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

This study has been completed.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00263718
First received: December 8, 2005
Last updated: February 20, 2008
Last verified: February 2008
  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 2

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

Resource links provided by NLM:


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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00263718     History of Changes
Other Study ID Numbers: MBL 0202 INT
Study First Received: December 8, 2005
Last Updated: February 20, 2008
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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 22, 2014