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A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis

Conditions

Atopic Dermatitis

Trial Phase

N/A

Trial Purpose and Description

Trial 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.


Trial 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.

Participation Guidelines

Age:
Up to 16 Years
Gender:
Both

Eligibility Criteria


Inclusion Criteria:

- Subjects who first used Protopic7 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.
Sponsor:
Astellas Pharma Inc
Dates:
May 2005
Last Updated:
March 31, 2011
Study HIC#:
0506000135

Clinicaltrials.gov ID: NCT00475605