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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00436540 |
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Date of registration:
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16/02/2007 |
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Primary sponsor: |
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Public title:
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A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam
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Scientific title:
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A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate (Olux®) Foam With Regard to Efficacy, Safety, Preference and Duration of Response in Stable Plaque Psoriasis |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00436540 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ronald W. Gottschalk, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Galderma Laboratories, LP |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects must have a clinical diagnosis of moderate to severe plaque psoriasis,
defined as 3%-20% of the body surface area involved
Exclusion Criteria:
- Subjects who have surface area involvement too large that would require more than 50
grams per week of Clobex® spray or more than 50 grams per week of Olux® foam
- Subjects whose psoriasis involves the scalp, face or groin
- Subjects with non-plaque psoriasis or other related diseases not classified as plaque
psoriasis
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: Clobetasol Propionate 0.05% Foam
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Drug: Clobetasol Propionate 0.05% Spray
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Primary Outcome(s)
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Efficacy - Body Surface Area, Investigator Global Severity
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Safety - Tolerability assessments, adverse events
[Time Frame: 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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