Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

August 28, 2014 updated by: Astellas Pharma Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Tacrolimus Ointment 0.03%
Once or twice daily topical application
Other Names:
  • Protopic 0.03%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

November 16, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-06-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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