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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: |
NCT00480896 |
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Date of registration:
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30/05/2007 |
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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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Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
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Scientific title:
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Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Children" |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00480896 |
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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 (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Czech Republic
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Finland
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France
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Germany
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Hungary
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Italy
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Netherlands
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Portugal
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Spain
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United Kingdom
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Contacts
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Name:
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Use 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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Universitätsklinikum Frankfurt Zentrum für Dermatologie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female patient of any ethnic group
- Patient was at least 2-15 years old and suffered from mild to severe atopic
dermatitis (Rajka/Langeland score of at least 3)
Exclusion Criteria:
- Patient had a genetic epidermal barrier defect such as Netherton's syndrome or
generalised erythroderma
- Patient had a clinically significant skin infection on the affected (and to be
treated) area
Age minimum:
2 Years
Age maximum:
15 Years
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: Placebo ointment
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Drug: tacrolimus ointment
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Primary Outcome(s)
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Number of exacerbations of atopic dermatitis requiring intervention.
[Time Frame: 12 months]
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Secondary Outcome(s)
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Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response.
[Time Frame: 12 months]
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Secondary ID(s)
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FG-506-06-41
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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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