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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 21, 2007 | ||||
| Last Updated Date | August 4, 2008 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Subjects' Overall preference [ Time Frame: study end ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Subjects’ Overall preference | ||||
| Change History | Complete list of historical versions of study NCT00438399 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Global Severity score (GSS),Total severity score (TSS) [ Time Frame: at the end of each treatment period ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Global Severity score (GSS),Total severity score (TSS) | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Subject Preference for Scalp Psoriasis Treatment | ||||
| Official Title ICMJE | Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis | ||||
| Brief Summary | The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress. Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair. The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects. The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis. |
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| Detailed Description | This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups. In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Scalp Psoriasis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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 | 240 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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 | Italy | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00438399 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | RD.03.SPR.29064, Eudract n°2006-003073-27 | ||||
| Study Sponsor ICMJE | Galderma | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Galderma | ||||
| Verification Date | August 2008 | ||||
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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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