LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
1 other identifier
interventional
722
6 countries
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2017
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2016
CompletedFirst Posted
Study publicly available on registry
September 14, 2016
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2019
CompletedResults Posted
Study results publicly available
August 20, 2020
CompletedAugust 20, 2020
August 1, 2020
2.4 years
September 9, 2016
July 10, 2020
August 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Relapse
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
From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
Secondary Outcomes (2)
Proportion of Days in Remission During the Maintenance Phase
From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
Number of Relapses During the Maintenance Phase
From Randomisation (Week 4) until End of Treatment (Week 56)
Study Arms (2)
LEO 90100 aerosol foam
ACTIVE COMPARATORTopical application twice weekly for 52 weeks
LEO 90100 aerosol foam vehicle
PLACEBO COMPARATORTopical application twice weekly for 52 weeks
Interventions
LEO 90100 aerosol foam vehicle twice weekly
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (58)
Center for Dermatology Clinical Research
Fremont, California, 94538, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Colorado Medical Research Center
Denver, Colorado, 80210, United States
International Dermatology Research
Miami, Florida, 33144, United States
Arlington Dermatology
Arlington Heights, Illinois, 60005, United States
Derm Research
Louisville, Kentucky, 40217, United States
DermAssociates
Rockville, Maryland, 20850, United States
Clarkston Skin Research
Clarkston, Michigan, 48346, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, 08520, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Sadick Research Group
New York, New York, 10075, United States
Skin Search of Rochester
Rochester, New York, 14623, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213, United States
Rivergate Dermatology Clinical Research Center
Goodlettsville, Tennessee, 37072, United States
The Skin Wellness Center
Knoxville, Tennessee, 37922, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Dr. Chih-ho Hong Medical
Surrey, British Columbia, V3R 6A7, Canada
Pacific Dermaesthetics
Vancouver, British Columbia, V6E 4M3, Canada
Wiseman Dermatology Research
Winnipeg, Manitoba, R3M 3Z4, Canada
Maritime Medical Research Centre
Bathurst, New Brunswick, E2A 4Z9, Canada
Brunwick Dermatology Center
Fredericton, New Brunswick, E3B 1G9, Canada
CCA Medical Research
Ajax, Ontario, L1S 7K8, Canada
Dermatrials Research Incorporated
Hamilton, Ontario, L8N 1V6, Canada
The Guenther Dermatology Research Centre
London, Ontario, N6A 3B4, Canada
Lynderm Research
Markham, Ontario, L3P 1X2, Canada
SKiN Center for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
Clinique du Dre Isabelle Delorme Inc
Québec, Quebec, J2B 5L4, Canada
C.H.U. de Saint-Etienne Service de Dermatologie
Saint-Etienne, Saint-Etienne, 42055, France
CHRU de Brest - Hôpital Morvan
Brest, 29609, France
C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
Nice, 06202, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
Centre Hospitalier de Valence
Valence, 26000, France
Klinik und Poliklinik für Dermatologie
Dresden, 01307, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Essen (AöR), Klinik für Dermatologie
Essen, 54122, Germany
SRH Wald-Klinikum Gera
Gera, 07548, Germany
SCIderm GmbH
Hamburg, 20354, Germany
UKSH - Campus Lübeck
Lübeck, 23538, Germany
Michael Sebastian
Mahlow, 15831, Germany
LMU Poliklinik Derma & Allergo
München, 80337, Germany
Gemein. Weber & Crainic
Schweinfurt, 97421, Germany
Małopolskie Centrum Kliniczne
Krakow, 31-123, Poland
NZOZ Med-laser
Lublin, 20-079, Poland
Solumed
Poznan, 60-425, Poland
Kliniczny Szpital Wojewódzki, Klinika Dermatologii
Rzeszów, 35-030, Poland
Wansford and Kings Cliffe Prac
Wansford, Cambridgeshire, PE8 6PL, United Kingdom
Ashgate Medical Practice
Chesterfield, Derbyshire, S40 4AA, United Kingdom
Burbage Surgery
Burbage, Leicstershire, LE10 2SE, United Kingdom
Albany House Medical Centre
Wellingborough, Northamptonshire, NN8 4RW, United Kingdom
Sherbourne Medical Centre
Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom
Chapel Allerton Hospital
Leeds, West Yorkshire, LS7 4SA, United Kingdom
Dermatopharmacology Department
Salford, M6 8HD, United Kingdom
Related Publications (3)
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.
PMID: 35297108DERIVEDLebwohl 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.
PMID: 34339017DERIVEDStein 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.
PMID: 32965655DERIVED
Results Point of Contact
- Title
- Clinical Disclosure Specialist
- Organization
- LEO Pharma A/S
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Lebwohl, MD
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2016
First Posted
September 14, 2016
Study Start
February 15, 2017
Primary Completion
June 26, 2019
Study Completion
June 26, 2019
Last Updated
August 20, 2020
Results First Posted
August 20, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share