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| Tracking Information | |||||
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| First Received Date ICMJE | October 21, 2005 | ||||
| Last Updated Date | August 7, 2007 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Overall disease severity according to investigator's assessment at week 8 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00243464 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis | ||||
| Official Title ICMJE | Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis | ||||
| Brief Summary | The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment. Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Psoriasis of Scalp | ||||
| Intervention ICMJE | Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | May 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium, Canada, Denmark, France, Sweden | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00243464 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | MBL 0503 INT | ||||
| Study Sponsor ICMJE | LEO Pharma | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | LEO Pharma | ||||
| Verification Date | August 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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