Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560326
• Other study ID #: FG-506-06-33
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2007
• Last updated: August 28, 2014
• Start date: June 2003
• Est. completion date: December 2006

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyLatvia: State Agency of MedicinesCanada: Health CanadaIreland: Irish Medicines BoardUnited Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 30 Months

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Tacrolimus Ointment 0.03%
Once or twice daily topical application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Canada,  Finland,  Ireland,  Latvia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations		24 months
Secondary	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		24 months

External Links

•   Link to Results on JAPIC - enter 140564 in the JapicCTI-RNo. field