Topical tacrolimus in atopic dermatitis: Effects of ... - Helda - Helsinki.fi

SUBJECTS AND METHODS
Study designs
All studies were carried out in Skin and Allergy Hospital, Helsinki University Central
Hospital, Helsinki, Finland, and were approved by the local ethics committee of
Helsinki Central Hospital. All subjects gave their written informed consent before the
start of the study. Use of tacrolimus ointment in Studies I, II, and V was permitted by
the National Agency for Medicines (Lääkelaitos). Studies I, II, and V were single-center
studies conducted in the context of prospective, multicenter, open-label, noncomparative,
long-term safety studies in patients with moderate-to-severe AD using
tacrolimus 0.1% ointment twice daily as an intermittent treatment. Study I included 6month
and 12-month populations. Study II lasted for 12 to 24 months, and Study V for
48 months. Study III was a cross-section study of AD patients and Study IV a
retrospective study of patients with atopic blepharoconjunctivitis who were using 0.03%
tacrolimus ointment.
Subjects
Male and female patients over 18 years of age were eligible for Studies I, II, and IV.
Studies III and V included patients over age 13. For more characteristics, see Table 3.
Table 3. Characteristics of and reasons for withdrawal among study populations.
Subjects N Age
Gender: Length of Discontinued (N:)
females follow-up reasons
Study I 19 31.7 15 6 months
9 30.0 8 12 months
Study II: Tacrolimus 56 26.8 35 12-24 months 3: pregnancy, lack of
efficacy, adverse event
Corticosteroid 36 25.8 26 12 months
Healthy 27 28.7 21
Study III: AD patients 86 25.7 57
Controls 49 26.9 13
Study IV 10 33.0 6 6 (4-13) wk
Study V 65 25.5 41 48 months 3: pregnancy, lack of
efficacy, adverse event
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