|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
27 May 2013 |
|
Main ID: |
JPRN-UMIN000003415 |
|
Date of registration:
|
31/03/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
2010/02/01 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.umin.ac.jp/ctr/index.htm |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
Japan |
|
Telephone:
|
hiramatsu@ebms.co.jp |
|
Email:
|
hiramatsu@ebms.co.jp |
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
Japan |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
EBMs Co.,Ltd Clinical Business Division |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1) Patients with acne vulgaris expressing from moderate to severe symptoms in guideline
2) Patients who gave their written informed consent
Exclusion criteria: 1) Patients taking some drugs(oral,topical or injective agents)expected to be indicated for the treatment of acne within 4 weeks
2) Patients with hypersensitivity to any of the study drugs
3) Patients continuously receiving non-steroidal anti-inflammatory drugs
4) Women who are pregnant,might be pregnant or lactating
5) Patients who are considered unsuitable for this study by the investigator
Age minimum:
16years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
acne vulgaris
|
|
Intervention(s)
|
Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 weeks. In the first 2 weeks, Faropenem Sodium Hydrate will be also administered three times daily.
Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 weeks. In parallel with this treatment, Faropenem Sodium Hydrate will be also administered three times daily for 4 weeks.
Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 weeks.
|
|
Primary Outcome(s)
|
|
Decrease percentage of the number of inflammatory lesion.
|
|
Secondary Outcome(s)
|
-Change of the number of inflammatory lesion and comedone
-Safety
-Change in patient QOL(Skindex-16)
|
|
Source(s) of Monetary Support
|
|
Non-Profit Organization Health Institute Research of Skin
|
|