UMIN-CTR Clinical Trial

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

alopecia prematura

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

SOUKEN CO.,LTD

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

株式会社SOUKEN（東京都）

Date of disclosure of the study information

2016

Year

08

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

08

Month

19

Day

Last modified on

2018

Year

05

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027283