	101
Overall Study COMPLETED	94	94	93
Overall Study NOT COMPLETED	6	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LEO 90100 in the Treatment of Psoriasis Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 90100 n=100 Participants LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Betamethasone Dipropionate n=101 Participants Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Calcipotriol Aerosol Foam n=101 Participants Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks	Total n=302 Participants Total of all reporting groups
Age, Continuous	47.4 years STANDARD_DEVIATION 14.8 • n=5 Participants	49.0 years STANDARD_DEVIATION 14.4 • n=7 Participants	50.7 years STANDARD_DEVIATION 14.7 • n=5 Participants	49.0 years STANDARD_DEVIATION 14.7 • n=4 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	45 Participants n=7 Participants	40 Participants n=5 Participants	132 Participants n=4 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	56 Participants n=7 Participants	61 Participants n=5 Participants	170 Participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	LEO 90100 n=100 Participants LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Betamethasone Dipropionate n=101 Participants Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Calcipotriol Aerosol Foam n=101 Participants Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
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.	45 participants	31 participants	15 participants

Adverse Events

LEO 90100

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Betamethasone Dipropionate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calcipotriol Aerosol Foam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LEO 90100 n=100 participants at risk LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Betamethasone Dipropionate n=99 participants at risk Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Calcipotriol Aerosol Foam n=99 participants at risk LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
Immune system disorders Hypersensitivity	1.0% 1/100 • Number of events 1 A total of 101 patients were randomized to each study arm - "Betamethasone Dipropionate" and "Calcipotriol Aerosol Foam". However, two of the subjects in each arm had not applied any study medication and therefore the safety analysis included only the 99 subjects that used the study medication in the respective arm.	0.00% 0/99 A total of 101 patients were randomized to each study arm - "Betamethasone Dipropionate" and "Calcipotriol Aerosol Foam". However, two of the subjects in each arm had not applied any study medication and therefore the safety analysis included only the 99 subjects that used the study medication in the respective arm.	0.00% 0/99 A total of 101 patients were randomized to each study arm - "Betamethasone Dipropionate" and "Calcipotriol Aerosol Foam". However, two of the subjects in each arm had not applied any study medication and therefore the safety analysis included only the 99 subjects that used the study medication in the respective arm.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 44945888

Email: [email protected]

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