UMIN-CTR Clinical Trial

Basic information
Public title	Effect of hair growth KB001
Acronym	Effect of hair growth KB001
Scientific Title	Effect of hair growth KB001
Scientific Title:Acronym	Effect of hair growth KB001
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of hair growth KB001
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall improvement level
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply hair growth KB001 for 24 weeks.
Interventions/Control_2	Apply positive control for 24 weeks.
Interventions/Control_3	Apply placebo for 24 weeks.
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 Japanese males aged 20 to 60 years old 2 Subjects who are concerned about Androgenic alopecia
Key exclusion criteria	1 Subjects who have other disease except for Androgenic alopecia 2 Subjects who allergy history on scalp
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Zip code	105-0013
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	1st name Ko Middle name Last name Masuda
Organization	SOUKEN Co., Ltd
Division name	Management Division
Zip code	105-0013
Address	DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
Institute
Department

Funding Source
Organization	Kobayashi Pharmaceutical Co., Ltd.
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	Shiba Palace Clinic Ethics Review Committee
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel	03-5408-1599
Email	shiba_palace@s-palace-clinic.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

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 31 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	90
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	No longer recruiting
Date of protocol fixation	2019 Year 10 Month 01 Day
Date of IRB	2019 Year 10 Month 24 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 17 Day
Last modified on	2020 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044327