臨床研究等提出・公開システム

Date of registration	Feb. 08, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220997

Scientific Title	Phase 2 study of RK-023 patients with androgenetic alopecia (male pattern baldness) -A study for safety and preliminary estimation of hair re-growth in male subjects with androgenetic alopecia treated for 13 weeks with RK-023-
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	R-Tec Ueno, Ltd
	Address	http://rtechueno.com/en/contact/index.php
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		48
Study Type		Interventional
Study Design	Study Design	Double-blind, randomised, placebo-controlled study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Men aged between 20 and 44 years with an androgenetic alopecia rated as Takashima modified classification of Norwood-Hamiltonstage, IIv, IIIv and IV
	Exclusion Criteria	Subjects with the complication that treatment is required
	Minimum Age	20age old over
	Maximum Age	44age old under
	Gender	Male
Health Condition or Problem Studied		Androgenetic alopecia (male pattern baldness)
Intervention(s)		investigational material(s) Generic name etc : RK-023 INN of investigational material : Therapeutic category code : 269 Other agents for epidermis Dosage and Administration for Investigational material : Apply 2 mL of the solution to bald area twice a day control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Apply 2 mL of the solution to bald area twice a day
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Number of cases with side-effects (Safety), change for anagen hair ratio (Efficacy) Clinical valuation (Safety) Phototrichogram (Efficacy)
Secondary Outcome		Global photograph of vertex (Efficacy) Global photograph of vertex

Primary Sponsor	R-Tech Ueno, Ltd
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-101030
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Feb. 27, 2013	Detail	Changes
5	Feb. 27, 2013	Detail	Changes
4	Feb. 26, 2013	Detail	Changes
3	Feb. 26, 2013	Detail	Changes
2	Feb. 08, 2010	Detail	Changes
1	Feb. 08, 2010	Detail

List of change history