Phase
Condition
Rosacea
Psoriasis And Psoriatic Disorders
Warts
Treatment
LEO 90100 aerosol foam
Aerosol foam vehicle
Gel vehicle
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years or above
Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitalsand skin folds) involving 2-30% of the Body Surface Area (BSA)
A Physician's Global Assessment of disease severity (PGA) of at least mild on trunkand limbs
A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk andlimbs.
Exclusion
Exclusion Criteria:
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Systemic treatment with biological therapies, whether marketed or not, with apossible effect on psoriasis vulgaris within the following time periods prior torandomisation:
etanercept - within 4 weeks prior to randomisation
adalimumab, infliximab - within 8 weeks prior to randomisation
ustekinumab - within 16 weeks prior to randomisation
other products - within 4 weeks/5 half-lives prior to randomisation (whicheveris longer)
Systemic treatment with all other therapies with a possible effect on psoriasisvulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and otherimmunosuppressants within 4 weeks prior to randomisation)
Subjects who have received treatment with any non-marketed drug substance (i.e. adrug which has not yet been made available for clinical use following registration)within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior torandomisation
Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation
Topical anti-psoriatic treatment on the trunk and limbs (except for emollients)within 2 weeks prior to randomisation
Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin Danalogues or prescription shampoos within 2 weeks prior to randomisation
Females who are pregnant, wishing to become pregnant during the trial or arebreastfeeding
Study Design
Connect with a study center
Service de Dermatologie, Hôspital Larrey
Toulouse, 31059
FranceSite Not Available
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