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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: |
NCT00535691 |
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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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Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis
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Scientific title:
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A Randomised, Multi-centre, Double-blind, Pharmacokinetic Study of Tacrolimus Ointment (0.03%) in Paediatric Patients (Aged 3 Months to 24 Months) With Atopic Dermatitis Following First and Repeated Once Daily or Twice Daily Application of the Tacrolimus Ointment |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00535691 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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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Canada
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Finland
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Ireland
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Latvia
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United Kingdom
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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:
- Patient is between 3 and 24 months old on Day 1.
- The patient has atopic dermatitis requiring treatment with mid potent topical
steroids.
- Patient's disease involves a percentage area to be treated greater than or equal to
5% of the total body surface area
Exclusion Criteria:
- Patient has clinically infected atopic dermatitis.
- Patient has a history of more than two courses of systemic corticosteroid treatment
Age minimum:
3 Months
Age maximum:
24 Months
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 0.03%
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Primary Outcome(s)
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Estimate the systemic exposure to tacrolimus after first and repeated application of 0.03% tacrolimus ointment in paediatric patients with atopic dermatitis stratified by application area and randomised to once a day (UID) or twice a day (BID) treatment.
[Time Frame: Day 1 and 14]
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Secondary Outcome(s)
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Efficacy of tacrolimus ointment, evaluated by examination of treated areas.
[Time Frame: Day 4, 14 and 18]
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Secondary ID(s)
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FG-506-06-32
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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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