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

Inclusion criteria
Patients with moderate-to-severe AD according to both Hanifin and Rajka (1980) and
the Rajka and Langeland (1989) criteria were eligible for Studies I, II, III, and V. A
body surface area (BSA) of AD of 5 to 60% was required for Study I and 5 to 100% for
Studies II, III, and V. All the patients in Studies II and V had participated in previous
tacrolimus ointment studies, one of 3 weeks' or 6 or 12 months' duration (Kang et al.
2001, Reitamo et al. 2002). Before entering the new study, all participants spent a
tacrolimus-free interim period of 4 to 12 months in which treatment with topical
corticosteroids was allowed. Study IV included patients who had been treated with
0.03% tacrolimus ointment for severe atopic blepharoconjunctivitis and had provided a
conjunctival cytology sample prior to and within 3 months from the start of their
treatment.
Concomitant treatments
Prohibited therapies in Studies I, II, and V included other investigational drugs, UVlight
therapy, non-steroidal immunosuppressants, topical medicated agents, and the
systemic antihistamines astemizole and terfenadine. In addition, no systemic and topical
corticosteroids were allowed during the first 6 months of Studies II and V. After that,
rescue therapy for AD exacerbations of a maximum of 2 weeks in every 3 months was
allowed. Use of non-steroidal anti-inflammatory agents was restricted. Emollients were
not allowed for 2 hours prior to or after application of tacrolimus ointment. Inhaled
corticosteroids at doses up to 1 mg/day were permitted for treatment of bronchial
asthma or allergic rhinitis; this was also valid for Study III. For wash-out periods see
Table 4.
In Study IV, eye-drops containing sodium chromoglycate or its derivatives for
conjunctivitis symptoms were allowed if use had preceded tacrolimus treatment. Prior
to the first dose of tacrolimus ointment, all patients had been without topical or systemic
antihistamines and glucocorticoids for at least 2 weeks.
Exclusion criteria
Exclusion criteria are presented in Table 5. In Study IV, exclusion criteria were
concomitant topical or systemic antihistamine, glucocorticoid, or ciclosporin treatment
or another significant disease affecting the ocular area.
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