Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560326
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Tacrolimus Ointment 0.03% Phase 2

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  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term, Non-comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients
Study Start Date : June 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Tacrolimus Ointment 0.03%
Once or twice daily topical application
Other Name: Protopic 0.03%

Primary Outcome Measures :
  1. Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00560326

Halifax, Canada
Vancouver, Canada
Waterloo, Canada
Helsinki, Finland
Drogheda, Ireland
Dublin, Ireland
Riga, Latvia
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Central Contact Astellas Pharma Europe B.V.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00560326     History of Changes
Other Study ID Numbers: FG-506-06-33
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Paediatric patients
Dermatitis, Atopic

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action