UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the efficiency of Keishibukuryogankayokuinin on acne vulgaris.
Title of the study (Brief title)	The study of the efficiency of Keishibukuryogankayokuinin on acne vulgaris.
Region	Japan

Condition
Condition	Acne vulgaris
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficiency of Keishibukuryogankayokuinin in acne patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The decrement of inflammatory of acne lesions The decrement of non-inflammatory of acne lesions Patients QOL(SKINDEX-16,Syndromes presenting indefinite complaints) Patients satisfaction(Visual analog scale)
Key secondary outcomes

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	The treatment with medicine for external use with Oral Administration of keishibukuryogankayokuinin(2.5g t.i.d before meals)for 12 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	Not applicable
Gender	Female
Key inclusion criteria	1)Patients who have inflammatory of acne lesions more than 6 counts on one side of their faces. 2)Patients for whom oral administration was possible. 3)Patients who agreed with their written informed consent
Key exclusion criteria	1)Patients with serious complications (liver,kidney,heart,blood,or metabolic disorders) 2)Steroid acne,Drug-induced acne, Necrotizing acne, Occupational acne. 3)Patients who administrated steroid drugs on their whole body. 4)Women who are pregnant, might be pregnamt or lactating or planning a pregnancy. 5)Patients who received drugs prohibited for concomitant use within 1 week before the registration of this study. 6)Patients who participated in clinical trial within 1 month before the registration of this study. 7)Patients taking or planning chemical treatment or laser treatment in this study period. 8)Patients with history of hypersensitivity to traditional Japanese medicine. 9)Patients considered inappropriate by the study investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Toshitatsu Nogita
Organization	Shinjuku Minamiguchi Dermatology Skin Clinic
Division name	Director
Address	1-18-7 Nishishinjyuku Shinjyuku-ku Tokyo, Japan
TEL	03-3343-4103
Email	nogita@hifuka.com

Public contact
Name of contact person	Toshitatsu Nogita
Organization	Shinjuku Minamiguchi Dermatology Skin Clinic
Division name	Director
Address	1-18-7 Nishishinjyuku Shinjyuku-ku Tokyo, Japan
TEL	03-3343-4103
Homepage URL
Email	nogita@hifuka.com

Sponsor
Institute	Shinjuku Minamiguchi Dermatology Skin Clinic
Institute
Department

Funding Source
Organization	TSUMURA & CO.
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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 21 Day
Anticipated trial start date	2015 Year 01 Month 05 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 12 Month 19 Day
Last modified on	2016 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018605