LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
NCT ID: NCT02899962
Last Updated: 2020-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
722 participants
INTERVENTIONAL
2017-02-15
2019-06-26
Brief Summary
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A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LEO 90100 aerosol foam
Topical application twice weekly for 52 weeks
LEO 90100 aerosol foam
LEO 90100 aerosol foam twice weekly
LEO 90100 aerosol foam vehicle
Topical application twice weekly for 52 weeks
LEO 90100 aerosol foam vehicle
LEO 90100 aerosol foam vehicle twice weekly
Interventions
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LEO 90100 aerosol foam
LEO 90100 aerosol foam twice weekly
LEO 90100 aerosol foam vehicle
LEO 90100 aerosol foam vehicle twice weekly
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Lebwohl, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Center for Dermatology Clinical Research
Fremont, California, United States
Clinical Science Institute
Santa Monica, California, United States
Colorado Medical Research Center
Denver, Colorado, United States
International Dermatology Research
Miami, Florida, United States
Arlington Dermatology
Arlington Heights, Illinois, United States
Derm Research
Louisville, Kentucky, United States
DermAssociates
Rockville, Maryland, United States
Clarkston Skin Research
Clarkston, Michigan, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, United States
Beyer Research
Kalamazoo, Michigan, United States
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Sadick Research Group
New York, New York, United States
Skin Search of Rochester
Rochester, New York, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
Rivergate Dermatology Clinical Research Center
Goodlettsville, Tennessee, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Dr. Chih-ho Hong Medical
Surrey, British Columbia, Canada
Pacific Dermaesthetics
Vancouver, British Columbia, Canada
Wiseman Dermatology Research
Winnipeg, Manitoba, Canada
Maritime Medical Research Centre
Bathurst, New Brunswick, Canada
Brunwick Dermatology Center
Fredericton, New Brunswick, Canada
CCA Medical Research
Ajax, Ontario, Canada
Dermatrials Research Incorporated
Hamilton, Ontario, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Lynderm Research
Markham, Ontario, Canada
SKiN Center for Dermatology
Peterborough, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Clinique du Dre Isabelle Delorme Inc
Québec, Quebec, Canada
C.H.U. de Saint-Etienne Service de Dermatologie
Saint-Etienne, Saint-Etienne, France
CHRU de Brest - Hôpital Morvan
Brest, , France
C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
Nice, , France
CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
Centre Hospitalier de Valence
Valence, , France
Klinik und Poliklinik für Dermatologie
Dresden, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen (AöR), Klinik für Dermatologie
Essen, , Germany
SRH Wald-Klinikum Gera
Gera, , Germany
SCIderm GmbH
Hamburg, , Germany
UKSH - Campus Lübeck
Lübeck, , Germany
Michael Sebastian
Mahlow, , Germany
LMU Poliklinik Derma & Allergo
München, , Germany
Gemein. Weber & Crainic
Schweinfurt, , Germany
Małopolskie Centrum Kliniczne
Krakow, , Poland
NZOZ Med-laser
Lublin, , Poland
Solumed
Poznan, , Poland
Kliniczny Szpital Wojewódzki, Klinika Dermatologii
Rzeszów, , Poland
Wansford and Kings Cliffe Prac
Wansford, Cambridgeshire, United Kingdom
Ashgate Medical Practice
Chesterfield, Derbyshire, United Kingdom
Burbage Surgery
Burbage, Leicstershire, United Kingdom
Albany House Medical Centre
Wellingborough, Northamptonshire, United Kingdom
Sherbourne Medical Centre
Royal Leamington Spa, Warwickshire, United Kingdom
Chapel Allerton Hospital
Leeds, West Yorkshire, United Kingdom
Dermatopharmacology Department
Salford, , United Kingdom
Countries
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References
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Guenther L, Takhar A, Megna M, Sebastian M, Nyholm N, Thoning H, Levin LA. Impact of fixed-dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52-week randomized, double-blind, PSO-LONG trial. J Eur Acad Dermatol Venereol. 2022 Jul;36(7):1054-1063. doi: 10.1111/jdv.18053. Epub 2022 Mar 28.
Lebwohl MG, Papp KA, Morch MH, Bernasconi MYJ, Warren RB. Long-Term Proactive Treatment of Plaque Psoriasis with Calcipotriene/Betamethasone Dipropionate Foam Prolongs Remission and Reduces Relapses Irrespective of Patient Baseline Characteristics. Dermatol Ther (Heidelb). 2021 Oct;11(5):1657-1665. doi: 10.1007/s13555-021-00585-x. Epub 2021 Aug 2.
Stein Gold L, Alonso-Llamazares J, Lacour JP, Warren RB, Tyring SK, Kircik L, Yamauchi P, Lebwohl M; PSO-LONG Trial Investigators. PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis. Adv Ther. 2020 Nov;37(11):4730-4753. doi: 10.1007/s12325-020-01497-6. Epub 2020 Sep 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LP0053-1004
Identifier Type: -
Identifier Source: org_study_id
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