UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044574
Receipt number R000050917
Scientific Title Efficacy Confirmation Test of Hair Growth and Nurturing Composition (HGT) in Continuous Use
Date of disclosure of the study information 2021/07/12
Last modified on 2022/03/25 13:26:46

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Basic information

Public title

Efficacy Confirmation Test of Hair Growth and Nurturing Composition (HGT) in Continuous Use

Acronym

RHG01

Scientific Title

Efficacy Confirmation Test of Hair Growth and Nurturing Composition (HGT) in Continuous Use

Scientific Title:Acronym

RHG01

Region

Japan


Condition

Condition

thinning hair

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1


To study the effectiveness of the hair growth agent HGT (containing carrot extract, soy protein hydrolysate, and seaweed extract) for women with thinning hair.
To study the effectiveness of the hair growth agent HGT (containing carrot extract, soy protein hydrolysate, and seaweed extract)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percent change in hair diameter after 24 weeks of treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Use hair growth products (active) twice daily for up to 24 weeks. Phototrichograms will be performed prior to dosing, after 12 weeks of dosing, and after 24 weeks of dosing.

Interventions/Control_2

Use hair growth products (placebo) twice daily for up to 24 weeks. Phototrichograms will be performed prior to dosing, after 12 weeks of dosing, and after 24 weeks of dosing.

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

40 years-old <=

Age-upper limit

70 years-old >=

Gender

Female

Key inclusion criteria

(1) Japanese between the ages of 40 and 70 years old
(2) Women with thinning hair equivalent to Ludwig Scale I-2 to II-2 as of the date of consent.
(3) The purpose and content of the study will be explained to the research subjects prior to the study, and the research subjects themselves are capable of making decisions and have given their written consent.

Key exclusion criteria

(1) Those who have hair transplants or wear wigs.
(2) Those who may show allergic symptoms to the components of the test substance.
(3) Those who may show allergic symptoms to the test substance or those who have skin hypersensitivity.
Those who have a history of serious heart disease, renal disease, liver disease, cancer, or thyroid dysfunction.
(5) Those who have not used health foods, cosmetics, quasi-drugs, or medicines (e.g., hair growth products) that may affect the test results for more than 6 months.
(6) Women who are pregnant or may become pregnant, and women who are breastfeeding.
(7) Others whom the principal investigator deems inappropriate to be included in the study.

Target sample size

68


Research contact person

Name of lead principal investigator

1st name Akio
Middle name
Last name Sato

Organization

TMC Medical Corporation Tokyo Memorial Clinic

Division name

board chairman

Zip code

151-0053

Address

16-7, Yoyogi 2-chome, Shibuya-ku, Tokyo

TEL

03-5351-0309

Email

drsato@crux.ocn.ne.jp


Public contact

Name of contact person

1st name Hiromu
Middle name
Last name Katsuta

Organization

ReLife-inc

Division name

Clinical Development Division

Zip code

170-0013

Address

5F Koshin Building, 1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo

TEL

03-5928-2501

Homepage URL


Email

hkatsuta@relife-inc.com


Sponsor or person

Institute

ROHTO Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

ROHTO Pharmaceutical Co., Ltd.

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

ReLife-inc

Address

5F Koshin Building, 1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo

Tel

03-5928-2501

Email

hkatsuta@relife-inc.com


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

医療法人社団TMC 東京メモリアルクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 07 Month 12 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

67

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

2021 Year 06 Month 03 Day

Date of IRB

2021 Year 06 Month 17 Day

Anticipated trial start date

2021 Year 07 Month 12 Day

Last follow-up date

2022 Year 03 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 17 Day

Last modified on

2022 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050917


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name