Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Long-term, Non-comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Tacrolimus Ointment 0.03%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 30 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Tacrolimus Ointment 0.03%<br>* Once or twice daily topical application<br>* Other names: Protopic 0.03%;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paediatric patients, Tacrolimus, Dermatitis, Atopic