Dermatitis, Atopic
Conditions
Keywords
Atopic dermatitis, Tacrolimus ointment
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.
Interventions
DRUGtacrolimus ointment
transdermal
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Italy
Outcome results
None listed