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

Phase 4

Withdrawn

• Conditions: Atopic Dermatitis
• Interventions: Drug: Tacrolimus

• Registration Number: NCT00368719
• Lead Sponsor: University of California, Davis

Brief Summary

To assess the long-term safety of tacrolimus ointment

Detailed Description

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.

Study Timeline

• Study First Submitted: 2006-08-24
• Study First Submitted QC: 2006-08-24
• Study First Posted: 2006-08-25
• Study Start: 2007-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects	10 Years