UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022399 |
|---|---|
| Receipt number | R000025818 |
| Scientific Title | Assessment of Dermatopharmaokinetics (DPK) of Tacrolimus -Ethnicity Comparative Study in Japanese and Caucasians |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2017/12/13 15:11:54 |
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Basic information
Public title
Assessment of Dermatopharmaokinetics (DPK) of Tacrolimus -Ethnicity Comparative Study in Japanese and Caucasians
Acronym
Assessment of Dermatopharmaokinetics (DPK) of Tacrolimus
Scientific Title
Assessment of Dermatopharmaokinetics (DPK) of Tacrolimus -Ethnicity Comparative Study in Japanese and Caucasians
Scientific Title:Acronym
Assessment of Dermatopharmaokinetics (DPK) of Tacrolimus
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishing the method of dermal pharmacokinetics (DPK) by assessing the bioavailability of two pharmacokinetically equivalent ointments, 0.1% Tacrolimus(r) ointment 'NP' and 0.1% Protopic(r) ointment, in stratum corneum. Ethnic difference of bioavailability in stratum corneum is also compared in Japanese and Caucasian.
Basic objectives2
Others
Basic objectives -Others
Dermatopharmacokinetics
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of Tacrolimus in the stratum corneum.
Key secondary outcomes
Trans epidermal water loss
Safety
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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 collected by 22 times repeated application and removal of adhesive tape for each site.
Arm 1: 0.1 % Tacrolimus(r) 'NP' ointment and 0.1% Protopic(r) ointment are applied on left and right side of the back, respectively, in 4 Japanese subjects.
Interventions/Control_2
Arm 2: 0.1% Protopic(r) ointment and 0.1 % Tacrolimus(r) 'NP' ointment are applied on left and right side of the back, respectively, in 4 Japanese subjects.
Interventions/Control_3
Arm 3: 0.1 % Tacrolimus(r) 'NP' ointment and 0.1% Protopic(r) ointment are applied on left and right side of the back, respectively, in 4 Caucasian subjects.
Interventions/Control_4
Arm 4: 0.1% Protopic(r) ointment and 0.1 % Tacrolimus(r) 'NP' ointment are applied on left and right side of the back, respectively, in 4 Caucasian subjects.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male
Key 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.
Key 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.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kayo Taira |
Organization
SOUSEIKAI Hakata Clinic
Division name
Clinical Pharmacology Department
Zip code
Address
Random Square (5th-7th floors)6-18 Tenyamachi, Hakata-ku, Fukuoka,812-0025
TEL
0922837701
kayo-taira@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hinako Uchimaru |
Organization
SOUSEIKAI Hakata Clinic
Division name
Planning & Coordination Dept.
Zip code
Address
Random Square (5th-7th floors)6-18 Tenyamachi, Hakata-ku, Fukuoka,812-0025
TEL
0922837701
Homepage URL
hinako-uchimaru@lta-med.com
Sponsor or person
Institute
SOUSEIKAI Hakata Clinic
Institute
Department
Personal name
Funding Source
Organization
SOUSEIKAI Hakata Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 21 | Day |
Last modified on
| 2017 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025818
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
