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

Stopped early

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT00475605

Run by

LEO Pharma

People needed

8071

Starts

2005-05-25

Expected to finish

2019-01-31

Last updated by the study team

2019-12-18

Who can join

Age: any, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• 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
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Hull Dermatology, P.A. — Rogers, Arkansas, United States
• Coastal Allergy Care — Camarillo, California, United States
• Tien Nguyen — Fountain Valley, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• California Skin Institute — Mountain View, California, United States
• Capital Allergy & Respiratory Disease Center — Roseville, California, United States
• Allergy and Immunology Clinic — San Diego, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• California Dermatology Care — San Ramon, California, United States
• Connecticut Children's Medical Center Dept of Dermatology — Hartford, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Webster Dermatology, PA — Hockessin, Delaware, United States
• Atlantic Skin & Cosmetic Surgery Group — Wilmington, Delaware, United States
• Shelby Dermatology — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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