Dermatitis, Atopic Clinical Trial
Official title:
A Long-term, Non-comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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