Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT00691145
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
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Patient may be male or female of any ethnic group
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Patient without restricted legal competence, and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5)
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Patient known to be responsive to topical steroids
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Patient is capable of understanding the purposes and risks of the trial and has given written Informed Consent
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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
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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)
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Patient has not taken and agrees not to take for the complete study period any medication or therapy prohibited by the protocol
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 tacrolimus ointment -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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