Clinical trial NCT00560326: Tacrolimus Ointment Long Term Safety in Young Children 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: Paediatric patients
Tacrolimus
Dermatitis, Atopic
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations
timeFrame: 24 months
Secondary outcomes:
measure: 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 - EASI
timeFrame: 24 months
Other outcomes:
Locations:
city: Halifax
country: Canada
city: Vancouver
country: Canada
city: Waterloo
country: Canada
city: Helsinki
country: Finland
city: Drogheda
country: Ireland
city: Dublin
country: Ireland
city: Riga
country: Latvia
city: London
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_CHAIR
References: