- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00248456
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
February 20, 2008 updated by: LEO Pharma
A Randomised, Double-Blind, Active-Controlled, Parallel, Multi-Center Study to Investigate the Efficacy and Safety of Daivobet® Ointment in Patients With Psoriasis Vulgaris
This study will evaluate the efficacy and safety of calcipotriol plus betamethasone dipropionate ointment compared with calcipotriol ointment in the treatment of patients with psoriasis vulgaris for a duration of 4 weeks.
The study will focus on the percentage change of the psoriasis area and severity index (PASI) from baseline to the end of week 4.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
320
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China, 200040
- Fudan University First Hospital, Dermatology Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of psoriasis vulgaris in a stable condition
- Extent of at least 10% of one or more body regions
- Amenable to topical therapy with maximum of 100 g/week of investigational product
Exclusion Criteria:
- Patients with more than 30% of body surface area involved
- Patients with facial psoriasis who need treatment
- Patients who need treatment of scalp psoriasis with WHO group IV topical corticosteroids, tretinoin or topical vitamin D derivatives
- Patients with unstable forms of psoriasis including guttate, erythrodermic, pustular, or arthritis psoriasis
- Systemic treatment of psoriasis with corticosteroids or other therapy
- Systemic antipsoriatic treatment (e.g. corticosteroids, immunosuppressive drugs, tretinoin, antibiotics, phototherapy or calcium agents) within 4 weeks prior to visit 1; or topical antipsoriatic treatment (e.g. keratolytics, topical corticosteroids, topical vitamin D derivatives, anthralin, crude coal tar, etc) within the previous 2 week period
- Patients with planned exposure to phototherapy that may affect the psoriasis during the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The percentage change of PASI at the end of week 4 compared with baseline
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Secondary Outcome Measures
Outcome Measure |
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The change of PASI at the end of week 4 compared with baseline
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The change of Dermatology Life Quality Index at the end of week 4 compared with baseline
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Physician's Global Assessment at the end of week 4
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Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4
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The change of individual scores of redness, thickness, and scaliness at the end of week 4 on the target lesion compared with baseline
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The change of overall lesion area percentage (scalp and face area excluded) at the end of week 4 compared with baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zheng Zhi Zhong, Professor, Fudan University First Hospital, Dermatology Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
November 3, 2005
First Submitted That Met QC Criteria
November 3, 2005
First Posted (Estimate)
November 4, 2005
Study Record Updates
Last Update Posted (Estimate)
February 21, 2008
Last Update Submitted That Met QC Criteria
February 20, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Calcipotriene
- Betamethasone sodium phosphate
Other Study ID Numbers
- EX 0501 CN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis Vulgaris
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LEO PharmaCompletedPlaque Psoriasis | Psoriasis VulgarisGermany
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SoligenixRecruitingPsoriasis | Plaque Psoriasis | Psoriasis VulgarisUnited States
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LEO PharmaTerminatedPsoriasis | Plaque Psoriasis | Psoriasis VulgarisBelgium, Germany, Italy, Spain, Denmark, Austria, France, Greece, Switzerland, United Kingdom, Netherlands, Sweden
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PRCL Research Inc.CompletedPlaque Psoriasis | Psoriasis VulgarisCanada, Slovakia, Ukraine
-
Chinese University of Hong KongNot yet recruitingPsoriasis Vulgaris
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University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
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University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationRecruitingPsoriasis VulgarisUnited States
-
University of California, San FranciscoSun Pharmaceutical Industries LimitedRecruiting
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Centre for Human Drug Research, NetherlandsJanssen PharmaceuticalsRecruiting
Clinical Trials on Calcipotriol plus betamethasone dipropionate ointment
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LEO PharmaCompleted
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Xijing HospitalCompleted
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LEO PharmaCompleted
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LEO PharmaCompletedPsoriasis of ScalpCanada, Denmark, France, Norway, Portugal, Spain, Sweden, United Kingdom
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LEO PharmaCompletedPsoriasis VulgarisIreland, Germany, United Kingdom, Canada, Sweden
-
LEO PharmaCompletedPsoriasis of ScalpCanada, Belgium, Finland, France, Germany, Netherlands, United Kingdom
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DFB Soria, LLCBioskin GmbH; US Biotest, Inc.CompletedPlaque PsoriasisUnited States
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University of British ColumbiaUnknown
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LEO PharmaCompletedPsoriasis of ScalpFrance, Canada, Belgium, Denmark, Sweden
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LEO PharmaCompletedPsoriasis of ScalpCanada, Denmark, France, Germany, United Kingdom