UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004442 |
|---|---|
| Receipt number | R000005317 |
| Scientific Title | Examination of combination and maintenance therapy with Adapalene Gel 0.1% for acne vulgaris |
| Date of disclosure of the study information | 2010/10/26 |
| Last modified on | 2012/06/21 13:16:27 |
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Basic information
Public title
Examination of combination and maintenance therapy with Adapalene Gel 0.1% for acne vulgaris
Acronym
Examination of combination and maintenance therapy with Adapalene Gel 0.1% for acne vulgaris
Scientific Title
Examination of combination and maintenance therapy with Adapalene Gel 0.1% for acne vulgaris
Scientific Title:Acronym
Examination of combination and maintenance therapy with Adapalene Gel 0.1% for 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 of combination and maintenance therapy with Adapalene Gel 0.1% and topical antibiotics or oral antibiotics for the treatment of acne vulgaris in Japan patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(Study-1)Percent reduction in total lesion (inflammatory lesion + comedone) counts of acne vulgaris on the face(inflammatory lesion + comedone)
(Study-2)Period until increasing of inflammatory lesion
Key secondary outcomes
*Change in QOL
*Overall clinical evaluation(after study1)
*Safety
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 considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(Study-1)Group A:Nadifloxacin will be applied for 12 weeks.
Interventions/Control_2
(Study-1)Group B:Adapalene gel 0.1% and Nadifloxacin will be applied for 12 weeks.
Interventions/Control_3
(Study-1)Group C:Adapalene gel 0.1% and Roxithromycin or Nadifloxacin will be applied for totally 12 weeks.
Interventions/Control_4
(Study-2)Grop D:After study-1,Adapalene gel 0.1% will be applied for 12 weeks.
Interventions/Control_5
(Study-2)Group E:After study-1,non-treatment for 12weeks.
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 who has inflammatory lesion
2)Patients who agreeded with their written informed consent
Key exclusion criteria
1) Patients taking some medications (orally,topically, or injective agents, or chemical treatments) expected to be effective to acne vulgaris within one month before the registration of this research.
2) Patients with hypersensitivity to any of the study drugs
3) Patients continuously receiving non-steroidal anti-inflammatory drugs(ibuprofen,etc)
4) Women who are pregnant,might be pregnant or lactating or planning a pregnancy
5) Patients who are considered to be unsuitable for this study by the investigator
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Kawashima |
Organization
Tokyo Woman's Medical University
Division name
Dermatology
Zip code
Address
8-1 Kawada-cho,Shinjyuku-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 | 10 | Month | 26 | 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 | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | 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 | 10 | Month | 26 | Day |
Last modified on
| 2012 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005317
