atopic dermatitis
Conditions
Interventions
8 application sites (circles with diameters of 2.5 cm) are allocated on subject'
s back (4 sites each for left and right side of the back), and 10uL of either 0.1 % Tacrolimus(r) '
NP'
ointment or 0.1% Protopic(r) ointment are applied for each site.The application times for each site are 2, 4, 6, and 12 hours for each drug. After pre-scheduled application time, stratum corneum is c
ointment and 0.1% Protopic(r) ointment are applied on left and right side of the back, respectively, in 4 Japanese subjects.
Arm 2: 0.1% Protopic(r) ointment and 0.1 % Tacrolimus(r) '
ointment are applied on left and right side of the back, respectively, in 4 Japanese subjects.
Arm 3: 0.1 % Tacrolimus(r) '
ointment and 0.1% Protopic(r) ointment are applied on left and right side of the back, respectively, in 4 Caucasian subjects.
Arm 4: 0.1% Protopic(r) ointment and 0.1 % Tacrolimus(r) '
ointment are applied on left and right side of the back, respectively, in 4 Caucasian subjects.
Sponsors
SOUSEIKAI Hakata Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects who are aged between 20 and 35 (exclusive) years old, at the time of Informed Consent. 2. Subjects who have a BMI (Body Mass Index) between 18.5 and 25.0 (exclusive) for Japanese and between 18.5 and 30.0 (exclusive) for Caucasians. 3. Japanese: Subjects whose biological parents and grandparents are Japanese. Caucasians: Subjects whose biological parents and grandparents are Caucasian.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of Tacrolimus in the stratum corneum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Trans epidermal water loss Safety | — |
Countries
Japan
Contacts
Public ContactHinako Uchimaru
SOUSEIKAI Hakata Clinic Planning & Coordination Dept.
Outcome results
None listed