UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014831
Receipt number R000017237
Scientific Title The study of the efficiency and the safety of keigairengyoto(TJ-50) on acne vulgaris.
Date of disclosure of the study information 2014/08/11
Last modified on 2017/05/15 15:38:46

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The study of the efficiency and the safety of keigairengyoto(TJ-50) on acne vulgaris.

Acronym

The effect of keigairengyoto(TJ-50) on acne vulgaris.

Scientific Title

The study of the efficiency and the safety of keigairengyoto(TJ-50) on acne vulgaris.

Scientific Title:Acronym

The effect of keigairengyoto(TJ-50) 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 and safety of keigairengyoto 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
*Skindex-16
*Patients satisfaction(Visual analog scale)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A: The treatment with medicine for external use (Adapalen and Nadifloxacine or Clindamycine) for 12 weeks

Interventions/Control_2

Group B: The treatment with medicine for external use (Adapalen and Nadifloxacine or Clindamycine) with Oral Administration of keigairengyoto (2.5g t.i.d before meals) for 12 weeks

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

15 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients who have inflammatory of acne lesions on 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) Women who are pregnant,might be pregnamt or lactating or planning a pregnancy
3) Patients who received drugs prohibited for concomitant use within 1 week before the registration of this study
4) Patients who participated in clinical trial within 1 month before the registration of this study
5) Patients taking or planning chemical treatment or laser treatment in this study period
6) Patients with history of hypersensitivity to traditional Japanese medicine
7) Patients considered inappropriate by the study investigator

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Imafuku

Organization

Faculty of Medicine Fukuoka University

Division name

Department of Dermatology

Zip code


Address

7-45-1 Nanakuma, Jyonan-ku, Fukuoka-city, Fukuoka, Japan

TEL

092-801-1011

Email

dermatologist@mac.com


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Imafuku

Organization

Faculty of Medicine Fukuoka University

Division name

Department of Dermatology

Zip code


Address

7-45-1 Nanakuma, Jyonan-ku, Fukuoka-city, Fukuoka, Japan

TEL

092-801-1011

Homepage URL


Email

dermatologist@mac.com


Sponsor or person

Institute

Faculty of Medicine Fukuoka University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 08 Month 11 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


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

2014 Year 07 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 08 Month 11 Day

Last modified on

2017 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017237


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name