Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus ointment for 12 months in adults with moderate to severe atopic dermatitis.

Detailed Description
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The main phase is 6 months duration, but the follow up phase up to 12 months will allow the collection of efficacy and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect atopic dermatitis course.

Official Title
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A Long-term, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus (FK506) Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis FG-506-06-IT-01

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: tacrolimus ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient may be male or female of any ethnic group Patient without restricted legal competence, and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5) Patient known to be responsive to topical steroids Patient is capable of understanding the purposes and risks of the trial and has given written Informed Consent Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study Patient meets the following criteria: Topical corticosteroids Systemic corticosteroids (for the treatment of AD only) Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate) Other investigational drugs Light Treatments (UVA, UVB) Patient has not taken and agrees not to take for the complete study period any medication or therapy prohibited by the protocol Exclusion Criteria: Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma Patient is pregnant or breast-feeding Patient has a skin infection on the affected (and to be treated) area Patient has a known hypersensitivity to macrolides in general, to tacrolimus or any excipient of the ointment Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one Any form of substance abuse (including drug or alcohol abuse),psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator Patient is known to be HIV positive

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tacrolimus ointment<br>* transdermal<br>* Other names: FK506 ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of patients with at least 50%(i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 12/end of study (if after month 6) visit |  | 1 year | 
| The rate of patients with at least 60% improvement in the Score In Atopic Dermatitis (SCORAD) at month 6/end of study visit (if before month 6) and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1) |  | 1 year | 
| The incidence of adverse events during the study, including all clinically significant laboratory values |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, Tacrolimus ointment