Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dermatitis, Atopic
Intervention: Tacrolimus Ointment 0.03% (Drug)
Phase: Phase 2
Sponsored by: Astellas Pharma Inc
Official(s) and/or principal investigator(s):
Central Contact, Study Chair, Affiliation: Astellas Pharma Europe BV
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.
Official title: A Long-Term, Non-Comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations
Secondary outcome: Assess efficacy from parameters as follows:
- Physician's global evaluation of clinical response
- Physician's assessment of individual signs
- Affected area
- Parent/guardian's assessment of global response
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
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.
Minimum age: 6 Months.
Maximum age: 30 Months.
- 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.
- 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.
Locations and Contacts
London, United Kingdom
Starting date: June 2003
Ending date: December 2006
Last updated: November 16, 2007