NL-OMON30879
Completed
Phase 4
A prospective pediatric longitudinal evaluation to assess the long-term safety of tacrolimus ointment for the treatment of atopic dermatitis. - APPLES
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Astellas Pharma
- Enrollment
- 120
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Subject has/ had atopic dermatitis
- •2\) Subject has applied tacrolimus ointment 0\.03% or 0\.1% for at least 6 weeks either continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointments studies and or subjects with commercial product exposure prior to study enrollment.
- •3\) Subject age at first tacrolimus ointment exposure is /was \< 16 years.
- •4\) Subject / caregiver has given written informed and assent.
- •5\) Subject / caregiver agrees to comply with the program requirements including an annual physical examination and biennal dermatological exam and agrees to be contacted and provide information.
Exclusion Criteria
- •Not applicable
Outcomes
Primary Outcomes
Not specified
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