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| Sponsored by: |
Astellas Pharma Inc |
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00475605 |
Purpose
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.
| Condition |
|
Atopic Dermatitis |
| ChemIDplus related topics: | Tacrolimus Tacrolimus anhydrous |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis |
| Estimated Enrollment: | 8000 |
| Study Start Date: | May 2005 |
The study is a large, prospective, multinational, observational cohort study. 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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: APPLES Study Line | (877) 277-7530 | clintrials.info@us.astellas.com |
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Show 250 Study Locations |
| Astellas Pharma Inc |
| Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
More Information
| Study ID Numbers: | 03-0-161, FG506-06-37 |
| First Received: | May 17, 2007 |
| Last Updated: | June 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00475605 |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
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