Distribution of Tacrolimus in Skin, Atopic Dermatitis
Distribution of Tacrolimus in Skin, Atopic Dermatitis
This study was designed to further increase the understanding of the pharmacokinetics of
 tacrolimus in the affected skin of atopic dermatitis patients following repeated topical
 application of tacrolimus ointment 0.1%.
The study was conducted on an out-patient basis, with patients self-administering the
 ointment twice daily at home. However, on Days 1 and 14 there was only a single application
 of ointment and this was applied by the Investigator or his/her designee in the clinic. An
 area of the affected skin was selected for skin biopsy of sufficient size for 5 biopsy
 samples. The biopsy samples were taken from the same lesion(s) if possible or from an
 adjacent lesion in the same anatomical area at all times. All areas selected for treatment
 were treated with tacrolimus ointment 0.1% for a period of two weeks with a follow up period
 of one week. Two pharmacokinetic profiles (Days 1 and 14) and five skin biopsy samples (Days
 1, 2, 15, 18 and 21) were taken.
Inclusion Criteria:

 -  Using the Hanifin and Rajka Criteria, the patient has a diagnosis of moderate to
 severe atopic dermatitis

 -  Using the Rajka and Langeland grading system, the patient's atopic dermatitis score is
 at least 4.5 (moderate to severe)

 Exclusion Criteria:

 -  Patient has a serious skin disorder other than atopic dermatitis.

 -  Patient has history of eczema herpeticum (defined as an acute disseminated cutaneous
 herpes simplex type 1 or 2 infection associated with constitutional symptoms like
 fever, headache, malaise, regional or generalised lymphadenopathy in an individual
 with eczema).