Distribution of Tacrolimus in Skin, Atopic Dermatitis

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: September 21, 2007
Last updated: September 17, 2014
Last verified: September 2014
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 2

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:

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:
    Drug: Tacrolimus Ointment 0.1%
    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.

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

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

Dublin, Ireland
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Central Contact Astellas Pharma GmbH
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00534508     History of Changes
Other Study ID Numbers: FG-506-06-30 
Study First Received: September 21, 2007
Last Updated: September 17, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Astellas Pharma Inc:
dermatitis, atopic

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 04, 2016