Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Aug 24, 2006

Keywords

ClinConnect Summary

To assess the long-term safety of tacrolimus ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis under actual use conditions, including the risk of developing cutaneous or systemic malignancies. The FDA and EMEA approved Tacrolimus ointment, 0.03% in children and 0.1% and 0.03% in adults, for the treatment of atopic dermatitis. As part of the approval process, the FDA and EMEA requested a post-marketing commitment regarding the safety of long-term use of Tacrolimus ointment in pediatric atopic dermatitis subjects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject has/had atopic dermatitis.
• • Subject has applied tacrolimus ointment 0.03% or 0.1% for at least 6 weeks, continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointment studies and/or subjects with commercial product exposure prior to study enrollment.
• • Subject age at the first tacrolimus ointment exposure is/was \<16 years of age.
• • Subject/Caregiver has given written informed consent and assent as required by state and/or governmental laws, including access to all relevant clinical and medication data, and the storage and analysis of these data.
• • Subject/Caregiver agrees to comply with the program requirements including an annual physical exam and biennial dermatological exam and agrees to be contacted and provide information as described in this document to Primary Investigator Dr. Lamb and Covance Periapproval Services, Inc.
• Exclusion Criteria:
• • Subjects who do not have/ have not had Atopic Dermatitis.
• • Subjects must have used Tacrolimus ointment prior to age 16.