NCT00560326

Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

A Long-term, Non-comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 6 Months – 30 Months
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.

Detailed description

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 dermatitis lesions are treated until clearance (i.e. itch has gone). In case of a flare-up or worsening treatment twice daily treatment is re-started for three weeks and thereafter reduced to once daily. Safety is assessed from adverse events reported by the patient and/or his parents or observed by the investigator at the site of application and elsewhere. The safety evaluation includes monitoring of routine haematology and serum chemistry parameters. Blood samples are analysed by local laboratories. Blood samples are taken to determine concentrations of tacrolimus. Height, weight and pulse of the patient are recorded at each visit. Efficacy is assessed by physician's global evaluation of clinical response, patient's parent/guardian's assessment of global response, physician's assessment of individual signs and the affected area assessment.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Tacrolimus Ointment 0.03%	Once or twice daily topical application

Timeline

• Start date: 2003-06-01
• Completion: 2006-12-01
• First posted: 2007-11-19
• Last updated: 2014-09-01

Locations

8 sites across 5 countries: Canada, Finland, Ireland, Latvia, United Kingdom