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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263718
First Posted: December 9, 2005
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
LEO Pharma
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00263718     History of Changes
Other Study ID Numbers: MBL 0202 INT
First Submitted: December 8, 2005
First Posted: December 9, 2005
Last Update Posted: March 26, 2015
Last Verified: March 2015

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