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Sponsored by: |
LEO Pharma |
Information provided by: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00670241 |
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).
Condition | Intervention | Phase |
Psoriasis Vulgaris |
Drug: calcipotriol and betamethasone (LEO 80185 gel) Drug: LEO 80185 vehicle Drug: Tacalcitol ointment |
Phase III |
MedlinePlus related topics: | Psoriasis |
ChemIDplus related topics: | Calcipotriene Betamethasone Bentelan Betamethasone dipropionate Tacalcitol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Study Comparing a Gel Containing Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) With Tacalcitol Ointment (4 Mcg/g) and Gel Vehicle, Used Once Daily in the Treatment of Psoriasis Vulgaris |
Estimated Enrollment: | 450 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator |
Drug: calcipotriol and betamethasone (LEO 80185 gel)
Once daily application
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2: Active Comparator |
Drug: Tacalcitol ointment
Once daily application
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3: Placebo Comparator |
Drug: LEO 80185 vehicle
Once daily application
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dusica Curcic, Ph.D | 905-747-2354 | Dusica.curcic@leo-pharma.com |
Contact: Vibeke Hoffmann, MSc Pharm | 45-4494-5888 | vibeke.hoffmann@leo-pharma.com |
Canada, Nova Scotia | |||||
Eastern Canada Cutaneous Research Associates Ltd. | Recruiting | ||||
Halifax, Nova Scotia, Canada, B3H 1Z4 | |||||
Contact: Richard Langley, MD 902-423-0482 richard.langley@dal.ca |
LEO Pharma |
Principal Investigator: | Richard Langley, MD | Eastern Canada Cutaneous Research Associates Ltd. |
Responsible Party: | LEO Pharma INC. ( Dusica Curcic, Clinical Project Manager ) |
Study ID Numbers: | LEO 80185-G21 |
First Received: | April 29, 2008 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00670241 |
Health Authority: | Canada: Health Canada |
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