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Clinical Trials/NL-OMON30879
NL-OMON30879CompletedPhase 4

A prospective pediatric longitudinal evaluation to assess the long-term safety of tacrolimus ointment for the treatment of atopic dermatitis. - APPLES

Astellas Pharma0 sites120 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
120
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
2 to 99 (—)

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

Investigators

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