Distribution of Tacrolimus in Skin, Atopic Dermatitis - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00534508

Purpose

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%.

Condition	Intervention	Phase
Dermatitis, Atopic	Drug: Tacrolimus Ointment 0.1%	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Distribution of tacrolimus in the skin after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis. [ Time Frame: Days 1, 2, 15. 18 and 21. ]

Secondary Outcome Measures:

Systemic pharmacokinetics of tacrolimus after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis. [ Time Frame: Days 1 and 14 ]

Enrollment:	14
Study Start Date:	December 2000
Study Completion Date:	July 2001
Primary Completion Date:	July 2001 (Final data collection date for primary outcome measure)

Intervention Details:

Twice daily, 14 days treatment

Other Name: Protopic 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534508

Locations

Ireland

Dublin, Ireland

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma GmbH

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00534508 History of Changes
Other Study ID Numbers:	FG-506-06-30
Study First Received:	September 21, 2007
Last Updated:	December 16, 2008
Health Authority:	Ireland: Irish Medicines Board

Keywords provided by Astellas Pharma Inc:

Skin
Pharmacokinetics
Tacrolimus
dermatitis, atopic

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012