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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00534508 |
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Date of registration:
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21/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Distribution of Tacrolimus in Skin, Atopic Dermatitis
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Scientific title:
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A Study to Determine the Distribution of Tacrolimus in the Skin and the Systemic Pharmacokinetics of Tacrolimus in Adult Patients With Moderate to Severe Atopic Dermatitis Following First and Repeated Application of the Tacrolimus Ointment. |
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Date of first enrolment:
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December 2000 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00534508 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma GmbH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Using the Hanifin and Rajka Criteria, the patient has a diagnosis of moderate to
severe atopic dermatitis
- Using the Rajka and Langeland grading system, the patient's atopic dermatitis score
is at least 4.5 (moderate to severe)
Exclusion Criteria:
- Patient has a serious skin disorder other than atopic dermatitis.
- Patient has history of eczema herpeticum (defined as an acute disseminated cutaneous
herpes simplex type 1 or 2 infection associated with constitutional symptoms like
fever, headache, malaise, regional or generalised lymphadenopathy in an individual
with eczema).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dermatitis, Atopic
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Intervention(s)
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Drug: Tacrolimus Ointment 0.1%
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Primary Outcome(s)
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Distribution of tacrolimus in the skin after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis.
[Time Frame: Days 1, 2, 15. 18 and 21.]
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Secondary Outcome(s)
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Systemic pharmacokinetics of tacrolimus after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis.
[Time Frame: Days 1 and 14]
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Secondary ID(s)
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FG-506-06-30
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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