Trial Information

Summary: The purpose of this study is to test the safety and effectiveness of ALTANA'S 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 ALTANA's Tacrolimus or PROTOPIC (Tacrolimus) or medically inactiveplacebo ointment.

The purpose of this study is to test the safety and effectiveness of ALTANA'S 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 ALTANA's 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.