A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123) (NCT02416258) | Clinical Trial Compass
CompletedPhase 2
A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)
France50 participantsStarted 2015-04
Plain-language summary
The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to DaivobetĀ® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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:
* Female subjects who are breast feeding
* 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 withinā¦
What they're measuring
1
Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)
Timeframe: End of treatment compared to baseline - 4 weeks