LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

• Sponsor: LEO Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02899962
• Collaborator: (none)
• Enrollment: 722
• Locations: 58
• Arms: 2
• Actual Duration (Months): 28.3
• Patients Per Site: 12.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris.

A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: LEO 90100 aerosol foam; Drug: LEO 90100 aerosol foam vehicle	Phase 3

Detailed Description

After an initial 4-week period of once-daily treatment with open-label active LEO 90100 aerosol foam, subjects who qualify for randomisation will continue into a 52-week maintenance treatment period with twice-weekly application of randomised LEO 90100 aerosol foam / LEO 90100 aerosol foam vehicle.

If the subject experiences a relapse of psoriasis, the active lesions will be treated for 4 weeks with open-label active LEO 90100 aerosol foam.

Study Design

• Study Type: Interventional
• Actual Enrollment: 722 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
• Actual Study Start Date: Feb 15, 2017
• Actual Primary Completion Date: Jun 26, 2019
• Actual Study Completion Date: Jun 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LEO 90100 aerosol foam Topical application twice weekly for 52 weeks	Drug: LEO 90100 aerosol foam; LEO 90100 aerosol foam twice weekly
Placebo Comparator: LEO 90100 aerosol foam vehicle Topical application twice weekly for 52 weeks	Drug: LEO 90100 aerosol foam vehicle; LEO 90100 aerosol foam vehicle twice weekly

Outcome Measures

Primary Outcome Measures

1. Time to First Relapse [From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)]

   Time to first relapse (at least 'mild' according to the Physician's Global Assessment of disease severity [PGA]). The investigator was to grade the severity of psoriasis of the trunk and limbs using Physician's global assessment of disease severity 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4

Secondary Outcome Measures

1. Proportion of Days in Remission During the Maintenance Phase [From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)]

   Remission defined as 'clear' or 'almost clear' according to the PGA. The investigator was to grade using a global assessment of the disease severity of psoriasis of the trunk and limbs using the PGA 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4

2. Number of Relapses During the Maintenance Phase [From Randomisation (Week 4) until End of Treatment (Week 56)]

   Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA:

• A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs, amenable to treatment with maximum of 100 g of trial medication per week

• Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the body surface area (BSA)

• A target lesion/target location of at least 3 cm at its longest axis located on the body (i.e., not on the scalp, face or intertriginous areas), scoring at least 1 ('mild') for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion/Location

For subjects participating in hypothalamic-pituitary-adrenal (HPA)-axis testing, furthermore:

• An extent of psoriasis vulgaris on trunk and/or limbs of disease severity (PGA) of at least 'moderate' affecting between 10 and 30% of the body surface area (BSA) excluding psoriatic lesions of genitals and skin folds at Visit 1.

EXCLUSION CRITERIA:

• Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1:

• etanercept - within 4 weeks prior to Visit 1

• adalimumab, infliximab - within 8 weeks prior to Visit 1

• ustekinumab - within 16 weeks prior to Visit 1

• secukinumab - within 12 weeks prior to Visit 1

• other products - within 4 weeks/5 half-lives prior to Visit 1 (whichever is longer)

• Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to Visit 1

• Systemic treatment with apremilast within 4 weeks prior to Visit 1

• Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to Visit 1

• Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1

• Severe and/or extensive scalp psoriasis which, in the opinion of the investigator, requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial

For subjects participating in HPA-axis testing, furthermore:

• Antidepressive medications within 4 weeks prior to Visit 1 or during the trial. Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Dermatology Clinical Research	Fremont	California	United States	94538
2	Clinical Science Institute	Santa Monica	California	United States	90404
3	Colorado Medical Research Center	Denver	Colorado	United States	80210
4	International Dermatology Research	Miami	Florida	United States	33144
5	Arlington Dermatology	Arlington Heights	Illinois	United States	60005
6	Derm Research	Louisville	Kentucky	United States	40217
7	DermAssociates	Rockville	Maryland	United States	20850
8	Clarkston Skin Research	Clarkston	Michigan	United States	48346
9	Henry Ford Medical Center - New Center One	Detroit	Michigan	United States	48202
10	Beyer Research	Kalamazoo	Michigan	United States	49009
11	Psoriasis Treatment Center of Central NJ	East Windsor	New Jersey	United States	08520
12	Mount Sinai School of Medicine	New York	New York	United States	10029
13	Sadick Research Group	New York	New York	United States	10075
14	Skin Search of Rochester	Rochester	New York	United States	14623
15	UPMC Department of Dermatology	Pittsburgh	Pennsylvania	United States	15213
16	Rivergate Dermatology Clinical Research Center	Goodlettsville	Tennessee	United States	37072
17	The Skin Wellness Center	Knoxville	Tennessee	United States	37922
18	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
19	Clinical Trials of Texas	San Antonio	Texas	United States	78229
20	Center for Clinical Studies	Webster	Texas	United States	77598
21	Premier Clinical Research	Spokane	Washington	United States	99202
22	Dr. Chih-ho Hong Medical	Surrey	British Columbia	Canada	V3R 6A7
23	Pacific Dermaesthetics	Vancouver	British Columbia	Canada	V6E 4M3
24	Wiseman Dermatology Research	Winnipeg	Manitoba	Canada	R3M 3Z4
25	Maritime Medical Research Centre	Bathurst	New Brunswick	Canada	E2A 4Z9
26	Brunwick Dermatology Center	Fredericton	New Brunswick	Canada	E3B 1G9
27	CCA Medical Research	Ajax	Ontario	Canada	L1S 7K8
28	Dermatrials Research Incorporated	Hamilton	Ontario	Canada	L8N 1V6
29	The Guenther Dermatology Research Centre	London	Ontario	Canada	N6A 3B4
30	Lynderm Research	Markham	Ontario	Canada	L3P 1X2
31	SKiN Center for Dermatology	Peterborough	Ontario	Canada	K9J 5K2
32	K. Papp Clinical Research	Waterloo	Ontario	Canada	N2J 1C4
33	Clinique du Dre Isabelle Delorme Inc	Quebec City	Quebec	Canada	J2B 5L4
34	C.H.U. de Saint-Etienne Service de Dermatologie	Saint Etienne	Saint-Etienne	France	42055
35	CHRU de Brest - Hôpital Morvan	Brest		France	29609
36	C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie	Nice		France	06202
37	CHU de Rennes - Hôpital Pontchaillou	Rennes		France	35033
38	Centre Hospitalier de Valence	Valence		France	26000
39	Klinik und Poliklinik für Dermatologie	Dresden		Germany	01307
40	Universitätsklinikum Erlangen	Erlangen		Germany	91054
41	Universitätsklinikum Essen (AöR), Klinik für Dermatologie	Essen		Germany	54122
42	SRH Wald-Klinikum Gera	Gera		Germany	07548
43	SCIderm GmbH	Hamburg		Germany	20354
44	UKSH - Campus Lübeck	Lubeck		Germany	23538
45	Michael Sebastian	Mahlow		Germany	15831
46	LMU Poliklinik Derma & Allergo	Munchen		Germany	80337
47	Gemein. Weber & Crainic	Schweinfurt		Germany	97421
48	Małopolskie Centrum Kliniczne	Kraków		Poland	31-123
49	NZOZ Med-laser	Lublin		Poland	20-079
50	Solumed	Poznań		Poland	60-425
51	Kliniczny Szpital Wojewódzki, Klinika Dermatologii	Rzeszów		Poland	35-030
52	Wansford and Kings Cliffe Prac	Wansford	Cambridgeshire	United Kingdom	PE8 6PL
53	Ashgate Medical Practice	Chesterfield	Derbyshire	United Kingdom	S40 4AA
54	Burbage Surgery	Burbage	Leicstershire	United Kingdom	LE10 2SE
55	Albany House Medical Centre	Wellingborough	Northamptonshire	United Kingdom	NN8 4RW
56	Sherbourne Medical Centre	Leamington Spa	Warwickshire	United Kingdom	CV32 4RA
57	Chapel Allerton Hospital	Leeds	West Yorkshire	United Kingdom	LS7 4SA
58	Dermatopharmacology Department	Salford		United Kingdom	M6 8HD

Sponsors and Collaborators

• LEO Pharma

Investigators

• Principal Investigator: Mark Lebwohl, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol - Apr 12, 2018
• Statistical Analysis Plan - Jul 15, 2019

More Information

Publications

None provided.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT02899962
• Other Study ID Numbers: LP0053-1004
• First Posted: Sep 14, 2016
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Pre-assignment Detail	722 subjects were screened of which 650 subjects were assigned to treatment with LEO 90100 open-label phase. Subjects did not progress from screening due to adverse event=1, lost to follow-up=2, other reasons=2, screening failures=52, and withdrawal by subject=15. All 650 subjects were exposed to LEO 90100 during the open-label phase

Arm/Group Title	Open-label LEO 90100	Maintenance LEO 90100	Maintenance Vehicle
Arm/Group Description	In the open-label phase, LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily on the body for 4 weeks.	In the maintenance phase, subjects from open-label phase who achieved treatment success according to Physician's Global Assessment of disease severity (clear or almost clear with 2-step improvement) were randomised to receive LEO 90100 twice weekly for 52 weeks. In case of relapse (psoriasis which was mild, moderate or severe according to PGA), rescue medication was applied. Rescue medication was LEO 90100 applied once daily on the body for 4 weeks.	In the maintenance phase, subjects from open-label phase who achieved treatment success according to Physician's Global Assessment of disease severity (clear or almost clear with 2-step improvement) were randomised to receive vehicle twice weekly for 52 weeks. In case of relapse (psoriasis which was mild, moderate or severe according to PGA), rescue medication was applied. Rescue medication was LEO 90100 applied once daily on the body for 4 weeks.
Period Title: Open-label Phase
STARTED	650	0	0
COMPLETED	623	0	0
NOT COMPLETED	27	0	0
Period Title: Open-label Phase
STARTED	0	272	273
COMPLETED	0	131	120
NOT COMPLETED	0	141	153

Baseline Characteristics

Arm/Group Title	LEO 90100 Open-label Phase
Arm/Group Description	LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily on the body for 4 weeks.
Overall Participants	650
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	51.8 (14.2)
Sex: Female, Male (Count of Participants)
Female	226 34.8%
Male	424 65.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	75 11.5%
Not Hispanic or Latino	568 87.4%
Unknown or Not Reported	7 1.1%
Race/Ethnicity, Customized (Count of Participants)
White	584 89.8%
Asian	37 5.7%
Black or African American	9 1.4%
Native Hawaiian or Other Pacific Islander	4 0.6%
American Indian or Alaska Native	1 0.2%
Region of Enrollment (participants) [Number]
Canada	163 25.1%
United States	228 35.1%
Poland	60 9.2%
United Kingdom	79 12.2%
France	61 9.4%
Germany	59 9.1%
PGA (Count of Participants)
Mild	83 12.8%
Moderate	509 78.3%
Severe	58 8.9%

Outcome Measures

1. Primary Outcome

Title	Time to First Relapse
Description	Time to first relapse (at least 'mild' according to the Physician's Global Assessment of disease severity [PGA]). The investigator was to grade the severity of psoriasis of the trunk and limbs using Physician's global assessment of disease severity 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4
Time Frame	From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)

Outcome Measure Data

Analysis Population Description

Full analysis set: included all subjects randomised who had treatment success at randomisation, defined as PGA score of 'clear' or 'almost clear' with at least a 2-grade improvement from baseline

Arm/Group Title	LEO 90100 Aerosol Foam	LEO 90100 Aerosol Foam Vehicle
Arm/Group Description	Topical application of LEO 90100 aerosol foam twice weekly for 52 weeks	Topical application of LEO 90100 aerosol foam vehicle twice weekly for 52 weeks
Measure Participants	256	265
Median (95% Confidence Interval) [days]	56	30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LEO 90100 Aerosol Foam, LEO 90100 Aerosol Foam Vehicle
	Comments	All randomized subjects were considered for statistical analysis.
	Type of Statistical Test	Superiority
	Comments	The primary endpoint was time to first relapse during the maintenance phase. This was calculated as the number of days from randomisation to the day where the subject had the first relapse confirmed. For subjects who either did not encounter a relapse or were withdrawn from the trial, the number of days was treated as a censored observation at the day of end of trial visit.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95%; 0.47 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimates are obtained from a proportional hazards model with treatment group,pooled trial site,disease severity at maintenance baseline (Week 4; determined by PGA) as factors.

2. Secondary Outcome

Title	Proportion of Days in Remission During the Maintenance Phase
Description	Remission defined as 'clear' or 'almost clear' according to the PGA. The investigator was to grade using a global assessment of the disease severity of psoriasis of the trunk and limbs using the PGA 5-point scale: Clear = 0; Almost clear = 1; Mild = 2; Moderate = 3; Severe = 4
Time Frame	From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LEO 90100 Aerosol Foam	LEO 90100 Aerosol Foam Vehicle
Arm/Group Description	Topical application of LEO 90100 aerosol foam twice weekly for 52 weeks	Topical application of LEO 90100 aerosol foam vehicle twice weekly for 52 weeks
Measure Participants	256	265
Mean (Standard Deviation) [Proportion of days]	70.2 (21.7)	60.8 (20.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LEO 90100 Aerosol Foam, LEO 90100 Aerosol Foam Vehicle
	Comments	The number of days in remission was calculated as the sum of days where the subject was in remission periods. The proportion of days in remission was calculated as the number of days in remission divided by the length of the maintenance phase in days.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	Factors adjusted for in the ANOVA model were treatment group, pooled trial site, and disease severity at maintenance baseline (PGA).
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Multiple imputation of data for withdrawn subjects was done using 100 imputations and depended on whether the subject's reason for withdrawal potentially was related to treatment. Length of the maintenance phase was assumed to be 52 weeks (364 days)

3. Secondary Outcome

Title	Number of Relapses During the Maintenance Phase
Description	Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product
Time Frame	From Randomisation (Week 4) until End of Treatment (Week 56)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LEO 90100 Aerosol Foam	LEO 90100 Aerosol Foam Vehicle
Arm/Group Description	Topical application of LEO 90100 aerosol foam twice weekly for 52 weeks	Topical application of LEO 90100 aerosol foam vehicle twice weekly for 52 weeks
Measure Participants	256	265
Mean (Standard Deviation) [relapses]	2.0 (1.7)	3.1 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LEO 90100 Aerosol Foam, LEO 90100 Aerosol Foam Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Poisson regression
	Comments
Method of Estimation	Estimation Parameter	Rate ratio
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95%; 0.46 to 0.63
	Parameter Dispersion	Type: Value:
	Estimation Comments	The number of relapses was analysed using a Poisson regression model with treatment group,pooled sites,disease severity at maintenance baseline as factors, subject as random effect, and time at risk as an offset.

Adverse Events

Time Frame	4 weeks during the open-label phase and 52 weeks during the maintenance phase and 8 weeks during the safety follow-up
Adverse Event Reporting Description	All adverse events were reported by the subjects or observed by the investigators were recorded
Arm/Group Title	LEO 90100 Aerosol Foam Open-label		LEO 90100 Aerosol Foam		LEO 90100 Aerosol Foam Vehicle
Arm/Group Description	Topical application once daily for 4 weeks LEO 90100 aerosol foam open-label		Topical application twice weekly for 52 weeks LEO 90100 aerosol foam: LEO 90100 aerosol foam twice weekly		Topical application twice weekly for 52 weeks LEO 90100 aerosol foam vehicle: LEO 90100 aerosol foam vehicle twice weekly
All Cause Mortality
	LEO 90100 Aerosol Foam Open-label		LEO 90100 Aerosol Foam		LEO 90100 Aerosol Foam Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/650 (0%)		0/272 (0%)		1/273 (0.4%)
Serious Adverse Events
	LEO 90100 Aerosol Foam Open-label		LEO 90100 Aerosol Foam		LEO 90100 Aerosol Foam Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/650 (0.6%)		14/272 (5.1%)		11/273 (4%)
Cardiac disorders
Myocardial ischaemia	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Coronary artery occlusion	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Acute myocardial infarction	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Atrial fibrillation	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Mitral valve incompetence	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Ear and labyrinth disorders
Vertigo	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Gastrointestinal disorders
Alcoholic pancreatitis	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Small intestinal obstruction	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Colitis	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
General disorders
Chest pain	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Immune system disorders
Drug hypersensitivity	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Infections and infestations
Pneumonia	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Atypical pneumonia	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Appendicitis	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Endocarditis	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Injury, poisoning and procedural complications
Intentional overdose	1/650 (0.2%)	2	0/272 (0%)	0	1/273 (0.4%)	4
Gun shot wound	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Metabolism and nutrition disorders
Electrolyte imbalance	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Musculoskeletal and connective tissue disorders
Myositis	1/650 (0.2%)	1	0/272 (0%)	0	0/273 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/650 (0.2%)	1	1/272 (0.4%)	1	0/273 (0%)	0
Nervous system disorders
Cerebrovascular accident	1/650 (0.2%)	1	1/272 (0.4%)	1	0/273 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumothorax	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Pulmonary embolism	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Vascular disorders
Arterial stenosis	0/650 (0%)	0	2/272 (0.7%)	2	0/273 (0%)	0
Hypertension	0/650 (0%)	0	1/272 (0.4%)	1	0/273 (0%)	0
Venous thrombosis	0/650 (0%)	0	0/272 (0%)	0	1/273 (0.4%)	1
Other (Not Including Serious) Adverse Events
	LEO 90100 Aerosol Foam Open-label		LEO 90100 Aerosol Foam		LEO 90100 Aerosol Foam Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/650 (7.2%)		83/272 (30.5%)		87/273 (31.9%)
Eye disorders
Cataract	0/650 (0%)	0	3/272 (1.1%)	4	0/273 (0%)	0
Gastrointestinal disorders
Diarrhoea	2/650 (0.3%)	2	1/272 (0.4%)	1	3/273 (1.1%)	3
General disorders
Chest pain	1/650 (0.2%)	1	3/272 (1.1%)	3	0/273 (0%)	0
Infections and infestations
Upper respiratory tract infection	7/650 (1.1%)	7	16/272 (5.9%)	17	15/273 (5.5%)	24
Nasopharyngitis	7/650 (1.1%)	7	22/272 (8.1%)	23	19/273 (7%)	24
Influenza	2/650 (0.3%)	2	7/272 (2.6%)	7	3/273 (1.1%)	3
Urinary tract infection	2/650 (0.3%)	2	3/272 (1.1%)	3	6/273 (2.2%)	6
Bronchitis	1/650 (0.2%)	1	2/272 (0.7%)	2	5/273 (1.8%)	5
Sinusitis	2/650 (0.3%)	2	5/272 (1.8%)	5	2/273 (0.7%)	3
Gastroenteritis	3/650 (0.5%)	3	4/272 (1.5%)	4	2/273 (0.7%)	2
Folliculitis	2/650 (0.3%)	2	4/272 (1.5%)	4	2/273 (0.7%)	2
Lower respiratory tract infection	0/650 (0%)	0	3/272 (1.1%)	3	3/273 (1.1%)	3
Injury, poisoning and procedural complications
Fall	0/650 (0%)	0	5/272 (1.8%)	5	0/273 (0%)	0
Ligament sprain	1/650 (0.2%)	1	1/272 (0.4%)	2	4/273 (1.5%)	4
Joint injury	0/650 (0%)	0	3/272 (1.1%)	3	0/273 (0%)	0
Laceration	1/650 (0.2%)	1	2/272 (0.7%)	2	3/273 (1.1%)	3
Contusion	1/650 (0.2%)	1	2/272 (0.7%)	2	3/273 (1.1%)	3
Metabolism and nutrition disorders
Vitamin D deficiency	36/650 (5.5%)	36	1/272 (0.4%)	1	2/273 (0.7%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	3/650 (0.5%)	4	4/272 (1.5%)	4	6/273 (2.2%)	6
Back pain	4/650 (0.6%)	4	6/272 (2.2%)	7	4/273 (1.5%)	4
Pain in extremity	3/650 (0.5%)	3	4/272 (1.5%)	4	2/273 (0.7%)	2
Nervous system disorders
Sciatica	0/650 (0%)	0	4/272 (1.5%)	4	3/273 (1.1%)	3
Dizziness	1/650 (0.2%)	1	3/272 (1.1%)	4	0/273 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/650 (0%)	0	0/272 (0%)	0	3/273 (1.1%)	3
Skin and subcutaneous tissue disorders
Rebound psoriasis	0/650 (0%)	0	4/272 (1.5%)	4	12/273 (4.4%)	12
Psoriasis	3/650 (0.5%)	3	1/272 (0.4%)	1	7/273 (2.6%)	7
Actinic keratosis	0/650 (0%)	0	3/272 (1.1%)	3	0/273 (0%)	0
Vascular disorders
Hypertension	6/650 (0.9%)	6	4/272 (1.5%)	4	3/273 (1.1%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

LEO Pharma acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. LEO Pharma retains the right to have any publication submitted to LEO Pharma for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO Pharma.