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| Descriptive Information Fields | |||||
| Brief Title † | A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis | ||||
| Official Title † | APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis | ||||
| Brief Summary | This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial. |
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| Detailed Description | Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Cohort, Prospective | ||||
| Primary Outcome Measure † | The endpoint is the occurrence of serious adverse events, including the observation of systemic and cutaneous malignancies [ Time Frame: At six month intervals for ten years ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Atopic Dermatitis | ||||
| Intervention † | |||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 8000 | ||||
| Start Date † | May 2005 | ||||
| Completion Date | December 2023 | ||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 16 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States, Canada, Germany, Ireland, United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00475605 | ||||
| Organization ID | 03-0-161 | ||||
| Secondary IDs †† | FG506-06-37 | ||||
| Study Sponsor † | Astellas Pharma Inc | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Astellas Pharma Inc | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | May 17, 2007 | ||||
| Last Updated Date | July 31, 2008 | ||||
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