Distribution of Tacrolimus in Skin, Atopic Dermatitis
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dermatitis, Atopic
Intervention: Tacrolimus Ointment 0.1% (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Central Contact, Study Chair, Affiliation: Astellas Pharma GmbH
Summary
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%.
Clinical Details
Official title: A Study to Determine the Distribution of Tacrolimus in the Skin and the Systemic Pharmacokinetics of Tacrolimus in Adult Patients With Moderate to Severe Atopic Dermatitis Following First and Repeated Application of the Tacrolimus Ointment.
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Distribution of tacrolimus in the skin after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis.
Secondary outcome: Systemic pharmacokinetics of tacrolimus after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Dublin, Ireland
Additional Information
Starting date: December 2000
Ending date: July 2001
Last updated: September 21, 2007
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