Official Title: “Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle and the Gel Vehicle Alone in Psoriasis Vulgaris”

The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks.

The primary response criterion is the number of patients with controlled disease at week 8.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary:

• Patients with "controlled disease" (minimal or clear and at least two steps change from baseline) according to the investigators' global assessment of disease severity at week 4 and week 8.

Secondary:

• The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.
• Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6.
• Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.

Inclusion Criteria:

• Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week
• An investigators' global assessment of disease severity of at least mild

Exclusion Criteria:

• PUVA or Grenz ray therapy within 4 weeks prior to randomisation
• UVB therapy within 2 weeks prior to randomisation
• Systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within 6 months prior to randomisation
• Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
• Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation
• Topical treatment for other relevant skin disorders (except WHO group I-II corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation
• Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study
• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Lead Sponsor: LEO Pharma

The Guenther Dermatology Research Centre

London Ontario N6A3H7 Canada

Universitätsklinikum Leipzig

Leipzig  04103 Germany

Waterford Regional Hospital

Waterford   Ireland

Läkarhuset Vällingby

Vällingby  16268 Sweden

Ninewells Hospital and Medical School

Dundee Scotland DD1 9SY United Kingdom

Overall Clinical Trial Officials and Contacts

Colin Fleming, MD Principal Investigator Ninewells Hospital and Medical School, Ninewells, Dundee, UK  

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00263718

Study ID Number: MBL 0202 INT

ClinicalTrials.gov Identifier: NCT00263718

Health Authority: Canada: Health Canada