Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

Launched by ASTELLAS PHARMA INC · Nov 16, 2007

Keywords

ClinConnect Summary

This is a long-term, multi-centre, non-comparative phase II study. All centres participating in the FG-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. Only patients enrolled by those centres for the above mentioned study, who applied at least one dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be enrolled.

During episodes of active disease, a thin coat of ointment is applied on each lesion. In the first three weeks, frequency of application is twice a day; after three weeks treatment is continued once a day. All atopic...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient has participated in the study FG-506-06-32, has applied at least one dose of study medication and has benefited from treatment in the opinion of the investigator.
• • Patient is likely to benefit from further treatment with tacrolimus ointment in the opinion of the investigator.
• Exclusion Criteria:
• • Patient has a skin disorder on the affected (and to be treated) area, other than atopic dermatitis, requiring treatment.
• • Patient has clinically infected atopic dermatitis.