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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023689
Receipt No. R000027283
Scientific Title A pharmacokinetic study of active ingredient in hair restorer.
Date of disclosure of the study information 2016/08/20
Last modified on 2018/05/24

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Basic information
Public title A pharmacokinetic study of active ingredient in hair restorer.
Acronym A pharmacokinetic study of active ingredient in hair restorer.
Scientific Title A pharmacokinetic study of active ingredient in hair restorer.
Scientific Title:Acronym A pharmacokinetic study of active ingredient in hair restorer.
Region
Japan

Condition
Condition alopecia prematura
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the active ingredient kinetics in blood and urine after administration of hair restorer.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetic parameter of active ingredient in hair restorer calculated from the concentration of blood concentration before administration and 1,2,4,6,8,12,24,48hrs after, and urinary concentration before administration and 2,4,6,8,12,24hrs after.
Key secondary outcomes 1)Photographs of occipital and parietal region scalp.
2)Results of blood chemical analysis and skin surface topography before administration.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Administration of commercial hair restorer on scalp twice at an interval of 2 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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
60 years-old >
Gender Male
Key inclusion criteria 1) Mail patients with alopecia premature (typeVI or early- or mid-stage of typeII and typeIV in Ogata's classification)
2) Patients with 60-75kg body weight.
3) Non-smoker
4) Patients with negative in viral test,
5) Patients without problem in health especially in metabolic function.
Key exclusion criteria 1) Patients taking or using medicine which can have influence on the result.
2) Patients having daily health food which can have influence on the result.
3) Patients who is capable to have allergic responses to constituent parts of test articles.
4) Patients participating in other clinical tests.
5) Patients with any histories of hepatic disorder,nephropathy,heart disease,dysuria.
6) Patients with alopecia other than alopecia premature or unexplained alopecia.
7) Patients with rapid hair loss or patchy alopecia
8) Patients with wound or eczema or inflammation on scalp
9) Patients with allergic responses to any drug or cosmetic.
10) Patients treated for hypotension or hypertension.
11) Patients with systolic pressure under 100mmHg or above 160mmHg.
12) Patients with diastolic pressure above 110mmHg.
13) Patients with swelling.
14) Patients with thyroid dysfunction.
15) Patients with arrhythmia and severe anemia.
16) Patients using anticoagulant.
17) Patients with subjective symptoms of anemia.
18) Patients whose blood was collected over 400mL during 3 months or over 200mL during 2 months.
19) Patients treated hair addition or hair transplantation.
20) Patients haven one's hair permed in 1 month.
21) Patients with histories of positives in virus test.
22) Patients met any of following criterias.
-Total cholesterol:280mg/dL or more
-Triglyceride:400 mg/dL or more
-FBG:130 mg/dL or more
-Uric acid:9.0 mg/dL or more
-Creatinine:1.5 mg/dL or more
23) Patients with 2.5 times more than standard value of either g-GT,AST,ALT,direct bilirubin or total bilirubin.
24) Patients deemed inappropriate to participate in this study by the principal investigator or sub-investigators.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chief of Clinic
Zip code
Address Daiwa A Hamamatsu-cho Bldg. 6F, 1-9-10, Hamamatsu-cho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL 03-5408-1599
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Maruya
Organization SOUKEN CO.,LTD
Division name Secretariat
Zip code
Address Hamamatsu-cho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL 03-5733-1555
Homepage URL
Email r_maruya@mail.souken-r.com

Sponsor
Institute SOUKEN CO.,LTD
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 株式会社SOUKEN(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 06 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 05 Month 24 Day
Date analysis concluded
2018 Year 05 Month 24 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 19 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027283

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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