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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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18 March 2013 |
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Main ID: |
NCT00568997 |
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Date of registration:
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05/12/2007 |
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Primary sponsor: |
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Public title:
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10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
PEER |
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Scientific title:
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A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two Years to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Elidel Cream 1% (Pimecrolimus) |
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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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8000 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00568997 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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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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NA NA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Valeant Pharmaceuticals |
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Address:
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Telephone:
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908-927-1400 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- males and females
- greater than or equal to 2 years and less than or equal to 17 years at enrollment
- diagnosis of atopic dermatitis (confirmed by treating physician)
- applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks
Exclusion Criteria:
- past or present history of systemic malignancy, skin malignancy, or
lymphoproliferative disease
- past or present use of oral immunosuppressive therapy
Age minimum:
2 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Drug: Pimecrolimus
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Primary Outcome(s)
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The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
[Time Frame: 10 years of observation with 6-month reporting intervals]
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Secondary Outcome(s)
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The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
[Time Frame: 10 years of observation with 6-month reporting intervals]
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The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
[Time Frame: 10 years of observation with 6-month reporting intervals]
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The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream
[Time Frame: 10 years of observation with 6-month reporting intervals]
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Secondary ID(s)
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CASM981C2311
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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