UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003415 |
|---|---|
| Receipt number | R000004137 |
| Scientific Title | Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris. |
| Date of disclosure of the study information | 2010/03/31 |
| Last modified on | 2011/04/21 17:46:06 |
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Basic information
Public title
Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
Acronym
Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
Scientific Title
Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
Scientific Title:Acronym
Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.
Region
| Japan |
Condition
Condition
acne vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and the best treatment period of combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris in Japanese patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Decrease percentage of the number of inflammatory lesion.
Key secondary outcomes
-Change of the number of inflammatory lesion and comedone
-Safety
-Change in patient QOL(Skindex-16)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
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.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with acne vulgaris expressing from moderate to severe symptoms in guideline
2) Patients who gave their written informed consent
Key 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
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Kawashima/Nobukazu Hayashi |
Organization
Tokyo Woman's Medical University
Division name
Dermatology
Zip code
Address
8-1 Kawada-cho Shinjuku-ku, Tokyo 162-8666, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
EBMs Co.,Ltd
Division name
Clinical Business Division
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Tokyo Woman's Medical University
Institute
Department
Personal name
Funding Source
Organization
Non-Profit Organization Health Institute Research of Skin
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 03 | Month | 31 | 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
| 2010 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 31 | Day |
Last modified on
| 2011 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004137
