Back to resultsEfficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Calcipotriol plus betamethasone dipropionate (LEO 80185) gel
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility 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
Sites / Locations
- The Guenther Dermatology Research Centre
- Universitätsklinikum Leipzig
- Waterford Regional Hospital
- Läkarhuset Vällingby
- Ninewells Hospital and Medical School
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00263718
Brief Title
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
LEO Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Calcipotriol plus betamethasone dipropionate (LEO 80185) gel
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.
Title
Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6.
Title
Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Fleming, MD
Organizational Affiliation
Ninewells Hospital and Medical School, Ninewells, Dundee, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A3H7
Country
Canada
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Waterford Regional Hospital
City
Waterford
Country
Ireland
Facility Name
Läkarhuset Vällingby
City
Vällingby
ZIP/Postal Code
16268
Country
Sweden
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris
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