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

Condition(s) targeted: Psoriasis Vulgaris (Plaque Psoriasis)

Intervention: LEO 90100 aerosol foam (Drug); Aerosol foam vehicle (Drug); Calcipotriol BDP gel (Drug); Gel vehicle (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: LEO Pharma

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

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Treatment success according to the PGA

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Service de Dermatologie, Hôspital Larrey, Toulouse 31059, France

Starting date: June 2014
Last updated: May 6, 2015