Trial Information

Summary: Males and Females, at least 8 years old, with atopic dermatitis or eczema are needed for a research study.

The purpose of this study is to test the safety and effectiveness of tacrolimus oint. To those of PROTOPIC (Tacrolimus) for males or females at least 8 years of age with atopic dermatitis that is moderate to severe. The study will last about 4 weeks, requiring about 4 visits to the office. Qualified participants will receive either tacrolimus or PROTOPIC (Tacrolimus) or medically inactiveplacebo ointment.

Patient Inclusion Criteria:

• M/F at least 8 years of age
• Moderate to severe AD with BSA 10%
• Use of medically acceptable contraception if female of child bearing potential

Patient Exclusion Criteria:

• Other skin conditions that may interfere with study assessments
• Systemic steroids in past 4 weeks (inhaled or intranasal corticosteroids are allowed if stable dose)
• Immunosuppressive agents (cyclosporine, methotrexate)
• Biologics for atopic disease or psoriasis within the last 3 months or a period of five times the half life of the biological.
• Topical AD meds within two weeks
• Topical Antihistamines within 7 days.
• Phototherapy within 4 weeks

If you would like to learn more about participating in this study, please send an e-mail message using the form below.