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

• Status: Withdrawn
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the long-term safety of tacrolimus ointment

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Treatments: Tacrolimus

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.