UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pharmacokinetic study of active ingredient in hair restorer.
Title of the study (Brief title)	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	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chief of Clinic
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	Reiko Maruya
Organization	SOUKEN CO.,LTD
Division name	Secretariat
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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