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APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

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Trial Conditions
  • Atopic Dermatitis
What is the purpose of this trial?

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.

Date & Status


Who can Participate?


0  - 16 



Inclusion Criteria:

- Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age
and were treated for at least 6 weeks for the treatment of Atopic dermatitis may
enroll into the study.

Gender: Both
Steward Physician(s)
  • Medical Director
Physician Researcher

Investigator Name:

  • Medical Director

Other Information

Sponsor: Astellas Pharma Inc
Phase: N/A
Trial ID: NCT00475605
Volunteers:  Not Accepting Healthy Volunteers

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