LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-02-28

Brief Summary

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The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

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Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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LEO 90100

LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks

Group Type EXPERIMENTAL

LEO 90100 aerosol foam

Intervention Type DRUG

Aerosol foam vehicle

Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks

Group Type PLACEBO_COMPARATOR

Aerosol foam vehicle

Intervention Type DRUG

Calcipotriol BDP gel

Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks

Group Type ACTIVE_COMPARATOR

Calcipotriol BDP gel

Intervention Type DRUG

Gel vehicle

Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks

Group Type PLACEBO_COMPARATOR

Gel vehicle

Intervention Type DRUG

Interventions

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LEO 90100 aerosol foam

Intervention Type DRUG

Aerosol foam vehicle

Intervention Type DRUG

Calcipotriol BDP gel

Intervention Type DRUG

Gel vehicle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or above
* 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 Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs
* A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs.

Exclusion Criteria

* Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
* 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
* 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 (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 randomisation)
* Subjects who have received treatment with any non-marketed drug substance (i.e. a drug 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 to randomisation
* 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 D analogues or prescription shampoos within 2 weeks prior to randomisation
* Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No