Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 accoun...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00691145
Start Date
October 1 2002
End Date
February 1 2005
Last Update
September 1 2014
Active Locations (26)
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1
S. Giovanni Rotondo, Foggia, Italy, 71013
2
Battipaglia, Salerno, Italy, 84091
3
Ancona, Italy, 60020
4
Bari, Italy, 70124