Distribution of Tacrolimus in Skin, Atopic Dermatitis

NCT00534508 | Completed Phase 2

• 1 other identifier: FG-506-06-30
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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%.

Conditions

Dermatitis, Atopic

Keywords

Skin; Pharmacokinetics; Tacrolimus; dermatitis, atopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Tacrolimus Ointment 0.1% DRUG

Twice daily, 14 days treatment

Also known as: Protopic 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Dublin, Ireland

Location

Related Publications (2)

• 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.

  PMID: 19076975 BACKGROUND

• Reitamo S, Mandelin J, Rubins A, Remitz A, Makela 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.

  PMID: 19335418 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Central Contact

  Astellas Pharma GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 26, 2007
• Study Start: December 1, 2000
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

IE (1)