A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)
NCT ID: NCT02416258
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2015-04-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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LP0113 aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
Aerosol spray vehicle
LEO 90100 aerosol foam
Betamethasone dipropionate aerosol spray
Calcipotriol aerosol spray
Daivobet® gel
Aerosol spray vehicle
No active ingredient, topical
LP0113 aerosol spray
LEO 90100 aerosol foam
Betamethasone dipropionate aerosol spray
Calcipotriol aerosol spray
Daivobet® gel
LEO 90100 aerosol foam
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
LP0113 aerosol spray
Aerosol spray vehicle
Betamethasone dipropionate aerosol spray
Calcipotriol aerosol spray
Daivobet® gel
Betamethasone dipropionate aerosol spray
Betamethasone (as dipropionate) 0.5 mg/g, topical
LP0113 aerosol spray
Aerosol spray vehicle
LEO 90100 aerosol foam
Calcipotriol aerosol spray
Daivobet® gel
Calcipotriol aerosol spray
Calcipotriol (as monohydrate) 50 mcg/g, topical
LP0113 aerosol spray
Aerosol spray vehicle
LEO 90100 aerosol foam
Betamethasone dipropionate aerosol spray
Daivobet® gel
Daivobet® gel
Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical
LP0113 aerosol spray
Aerosol spray vehicle
LEO 90100 aerosol foam
Betamethasone dipropionate aerosol spray
Calcipotriol aerosol spray
Interventions
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LP0113 aerosol spray
Aerosol spray vehicle
LEO 90100 aerosol foam
Betamethasone dipropionate aerosol spray
Calcipotriol aerosol spray
Daivobet® gel
Eligibility Criteria
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Inclusion Criteria
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
* Age 18 years or above
* Outpatients
* Female subjects must be of either
* non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
* child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
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 and during the trial
* Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
* Ustekinumab - within 16 weeks prior to randomisation and during the trial
* Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
* Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,
* Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
* PUVA: 4 weeks
* UVB: 2 weeks
* Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
* Potent or very potent (WHO group III-IV) corticosteroids
* Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:
* WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
* Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid
* Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
* Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
* Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Locations
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Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, , France
Countries
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Related Links
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Clinical Trials at LEO Pharma
Other Identifiers
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2014-004759-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LP0113-1123
Identifier Type: -
Identifier Source: org_study_id
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