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

University of California (UC) Davis

Status and phase

Withdrawn

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00368719

200614402-1

Details and patient eligibility

About

To assess the long-term safety of tacrolimus ointment

Full 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.

Sex

All

Ages

2 to 16 years old

Volunteers

Accepts Healthy Volunteers

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