A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)
- Conditions
- Skin and Connective Tissue Diseases
- Interventions
- Drug: Aerosol spray vehicleDrug: LP0113 aerosol sprayDrug: LEO 90100 aerosol foamDrug: Daivobet® gel
- Registration Number
- NCT02416258
- Lead Sponsor
- LEO Pharma
- Brief Summary
The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
-
Signed and dated informed consent has been obtained
-
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.
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Age 18 years or above
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Outpatients
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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.
-
Female subjects who are breast feeding
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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)
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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,
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Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
- PUVA: 4 weeks
- UVB: 2 weeks
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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
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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
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Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
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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
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Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Betamethasone dipropionate aerosol spray Daivobet® gel Betamethasone (as dipropionate) 0.5 mg/g, topical LP0113 aerosol spray 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 Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical LP0113 aerosol spray Betamethasone dipropionate aerosol spray Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical LP0113 aerosol spray Calcipotriol aerosol spray Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical LP0113 aerosol spray Daivobet® gel Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Aerosol spray vehicle LP0113 aerosol spray No active ingredient, topical Aerosol spray vehicle Daivobet® gel No active ingredient, topical LEO 90100 aerosol foam LP0113 aerosol spray Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical LEO 90100 aerosol foam Aerosol spray vehicle Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical LEO 90100 aerosol foam Daivobet® gel Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Aerosol spray vehicle LEO 90100 aerosol foam No active ingredient, topical Betamethasone dipropionate aerosol spray LP0113 aerosol spray Betamethasone (as dipropionate) 0.5 mg/g, topical Betamethasone dipropionate aerosol spray Aerosol spray vehicle Betamethasone (as dipropionate) 0.5 mg/g, topical Betamethasone dipropionate aerosol spray LEO 90100 aerosol foam Betamethasone (as dipropionate) 0.5 mg/g, topical Betamethasone dipropionate aerosol spray Calcipotriol aerosol spray Betamethasone (as dipropionate) 0.5 mg/g, topical Calcipotriol aerosol spray LP0113 aerosol spray Calcipotriol (as monohydrate) 50 mcg/g, topical Calcipotriol aerosol spray Aerosol spray vehicle Calcipotriol (as monohydrate) 50 mcg/g, topical Calcipotriol aerosol spray LEO 90100 aerosol foam Calcipotriol (as monohydrate) 50 mcg/g, topical Calcipotriol aerosol spray Daivobet® gel Calcipotriol (as monohydrate) 50 mcg/g, topical Daivobet® gel LP0113 aerosol spray Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Daivobet® gel Aerosol spray vehicle Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Daivobet® gel LEO 90100 aerosol foam Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Daivobet® gel Betamethasone dipropionate aerosol spray Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Daivobet® gel Calcipotriol aerosol spray Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Aerosol spray vehicle Calcipotriol aerosol spray No active ingredient, topical LEO 90100 aerosol foam Calcipotriol aerosol spray Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Aerosol spray vehicle Betamethasone dipropionate aerosol spray No active ingredient, topical LEO 90100 aerosol foam Betamethasone dipropionate aerosol spray Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Calcipotriol aerosol spray Betamethasone dipropionate aerosol spray Calcipotriol (as monohydrate) 50 mcg/g, topical
- Primary Outcome Measures
Name Time Method Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration) End of treatment compared to baseline - 4 weeks
- Secondary Outcome Measures
Name Time Method Absolute change in single clinical sign score: erythema, scaling, infiltration End of treatment and individual visits compared to baseline - 4 weeks Absolute change in total skin thickness and echo-poor band thickness End of treatment compared to baseline - 4 weeks Absolute Change in Total Clinical Score (TCS) Individual visits compared to baseline - 4 weeks
Trial Locations
- Locations (1)
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
🇫🇷Nice, France