Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

Study Overview
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Brief Summary
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To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.

Detailed Description
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This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.

Official Title
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Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study

Conditions
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Moderate/Severe Atopic Dermatitis

Intervention / Treatment
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* Drug: tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as AD according to Williams diagnostic criteria. Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland At least approximately 10 % of body area Patient is able to reach the centre within 3 days in case of a disease exacerbation. Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continued tacrolimus treatment<br>children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period. | Drug: tacrolimus<br> <br> * Other names: Protopic;|
| No Intervention: no additional treatment<br>children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first DE (disease exacerbation) |  | 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of DEs during the DCP |  | 6 months of DCP (Disease Control Period) | 
| Eczema Area and Severity Index (EASI) |  | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) | 
| Investigator's Global Assessment (IGA) |  | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) | 
| Duration of DE during DCP |  | 6 months of DCP (Disease Control Period) | 
| The overall efficacy during OLP |  | After 2 to 6 weeks of OLP (Open Label Period) | 
| Quantity of tacrolimus ointment used |  | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) | 
| Incidence of adverse events |  | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tacrolimus, Protopic, pediatric, atopic dermatitis, China