LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

• Sponsor: LEO Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01188928
• Collaborator: (none)
• Enrollment: 1,152
• Locations: 59
• Arms: 4
• Duration (Months): 5.9
• Patients Per Site: 19.5
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: Calcipotriol plus betamethasone; Drug: Betamethasone-17,21-dipropionate; Drug: Calcipotriene; Drug: Topical suspension vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Study Comparing Once Daily Treatment With Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension With Betamethasone 0.5 mg/g (as Dipropionate) in the Topical Suspension Vehicle, Calcipotriol 50 mcg/g in the Topical Suspension Vehicle and the Topical Suspension Vehicle Alone in Subjects With Psoriasis Vulgaris on Non-scalp Regions of the Body (Trunk and/or Limbs)
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LEO 80185 Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Drug: Calcipotriol plus betamethasone; Topical suspension once daily for up to 8 weeks.
Active Comparator: Betamethasone Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Drug: Betamethasone-17,21-dipropionate; Topical suspension once daily for up to 8 weeks.
Active Comparator: Calcipotriol Calcipotriol 50 mcg/g in the topical suspension vehicle	Drug: Calcipotriene; Topical suspension once daily for up to 8 weeks.
Placebo Comparator: Topical suspension vehicle The topical suspension vehicle alone	Drug: Topical suspension vehicle; Topical suspension once daily for up to 8 weeks.

Outcome Measures

Primary Outcome Measures

1. Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4 [4 weeks]

   The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.

2. Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8 [week 8]

   The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.

Secondary Outcome Measures

1. Mean Percentage Change in PASI From Baseline to Week 4 [Baseline and 4 weeks]

   At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.

2. Mean Percentage Change in PASI From Baseline to Week 8 [Baseline and 8 weeks]

   At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Signed and dated informed consent obtained prior to any trial related activities (including any washout period).

• Aged 18 years or above

• Either sex

• Any race or ethnicity

• Attending a hospital outpatient clinic or the private practice of a board certified dermatologist.

• Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week.

• An investigator's global assessment of disease severity (IGA) of mild or moderate on the body (trunk and/or limbs) at Day 0 (Visit 1).

• A minimum modified Psoriasis Area and Severity Index (PASI) score for extent of 2 in at least one body region (i.e. psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)

• Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).

• Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner. The patients must have used the contraceptive method continually for at least 1 month prior to the pregnancy test, and must continue using the contraceptive method for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).

• Able to communicate with the investigator and understand and comply with the requirements of the study.

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 randomisation:

• etanercept - within 4 weeks prior to randomisation

• adalimumab, alefacept, infliximab - within 2 months prior to randomisation

• ustekinumab - within 4 months prior to randomisation

• experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to randomisation

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

• PUVA or Grenz ray therapy within 4 weeks prior to randomisation.

• UVB therapy within 2 weeks prior to randomisation.

• Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to randomisation.

• Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin D analogues within 2 weeks prior to randomisation.

• Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.

• Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors) during the study.

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

• Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds.

• Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

• Known or suspected severe renal insufficiency or severe hepatic disorders.

• Known or suspected hypersensitivity to component(s) of the investigational products.

• Current participation in any other interventional clinical study.

• Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation or longer, if the class of substance required a longer washout as defined above (e.g. biological treatments).

• Planned excessive exposure to the sun during the study that may affect the psoriasis vulgaris.

• Previously randomised in this study.

• Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or are breast-feeding. Females of child-bearing potential wishing to become pregnant during the study, or not using an adequate method of contraception during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Horizon Research Group, Inc	Mobile	Alabama	United States	36606
2	Burke Pharmaceutical Research	Hot Springs	Arkansas	United States	71913
3	Advanced Clinical Research Institute	Anaheim	California	United States	92801
4	DBA Torrance Clinical Research	Lomita	California	United States	90717
5	Dermatology Specialists, Inc.	Oceanside	California	United States	92056
6	Skin Surgery Medical Group, Inc.	San Diego	California	United States	92117
7	Walter Nahm, MD, Ph.D., Inc	San Diego	California	United States	92123
8	Coastal Medical Research Group, Inc.	San Luis Obispo	California	United States	93401
9	Clinical Science Institute	Santa Monica	California	United States	90404
10	Dermatology Research Centers	Santa Monica	California	United States	90404
11	Colorado Medical Research Center, Inc.	Denver	Colorado	United States	80120
12	Horizons Clinical Research Center, LLC	Denver	Colorado	United States	80220
13	Visions Clinical Research	Boynton Beach	Florida	United States	33472
14	Dermatology Associates and Research	Coral Gables	Florida	United States	33134
15	North Florida Dermatology Associates, PA	Jacksonville	Florida	United States	32204
16	International Dermatology Research, Inc.	Miami	Florida	United States	33144
17	Ameriderm Research	Ormond Beach	Florida	United States	32174
18	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
19	Atlanta Dermatology, Vein & Research Center	Alpharetta	Georgia	United States	30022
20	Peachtree Dermatology Associates	Atlanta	Georgia	United States	30327
21	Dermatologic Surgery Specialists, PC	Macon	Georgia	United States	31217
22	Gwinnett Clinical Research Center, Inc	Snellville	Georgia	United States	30078
23	Altman Dermatology Associates	Arlington Hts	Illinois	United States	60005
24	Glazer Dermatology	Buffalo Grove	Illinois	United States	60089
25	Deaconess Clinic, Inc.	Evansville	Indiana	United States	47713
26	Hudson Dermatology	Evansville	Indiana	United States	47714
27	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana	United States	46256
28	Indiana Clinical Trials Center	Plainfield	Indiana	United States	46168
29	Dermatology Specialists	Louisville	Kentucky	United States	40202
30	Owensboro Dermatology Associates	Owensboro	Kentucky	United States	42303
31	Lawrence J. Green, MD, LLC	Rockville	Maryland	United States	20850
32	David Fivenson, MD Dermatology, PLC	Ann Arbor	Michigan	United States	48103
33	Great Lakes Research Group, Inc	Bay City	Michigan	United States	48706
34	Michigan Center for Research Corp.,	Clinton Twp	Michigan	United States	48038
35	Henry Ford Health System	Detroit	Michigan	United States	48202
36	Hamzavi Dermatology	Fort Gratiot	Michigan	United States	48059
37	Somerset Skin Centre	Troy	Michigan	United States	48084
38	Grekin Skin Institute	Warren	Michigan	United States	48088
39	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
40	Karl G. Heine, M. D. Dermatology	Henderson	Nevada	United States	89052
41	Psoriasis Treatment Center of Central NJ	East Windsor	New Jersey	United States	08520
42	Anderson & Collins Clinical Research, Inc.	Edison	New Jersey	United States	08817
43	The Dermatology Group, PC	Verona	New Jersey	United States	07044
44	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
45	Mount Sinai School of Medicine	New York	New York	United States	10029
46	Derm Research Center of New York	Stony Brook	New York	United States	11790
47	Triangle Medical Research Associates, LLC	Cary	North Carolina	United States	27518
48	Haber Dermatology and Cosmetic Surgery	South Euclid	Ohio	United States	44118
49	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
50	King-Maceyko Dermatology Associates	Johnstown	Pennsylvania	United States	15905
51	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
52	J&S Studies, Inc.	College Station	Texas	United States	77845
53	Division of Dermatology, Baylor Research Institute	Dallas	Texas	United States	75246
54	Centre for Clinical Studies	Houston	Texas	United States	77030
55	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
56	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
57	Progressive Clinical Research, P.A.	San Antonio	Texas	United States	78229
58	Dermatology Research Center, Inc.	Salt Lake City	Utah	United States	84117
59	Premier Clinical Research	Spokane	Washington	United States	99204

Sponsors and Collaborators

• LEO Pharma

Investigators

• Principal Investigator: Alan Menter, MD, Division of Dermatology, Baylor Research Institute, USA
• Principal Investigator: Stephen Tyring, MD PhD, Center for Clinical Studies
• Principal Investigator: Steven A Davis, MD, Dermatology Clinical Research Center of San Antonio
• Principal Investigator: David J Cohen, MD, Dermatologic Surgery Specialists
• Principal Investigator: Mark Lee, MD, Progressive Clinical Research
• Principal Investigator: Tiffani K Hamilton, MD, Atlanta Dermatology, Vein & Research Center
• Principal Investigator: Daniel M Stewart, DO, Michigan Center for Research Corp.
• Principal Investigator: John J Goodman, MD, Palm Beach Research Center
• Principal Investigator: Terry Jones, MD, J&S Studies, Inc
• Principal Investigator: Dow Stough, MD, Burke Pharmaceutical Research
• Principal Investigator: Jerry Bagel, MD, Psoriasis Treatment Center of Central NJ
• Principal Investigator: James A Solomon, MD PhD, Ameriderm Research
• Principal Investigator: George J Murakawa, MD PhD, Somerset Skin Centre
• Principal Investigator: Michael Bukhalo, MD, Altman Dermatology Associates
• Principal Investigator: Jeffrey Moore, MD, Deaconess Clinic, Inc.
• Principal Investigator: Jaime D Weisman, MD, Peachtree Dermatology Associates Research Center
• Principal Investigator: Jonathan Kantor, MD, North Florida Dermatology Associates
• Principal Investigator: David Rodriguez, MD, Dermatology Associates and Research
• Principal Investigator: Leonard Swinyer, MD, Dermatology Research Center, Inc
• Principal Investigator: Alicia Bucko, MD, Academic Dermatology Associates
• Principal Investigator: Johnathan Weiss, MD, Gwinnett Clinical Research Center, Inc
• Principal Investigator: William P Werschler, MD, Premier Clinical Research
• Principal Investigator: Mark Lebwohl, MD, Icahn School of Medicine at Mount Sinai
• Principal Investigator: James Swinehart, MD, Colorado Medical Research Center, Inc.
• Principal Investigator: Steve Kempers, MD, Minnesota Clinical Study Center
• Principal Investigator: Dale Martin, MD, Skin Surgery Medical Group, Inc.
• Principal Investigator: Scott Guenthner, MD, Indiana Clinical Trials Center
• Principal Investigator: Kenneth Dawes, MD, Dawes Fretzin Clinical Research Group
• Principal Investigator: Scott Glazer, MD, Glazer Dermatology
• Principal Investigator: Karl G Heine, MD, Karl G. Heine, M. D. Dermatology
• Principal Investigator: Fasahat Hamzavi, MD, Hamzavi Dermatology
• Principal Investigator: Joseph Samady, MD, Dermatology Specialists, Inc.
• Principal Investigator: Artis P Truett III, MD, Owensboro Dermatology Associates
• Principal Investigator: Phoebe Rich, MD, Oregon Dermatology and Research Center
• Principal Investigator: Robin Shecter, DO, VISIONS CLINICAL RESEARCH
• Principal Investigator: Robert Haber, MD, Haber Dermatology and Cosmetic Surgery
• Principal Investigator: David Kerr, MD, Horizons Clinical Research Center, LLC
• Principal Investigator: David Fivenson, MD, David Fivenson, MD Dermatology, PLC
• Principal Investigator: Walter Nahm, MD PhD, Walter Nahm, MD, Ph.D., Inc
• Principal Investigator: Steven Grekin, DO, Grekin Skin Institute
• Principal Investigator: Joseph F Fowler, MD, Dermatology Specialists
• Principal Investigator: Jose E Mendez, DO, International Dermatology Research, Inc.
• Principal Investigator: David M Stoll, MD, Dermatology Research Centers
• Principal Investigator: Paul S Yamauchi, MD, Clinical Science Institute
• Principal Investigator: Robert Nossa, MD, The Dermatology Group, PC
• Principal Investigator: Chernila Selbert Alan, MD, DBA Torrance Clinical Research
• Principal Investigator: Brent M Boyce, MD, Great Lakes Research Group, Inc
• Principal Investigator: David B Friedman, MD, Advanced Clinical Research Institute
• Principal Investigator: Andrew King, MD, King-Maceyko Dermatology Associates
• Principal Investigator: Catherine Hren, MD, Triangle Medical Research Associates, LLC
• Principal Investigator: Elyse S Rafal, MD, Derm Research Center of New York
• Principal Investigator: John Siebenlist, MD, West Dermatolgy
• Principal Investigator: Linda Stein Gold, MD, Henry Ford Health System
• Principal Investigator: Laura K Ferris, MD PhD, University of Pittsburgh Medical Center
• Principal Investigator: Elizabeth Hughes Tichy, MD, Clinical Trials of Texas, Inc.
• Principal Investigator: Jane M Lee, MD, Anderson & Collins Clinical Research, Inc.
• Principal Investigator: Charles P Hudson, MD, Hudson Dermatology
• Principal Investigator: Amy M Morris, MD, Horizon Research Group, Inc.
• Principal Investigator: Lawrence Green, MD, Lawrence J. Green, MD, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01188928
• Other Study ID Numbers: LEO 80185-G23
• First Posted: Aug 26, 2010
• Last Update Posted: Feb 2, 2017
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Psoriasis; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate

Study Results

Participant Flow

Recruitment Details	The first subject's first visit was on 27-SEP-2010 and the last subject's last visit was on 29-MAR-2011. Hence the study had a duration of 26 weeks.

Arm/Group Title	LEO 80185	Betamethasone	Calcipotriol	Topical Suspension Vehicle
Arm/Group Description	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol 50 mcg/g in the topical suspension vehicle	The topical suspension vehicle alone
Period Title: Overall Study
STARTED	482	479	96	95
COMPLETED	444	417	82	77
NOT COMPLETED	38	62	14	18

Baseline Characteristics

Arm/Group Title	LEO 80185	Betamethasone	Calcipotriol	Topical Suspension Vehicle	Total
Arm/Group Description	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol 50 mcg/g in the topical suspension vehicle	The topical suspension vehicle alone	Total of all reporting groups
Overall Participants	482	479	96	95	1152
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.7 (13.4)	48.5 (13.8)	48 (13.7)	49.4 (13.0)	48.6 (13.5)
Gender (Count of Participants)
Female	198 41.1%	193 40.3%	36 37.5%	35 36.8%	462 40.1%
Male	284 58.9%	286 59.7%	60 62.5%	60 63.2%	690 59.9%
Region of Enrollment (participants) [Number]
United States	482 100%	479 100%	96 100%	95 100%	1152 100%

Outcome Measures

1. Primary Outcome

Title	Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4
Description	The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LEO 80185	Betamethasone	Calcipotriol	Topical Suspension Vehicle
Arm/Group Description	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol 50 mcg/g in the topical suspension vehicle	The topical suspension vehicle alone
Measure Participants	482	479	96	95
Number [participants]	64 13.3%	60 12.5%	5 5.2%	2 2.1%

2. Primary Outcome

Title	Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8
Description	The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LEO 80185	Betamethasone	Calcipotriol	Topical Suspension Vehicle
Arm/Group Description	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol 50 mcg/g in the topical suspension vehicle	The topical suspension vehicle alone
Measure Participants	482	479	96	95
Number [participants]	140 29%	103 21.5%	14 14.6%	6 6.3%

3. Secondary Outcome

Title	Mean Percentage Change in PASI From Baseline to Week 4
Description	At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LEO 80185	Betamethasone	Calcipotriol	Topical Suspension Vehicle
Arm/Group Description	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol 50 mcg/g in the topical suspension vehicle	The topical suspension vehicle alone
Measure Participants	482	479	96	95
Mean (Standard Deviation) [percentage of change in PASI]	-46.4 (30.2)	-42.7 (29.4)	-32.2 (27.3)	-17.4 (36.8)

4. Secondary Outcome

Title	Mean Percentage Change in PASI From Baseline to Week 8
Description	At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.
Time Frame	Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LEO 80185	Betamethasone	Calcipotriol	Topical Suspension Vehicle
Arm/Group Description	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Calcipotriol 50 mcg/g in the topical suspension vehicle	The topical suspension vehicle alone
Measure Participants	482	479	96	95
Mean (Standard Deviation) [percentage of change in PASI]	-55.8 (34.4)	-48.6 (35.8)	-43.6 (34.1)	-20.9 (49.1)

Adverse Events

Arm/Group Title	LEO 80185		Betamethasone		Calcipotriol		Topical Suspension Vehicle
Arm/Group Description	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension		Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle		Calcipotriol 50 mcg/g in the topical suspension vehicle		The topical suspension vehicle alone
All Cause Mortality
	LEO 80185		Betamethasone		Calcipotriol		Topical Suspension Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	LEO 80185		Betamethasone		Calcipotriol		Topical Suspension Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/482 (0.2%)		7/479 (1.5%)		0/96 (0%)		1/95 (1.1%)
Hepatobiliary disorders
Cholecystitis acute	0/482 (0%)	0	1/479 (0.2%)	1	0/96 (0%)	0	0/95 (0%)	0
Infections and infestations
Cellulitis	0/482 (0%)	0	1/479 (0.2%)	1	0/96 (0%)	0	0/95 (0%)	0
Injury, poisoning and procedural complications
Alcohol poisoning	0/482 (0%)	0	1/479 (0.2%)	1	0/96 (0%)	0	0/95 (0%)	0
Psychiatric disorders
Suicidal ideation	0/482 (0%)	0	1/479 (0.2%)	1	0/96 (0%)	0	0/95 (0%)	0
Suicide attempt	0/482 (0%)	0	0/479 (0%)	0	0/96 (0%)	0	1/95 (1.1%)	1
Renal and urinary disorders
Haematuria	0/482 (0%)	0	1/479 (0.2%)	1	0/96 (0%)	0	0/95 (0%)	0
Nephrolithiasis	0/482 (0%)	0	1/479 (0.2%)	1	0/96 (0%)	0	0/95 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/482 (0%)	0	1/479 (0.2%)	1	0/96 (0%)	0	0/95 (0%)	0
Surgical and medical procedures
Stent placement	0/482 (0%)	0	1/479 (0.2%)	1	0/96 (0%)	0	0/95 (0%)	0
Vascular disorders
Hypertension	1/482 (0.2%)	1	0/479 (0%)	0	0/96 (0%)	0	0/95 (0%)	0
Other (Not Including Serious) Adverse Events
	LEO 80185		Betamethasone		Calcipotriol		Topical Suspension Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/482 (2.9%)		15/479 (3.1%)		5/96 (5.2%)		3/95 (3.2%)
Infections and infestations
Nasopharyngitis	14/482 (2.9%)		15/479 (3.1%)		5/96 (5.2%)		3/95 (3.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Prior to submitting or presenting a manuscript relating to the clinical trial to a publisher, reviewer, or other outside person, the Investigator shall provide to LEO a copy of all such manuscripts, and LEO shall have rights to review and comment. Upon the request of LEO the Investigator shall remove any confidential information (other than results generated by the Investigator) prior to submitting or presenting the manuscripts.