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

Terminated

• Conditions: Atopic Dermatitis

• Registration Number: NCT00475605
• Lead Sponsor: LEO Pharma

Brief Summary

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

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 Timeline

• Study Start: 2005-05-25
• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-17
• Study First Posted: 2007-05-21
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8071

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of systemic or cutaneous malignancy	10 years	Standardised Incidence Ratio (versus population cancer rates)

Trial Locations

Locations (301)

Shelby Dermatology; 🇺🇸 Alabaster, Alabama, United States

Pediatric Care Center of NE Alabama; 🇺🇸 Anniston, Alabama, United States

Total Skin and Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Metro Pediatrics, P.C; 🇺🇸 Birmingham, Alabama, United States

Pediatric & Adult Asthma and Allergy, P.C.; 🇺🇸 Birmingham, Alabama, United States

Skin Wellness Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Southview Dermatology; 🇺🇸 Birmingham, Alabama, United States

Ruth A Yates; 🇺🇸 Huntsville, Alabama, United States

Alliance Dermatology; 🇺🇸 Phoenix, Arizona, United States

Derma; 🇺🇸 Phoenix, Arizona, United States

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