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NCT00475605

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

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8071 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-25

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atopic Dermatitis

Keywords

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atopic dermatitis child tacrolimus ointment Protopic Ointment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1. Protopic Exposure

Pediatric subjects whose ages are/were \<16 years at the time of first tacrolimus ointment exposure

No interventions assigned to this group

Eligibility Criteria

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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.

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LEO Pharma A/S

Role: STUDY_DIRECTOR

Medical Expert

Locations

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Shelby Dermatology

Alabaster, Alabama, United States

Site Status