LEO 90100 in the Treatment of Psoriasis Vulgaris

• Sponsor: LEO Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01536938
• Collaborator: (none)
• Enrollment: 303
• Locations: 33
• Arms: 3
• Duration (Months): 6
• Patients Per Site: 9.2
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone are effective in the treatment of psoriasis vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: LEO 90100; Drug: Calcipotriol; Drug: Betamethasone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 303 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Calcipotriol Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks	Drug: Calcipotriol
Active Comparator: Betamethasone Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Drug: Betamethasone
Experimental: 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	Drug: LEO 90100; Other Names: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

Outcome Measures

Primary Outcome Measures

1. 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. [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.

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 washout period).

• Age 18 years or above

• Either sex

• Any race or ethnicity

• All skin types

• 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).

• 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 8 weeks prior to randomisation

• ustekinumab - within 16 weeks prior to randomisation

• other products - 4 weeks/5 half-lives (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 randomisation.

• Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.

• PUVA therapy within 4 weeks prior to randomisation.

• UVB therapy within 2 weeks prior to randomisation.

• Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the study.

• Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, 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, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds.

• Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris.

• 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.

• Previously randomised in this study.

• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burke Pharmaceutical Research	Hot Springs	Arkansas	United States	71913
2	Dermatology Research Associates	Los Angeles	California	United States	90045
3	Dermatology Specialists, Inc.	Oceanside	California	United States	92056
4	Skin Surgery Medical Group, Inc	San Diego	California	United States	92117
5	University Clinical Trials, Inc.	San Diego	California	United States	92123
6	Clinical Science Institute	Santa Monica	California	United States	90404
7	Colorado Medical Research Center, Inc	Denver	Colorado	United States	80210
8	Horizons Clinical Research Center	Denver	Colorado	United States	80220
9	Dermatology Associates and Research	Coral Gables	Florida	United States	33134
10	North Florida Dermatology Associates, PA	Jacksonville	Florida	United States	32204
11	International Dermatology Research, Inc.	Miami	Florida	United States	33144
12	Altman Dermatology Associates	Arlington Heights	Illinois	United States	60005
13	Glazer Dermatology	Buffalo Grove	Illinois	United States	60089
14	Clinical Research Advantage, Inc./Hudson Dermatology, LLC	Evansville	Indiana	United States	47714
15	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana	United States	46256
16	The Indiana Clinical Trials Center	Plainfield	Indiana	United States	46168
17	Owensboro Dermatology Associates	Owensboro	Kentucky	United States	42303
18	David Fivenson, MD, PLC	Ann Arbor	Michigan	United States	48103
19	Great Lakes Research Group, Inc.	Bay City	Michigan	United States	48706
20	Derm Center	Troy	Michigan	United States	48084
21	Grekin Skin Institute	Warren	Michigan	United States	48008
22	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
23	Psoriasis Treatment Center of Central NJ	East Windsor	New Jersey	United States	08520
24	The Dermatology Group, PC	Verona	New Jersey	United States	07044
25	Derm Research Center of New York	Stony Brook	New York	United States	11790
26	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania	United States	19034
27	Menter Dermatology Research Institute	Dallas	Texas	United States	75246
28	Center for Clinical Studies	Houston	Texas	United States	77065
29	Clinical Trials of Texas, Inc	San Antonio	Texas	United States	78229
30	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
31	Progressive Clinical Research	San Antonio	Texas	United States	78229
32	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23507
33	Premier Clinical Research	Spokane	Washington	United States	99204

Sponsors and Collaborators

• LEO Pharma

Investigators

• Principal Investigator: Mark Lebwohl, M.D., MOUNT SINAI HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

• Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, Olesen M, Lowson D, Yamauchi P. Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase 2 Study. J Clin Aesthet Dermatol. 2016 Feb;9(2):34-41. Epub 2016 Feb 1.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01536938
• Other Study ID Numbers: LEO 90100-7
• First Posted: Feb 22, 2012
• Last Update Posted: May 9, 2016
• Last Verified: Apr 1, 2016

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

Study Results

Participant Flow

Recruitment Details	First Subject First Visit: 07-MAY-2012 Last Subject Last Visit: 10-OCT-2012
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	LEO 90100	Betamethasone Dipropionate	Calcipotriol Aerosol Foam	Total
Arm/Group Description	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 aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks	Total of all reporting groups
Overall Participants	100	101	101	302
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.4 (14.8)	49.0 (14.4)	50.7 (14.7)	49.0 (14.7)
Sex: Female, Male (Count of Participants)
Female	47 47%	45 44.6%	40 39.6%	132 43.7%
Male	53 53%	56 55.4%	61 60.4%	170 56.3%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LEO 90100	Betamethasone Dipropionate	Calcipotriol Aerosol Foam
Arm/Group Description	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 aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks	Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
Measure Participants	100	101	101
Number [participants]	45 45%	31 30.7%	15 14.9%

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	LEO 90100		Betamethasone Dipropionate		Calcipotriol Aerosol Foam
Arm/Group Description	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 aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks		LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
All Cause Mortality
	LEO 90100		Betamethasone Dipropionate		Calcipotriol Aerosol Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	LEO 90100		Betamethasone Dipropionate		Calcipotriol Aerosol Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/100 (1%)		0/99 (0%)		0/99 (0%)
Immune system disorders
Hypersensitivity	1/100 (1%)	1	0/99 (0%)	0	0/99 (0%)	0
Other (Not Including Serious) Adverse Events
	LEO 90100		Betamethasone Dipropionate		Calcipotriol Aerosol Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/99 (0%)		0/99 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.