Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263718
• Other study ID #: MBL 0202 INT
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2005
• Last updated: March 25, 2015
• Start date: December 2005
• Est. completion date: May 2006

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaIreland: Irish Medicines BoardSweden: Medical Products AgencyGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Calcipotriol plus betamethasone dipropionate (LEO 80185) gel

Locations

Country	Name	City	State
Canada	The Guenther Dermatology Research Centre	London	Ontario
Germany	Universitätsklinikum Leipzig	Leipzig
Ireland	Waterford Regional Hospital	Waterford
Sweden	Läkarhuset Vällingby	Vällingby
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  Germany,  Ireland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.
Secondary	Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6.
Secondary	Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.

External Links

•   Clinical Trials at LEO Pharma