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

LEO Pharma8,071 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

8,071

Conditions

Atopic Dermatitis

Eligibility

Sex: ALLMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (313)

Outcomes

Primary Outcomes

Occurrence of systemic or cutaneous malignancy

Standardised Incidence Ratio (versus population cancer rates)

Time frame: 10 years

Data from ClinicalTrials.gov

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Shelby Dermatology

Alabaster, Alabama, United States

Pediatric Care Center of NE Alabama

Anniston, Alabama, United States

Total Skin and Beauty Dermatology Center