Objective of this study is to further assess the response to treatment and safety of 0.03% tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to severe atopic dermatitis, known to be responsive to topical steroids.
The main phase is 6 month duration, but the follow-up phase up to 12 months will allow the collection of RTT and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect AD course.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
transdermal
Unnamed facility
Bologna, Italy
Unnamed facility
Catania, Italy
Unnamed facility
Genova, Italy
Unnamed facility
Lecco, 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 before 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 (if before month 6) visit and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)
Time frame: 1 year
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Unnamed facility
Naples, Italy
Unnamed facility
Padova, Italy
Unnamed facility
Roma, Italy
Unnamed facility
Roma, Italy
Unnamed facility
Roma, Italy