Assessment of Dermatopharmaokinetics (DPK) of Tacrolimus -Ethnicity Comparative Study in Japanese and Caucasians

Not Applicable

• Conditions: atopic dermatitis

• Registration Number: JPRN-UMIN000022399
• Lead Sponsor: SOUSEIKAI Hakata Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-23
• Study Completion: 2017-04-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

1. Those who have or have had history of hepatic, renal, cardiovascular, gastrointestinal, or hematological diseases that are considered not to be appropriate to participate in the research. 2. Those who have a history of Atopic Dermatitis. 3. Those who have/ had any skin infectious disease. 4. Those who have a history of drug abuse or alcohol addiction. 5. Those who have a history of allergies to any medication. 6. Those who have a history of food allergies of any kind. 7. Those who have a history of Contact Dermatitis such as dermatitis caused by medical adhesives or Mechanic Urticaria. 8. Those who have a history of cutaneous hypersensitivity to any external preparations, cosmetics, or quasi drugs. 9. Those who have a history of hypersensitivity to PROTOPIC(r) ointment. 10. Those who have a history of Photodermatosis 11. Those who have a history of metal allergies of any kind. 12. Those who were determined to be not eligible to participate in this research by the Principal Investigator or sub-investigator based on their vital sign assessments. 13. Those who have any abnormal findings such as eczema, dermatitis, pigment anomaly, inflammation due to sun burn, wounds, or scars. 14. Those who have taken any medication including OTC drugs within 7 days before the day of study drug application or who have a need to use any medicine including OTC drugs during the study period. 15. Those who have participated in a study involving SC sampling within 1.5 months before the application of study drug. 16. Those who were determined to be ineligible to participate in this research by the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of Tacrolimus in the stratum corneum.

Secondary Outcome Measures

Name	Time	Method
Trans epidermal water loss Safety