Distribution of Tacrolimus in Skin, Atopic Dermatitis

Study Overview
=================
Brief 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%.

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.

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.

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: Tacrolimus Ointment 0.1%


Participation Criteria
=================
Eligibility 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus Ointment 0.1%|Twice daily, 14 days treatment|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of tacrolimus in the skin after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis. |  | Days 1, 2, 15. 18 and 21. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic pharmacokinetics of tacrolimus after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis. |  | Days 1 and 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin, Pharmacokinetics, Tacrolimus, dermatitis, atopic