Distribution of Tacrolimus in Skin, Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534508
• Other study ID #: FG-506-06-30
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2007
• Last updated: September 17, 2014
• Start date: December 2000
• Est. completion date: July 2001

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Tacrolimus Ointment 0.1%
Twice daily, 14 days treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

Reitamo S, Mandelin J, Rubins A, Remitz A, Mäkelä M, Cirule K, Rubins S, Zigure S, Ho V, Dickinson J, Undre N. The pharmacokinetics of tacrolimus after first and repeated dosing with 0.03% ointment in infants with atopic dermatitis. Int J Dermatol. 2009 Apr;48(4):348-55. doi: 10.1111/j.1365-4632.2009.03853.x. — View Citation

Undre NA, Moloney FJ, Ahmadi S, Stevenson P, Murphy GM. Skin and systemic pharmacokinetics of tacrolimus following topical application of tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2009 Mar;160(3):665-9. doi: 10.1111/j.1365-2133.2008.08974.x. Epub 2008 Dec 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Link to Results on JAPIC - enter 140602 in the JapicCTI-RNo. field