Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris - Full Text View

Sponsored by:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00263718

Purpose

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.

Condition	Intervention	Phase
Psoriasis Vulgaris	Drug: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel	Phase II

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcipotriene Betamethasone Bentelan Betamethasone dipropionate

U.S. FDA Resources

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

Further study details as provided by LEO Pharma:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	360
Study Start Date:	December 2005
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263718

Locations

Canada, Ontario
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A3H7
Germany
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Ireland
Waterford Regional Hospital
Waterford, Ireland
Sweden
Läkarhuset Vällingby
Vällingby, Sweden, 16268
United Kingdom, Scotland
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY

Sponsors and Collaborators

LEO Pharma

Investigators

Principal Investigator:

Colin Fleming, MD

Ninewells Hospital and Medical School, Ninewells, Dundee, UK

More Information

Study ID Numbers:	MBL 0202 INT
Study First Received:	December 8, 2005
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00263718
Health Authority:	Canada: Health Canada; Ireland: Irish Medicines Board; Sweden: Medical Products Agency; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Calcipotriene
Betamethasone-17,21-dipropionate
Sodium phosphate
Skin Diseases

Psoriasis
Betamethasone sodium phosphate
Betamethasone
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Dermatologic Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009