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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
transdermal
Unnamed facility
S. Giovanni Rotondo, Foggia, Italy
Unnamed facility
Battipaglia, Salerno, Italy
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
Time frame: 1 year
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
Time frame: 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)
Time frame: 1 year
The incidence of adverse events during the study, including all clinically significant laboratory values
Time frame: 1 year
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Unnamed facility
Ancona, Italy
Unnamed facility
Bari, Italy
Unnamed facility
Benevento, Italy
Unnamed facility
Bergamo, Italy
Unnamed facility
Bolzano, Italy
Unnamed facility
Catania, Italy
Unnamed facility
Genova, Italy
Unnamed facility
Mantua, Italy
...and 16 more locations