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 |
The study of the efficiency and the safety of keigairengyoto(TJ-50) on acne vulgaris.
The effect of keigairengyoto(TJ-50) on acne vulgaris.
The study of the efficiency and the safety of keigairengyoto(TJ-50) on acne vulgaris.
The effect of keigairengyoto(TJ-50) on acne vulgaris.
Japan |
Acne vulgaris
Dermatology |
Others
NO
To evaluate efficiency and safety of keigairengyoto in acne patients.
Safety,Efficacy
*The decrement of inflammatory of acne lesions
*The decrement of non-inflammatory of acne lesions
*Skindex-16
*Patients satisfaction(Visual analog scale)
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Group A: The treatment with medicine for external use (Adapalen and Nadifloxacine or Clindamycine) for 12 weeks
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
15 | years-old | <= |
65 | years-old | > |
Male and Female
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
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
64
1st name | |
Middle name | |
Last name | Shinichi Imafuku |
Faculty of Medicine Fukuoka University
Department of Dermatology
7-45-1 Nanakuma, Jyonan-ku, Fukuoka-city, Fukuoka, Japan
092-801-1011
dermatologist@mac.com
1st name | |
Middle name | |
Last name | Shinichi Imafuku |
Faculty of Medicine Fukuoka University
Department of Dermatology
7-45-1 Nanakuma, Jyonan-ku, Fukuoka-city, Fukuoka, Japan
092-801-1011
dermatologist@mac.com
Faculty of Medicine Fukuoka University
TSUMURA & CO.
Profit organization
NO
2014 | Year | 08 | Month | 11 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 31 | Day |
2014 | Year | 08 | Month | 11 | Day |
2014 | Year | 08 | Month | 11 | Day |
2017 | Year | 05 | Month | 15 | Day |
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 |