Status:
WITHDRAWN
Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis
Lead Sponsor:
University of California, Davis
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
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 syste...
Eligibility Criteria
Inclusion
- 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
- Subjects who do not have/ have not had Atopic Dermatitis.
- Subjects must have used Tacrolimus ointment prior to age 16.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00368719
Start Date
September 1 2007
End Date
July 1 2016
Last Update
April 7 2015
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