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

NCT00263718 | Completed Phase 2

• 1 other identifier: MBL 0202 INT
• Study Type: interventional
• Target: 360
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Interventions

Calcipotriol plus betamethasone dipropionate (LEO 80185) gel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (5)

The Guenther Dermatology Research Centre

London, Ontario, N6A3H7, Canada

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Waterford Regional Hospital

Waterford, Ireland

Location

Läkarhuset Vällingby

Vällingby, 16268, Sweden

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Interventions

calcipotriene; betamethasone-17,21-dipropionate; Gels

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Colin Fleming, MD

  Ninewells Hospital and Medical School, Ninewells, Dundee, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2005
• First Posted: December 9, 2005
• Study Start: December 1, 2005
• Study Completion: May 1, 2006
• Last Updated: February 24, 2025

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); IE (1); CA (1); DE (1); GB (1)