- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02899962
LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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British Columbia
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Surrey, British Columbia, Canada, V3R 6A7
- Dr. Chih-ho Hong Medical
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Vancouver, British Columbia, Canada, V6E 4M3
- Pacific Dermaesthetics
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Wiseman Dermatology Research
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New Brunswick
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Bathurst, New Brunswick, Canada, E2A 4Z9
- Maritime Medical Research Centre
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Fredericton, New Brunswick, Canada, E3B 1G9
- Brunwick Dermatology Center
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Ontario
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Ajax, Ontario, Canada, L1S 7K8
- CCA Medical Research
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Hamilton, Ontario, Canada, L8N 1V6
- Dermatrials Research Incorporated
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London, Ontario, Canada, N6A 3B4
- The Guenther Dermatology Research Centre
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Markham, Ontario, Canada, L3P 1X2
- Lynderm Research
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Peterborough, Ontario, Canada, K9J 5K2
- Skin Center for Dermatology
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Waterloo, Ontario, Canada, N2J 1C4
- K. Papp Clinical Research
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Quebec
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Quebec City, Quebec, Canada, J2B 5L4
- Clinique du Dre Isabelle Delorme Inc
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Brest, Francia, 29609
- CHRU de Brest - Hôpital Morvan
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Nice, Francia, 06202
- C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie
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Rennes, Francia, 35033
- CHU de Rennes - Hopital Pontchaillou
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Valence, Francia, 26000
- Centre Hospitalier de Valence
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Saint-Etienne
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Saint Etienne, Saint-Etienne, Francia, 42055
- C.H.U. de Saint-Etienne Service de Dermatologie
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Dresden, Germania, 01307
- Klinik und Poliklinik für Dermatologie
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Erlangen, Germania, 91054
- Universitätsklinikum Erlangen
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Essen, Germania, 54122
- Universitätsklinikum Essen (AöR), Klinik für Dermatologie
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Gera, Germania, 07548
- SRH Wald-Klinikum Gera
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Hamburg, Germania, 20354
- SCIderm GmbH
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Lubeck, Germania, 23538
- UKSH - Campus Lübeck
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Mahlow, Germania, 15831
- Michael Sebastian
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Munchen, Germania, 80337
- LMU Poliklinik Derma & Allergo
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Schweinfurt, Germania, 97421
- Gemein. Weber & Crainic
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Kraków, Polonia, 31-123
- Małopolskie Centrum Kliniczne
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Lublin, Polonia, 20-079
- NZOZ Med-laser
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Poznań, Polonia, 60-425
- Solumed
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Rzeszów, Polonia, 35-030
- Kliniczny Szpital Wojewódzki, Klinika Dermatologii
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Salford, Regno Unito, M6 8HD
- Dermatopharmacology Department
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Cambridgeshire
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Wansford, Cambridgeshire, Regno Unito, PE8 6PL
- Wansford and Kings Cliffe Prac
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Derbyshire
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Chesterfield, Derbyshire, Regno Unito, S40 4AA
- Ashgate Medical Practice
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Leicstershire
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Burbage, Leicstershire, Regno Unito, LE10 2SE
- Burbage Surgery
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Northamptonshire
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Wellingborough, Northamptonshire, Regno Unito, NN8 4RW
- Albany House Medical Centre
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Warwickshire
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Leamington Spa, Warwickshire, Regno Unito, CV32 4RA
- Sherbourne Medical Centre
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West Yorkshire
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Leeds, West Yorkshire, Regno Unito, LS7 4SA
- Chapel Allerton Hospital
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California
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Fremont, California, Stati Uniti, 94538
- Center for Dermatology Clinical Research
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Santa Monica, California, Stati Uniti, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, Stati Uniti, 80210
- Colorado Medical Research Center
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Florida
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Miami, Florida, Stati Uniti, 33144
- International Dermatology Research
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Illinois
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Arlington Heights, Illinois, Stati Uniti, 60005
- Arlington Dermatology
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40217
- Derm Research
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Maryland
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Rockville, Maryland, Stati Uniti, 20850
- Dermassociates
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Michigan
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Clarkston, Michigan, Stati Uniti, 48346
- Clarkston Skin Research
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Medical Center - New Center One
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Kalamazoo, Michigan, Stati Uniti, 49009
- Beyer Research
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New Jersey
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East Windsor, New Jersey, Stati Uniti, 08520
- Psoriasis Treatment Center of Central NJ
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New York
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New York, New York, Stati Uniti, 10029
- Mount Sinai School of Medicine
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New York, New York, Stati Uniti, 10075
- Sadick Research Group
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Rochester, New York, Stati Uniti, 14623
- Skin Search of Rochester
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- UPMC Department of Dermatology
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Tennessee
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Goodlettsville, Tennessee, Stati Uniti, 37072
- Rivergate Dermatology Clinical Research Center
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Knoxville, Tennessee, Stati Uniti, 37922
- The Skin Wellness Center
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Nashville, Tennessee, Stati Uniti, 37215
- Tennessee Clinical Research Center
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Texas
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San Antonio, Texas, Stati Uniti, 78229
- Clinical Trials of Texas
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Webster, Texas, Stati Uniti, 77598
- Center for Clinical Studies
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Washington
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Spokane, Washington, Stati Uniti, 99202
- Premier Clinical Research
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: LEO 90100 aerosol foam
Topical application twice weekly for 52 weeks
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LEO 90100 aerosol foam twice weekly
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Comparatore placebo: LEO 90100 aerosol foam vehicle
Topical application twice weekly for 52 weeks
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LEO 90100 aerosol foam vehicle twice weekly
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Time to First Relapse
Lasso di tempo: From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
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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
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From Randomisation (Week 4) until first relapse or End of Treatment (Week 56 or early withdrawal)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Proportion of Days in Remission During the Maintenance Phase
Lasso di tempo: From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
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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
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From Randomisation (Week 4) until End of Treatment (Week 56 or early withdrawal)
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Number of Relapses During the Maintenance Phase
Lasso di tempo: From Randomisation (Week 4) until End of Treatment (Week 56)
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Defined as number of 4-week periods with use of once-daily rescue investigational medicinal product
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From Randomisation (Week 4) until End of Treatment (Week 56)
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LP0053-1004
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Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Psoriasi volgare
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Galderma R&DCompletatoGrave acne vulgarisStati Uniti, Canada, Porto Rico
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Sebacia, Inc.CompletatoAcne Vulgaris infiammatoriaStati Uniti
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Nexgen Dermatologics, Inc.SconosciutoACNE VULGARISStati Uniti
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InMode MD Ltd.Attivo, non reclutanteAcne Vulgaris infiammatoriaStati Uniti
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityReclutamentoAcne vulgaris da moderata a graveCina
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PollogenLumenis Be Ltd.ReclutamentoAcne vulgaris da moderata a graveStati Uniti
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Boston PharmaceuticalsCompletatoAcne vulgaris da moderata a graveStati Uniti, Canada
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Bispebjerg HospitalCompletatoAcne Vulgaris e RosaceaDanimarca
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Assiut UniversityCompletato
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Zagazig UniversityCompletatoAcne Vulgaris Superficiale Mista Comedonica e InfiammatoriaEgitto
Prove cliniche su LEO 90100 aerosol foam
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LEO PharmaCompletato
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LEO PharmaCompletatoMalattie della pelle e del tessuto connettivoFrancia
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LEO PharmaCompletato
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LEO PharmaCompletato
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LEO PharmaCompletatoMalattie della pelle e del tessuto connettivoFrancia
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LEO PharmaCompletatoPsoriasi volgareGiappone
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LEO PharmaCompletato
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LEO PharmaCompletato