Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

NCT ID: NCT00560326

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2006-12-31

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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Tacrolimus Ointment 0.03%

Intervention Type: DRUG

Once or twice daily topical application

Interventions

Tacrolimus Ointment 0.03%

Once or twice daily topical application

Intervention Type: DRUG

Other Intervention Names

Protopic 0.03%

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 30 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

Halifax, , Canada

Vancouver, , Canada

Waterloo, , Canada

Helsinki, , Finland

Drogheda, , Ireland

Dublin, , Ireland

Riga, , Latvia

London, , United Kingdom

Countries

Canada; Finland; Ireland; Latvia; United Kingdom

Other Identifiers

FG-506-06-33

Identifier Type: -

Identifier Source: org_study_id