UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005810 |
|---|---|
| Receipt number | R000006817 |
| Scientific Title | A randomized multi-centered study to prove the effectiveness of combination therapy with topical Nadifloxacin and adapalene gel 0.1% for acne vulgaris |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2011/06/20 13:12:35 |
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Basic information
Public title
A randomized multi-centered study to prove the effectiveness of combination therapy with topical Nadifloxacin and adapalene gel 0.1% for acne vulgaris
Acronym
A randomized multi-centered study to prove the effectiveness of combination therapy with topical Nadifloxacin and adapalene gel 0.1% for acne vulgaris
Scientific Title
A randomized multi-centered study to prove the effectiveness of combination therapy with topical Nadifloxacin and adapalene gel 0.1% for acne vulgaris
Scientific Title:Acronym
A randomized multi-centered study to prove the effectiveness of combination therapy with topical Nadifloxacin and adapalene gel 0.1% for acne vulgaris
Region
| Japan |
Condition
Condition
Acne valgaris patients over 12 years old.
(moderately- severe patients)
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study evaluated the efficacy of combination therapy with topical Nadifloxacinand adapalene gel 0.1% for acne vulgaris compare with an adapalene gel 0.1% alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We examine the decrease rate of the number of inflammatory lesion.
Count inflammatory lesions(Watching) and judgement of photograph.
(take a photo on the one side of the face and fixed the photo place)
Key secondary outcomes
Skin symptoms:erythema,scale,dryness,urtication,itching 4grade
Patients opinionpoll:erythema,scale,dryness,urtication,itching 5grade
Applicate condition:Physical examination
Bacteriologic survey
Safety:survey an adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are 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
1.Design of study
multi-centered,randomization by way of an envelope,2-group comparison study
Interventions/Control_2
1.Design of study
multi-centered,randomization by way of an envelope,2-group comparison study
2.numbers:6 patients
3.Medicine
The drug dosing is assumed to be a usual prescription based on health insurance treatment.
A. Adapalen gel0.1% alone
B.Nadifloxacin1%+Adapalen gel0.1%
4.The way of applocation
A.Adapalene0.1%
Apply adapalene gel 0.1% to the affected area once daily at bedtime for a period of 12 weeks.
B.Nadifloxacin1%+Adapalen gel0.1%
In the morining, apply Nadifloxacin1% only to the affected area, and before asleep,you apply Nadifloxacin1%to the affected area after apply Adapalene0.1%.
5.Ovserved terms:12weeks
(Before,2,4,8,12,dropped out )
6.Assesment
1)inflammatoly lesion counts on the one side of the face(Watching)
2)Judgement of photografh
3)Ovservation of lesion
decrease persentage:>75%=very good,50to<75%=good,25to<50%=usually,<25% or becoming worse=Not good
We assessment in 4grade.
We assessment the lesion (erythema,scale,dry,burning,itching)
about 4 grade(nothing, slightly,moderate,severe)in the ovservation days.
4)How to application is executed by physical examinations.
5)Bacterium test(Only facilities that can be executed)
6)Survey of patients opinion poll
As a use medicine to the experimental medicine, We investigated by the self-assessment method about erythema,dryness,urtication,stimulation,itching in the 5 levels(it feels very much, it feels, it feels a little, it feels slightly, and it doesn't feel it at all)
7)The final efficacy
We examined the clinical change of ski lesions in the final ovservation day:
very effactive,effective,slightly effective,no change,worse,unchanged:5grade
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acne valgaris patients over 12 years old
(moderately - severe)
Key exclusion criteria
Slightly acne,electrical acne, secondary acne,the most severe acne,slightly acne
Patients who taking medicine orally for acne desease.
Pregnant woman and likely to be pregnant or hope to be pregnant.
Patients who weres a mustache
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fukumi Furukawa |
Organization
Wakayama medical univercity
Division name
Department of dermatology
Zip code
Address
811-1kimiidera, wakayama-shi, wakayama-ken
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Wakayama medical univercity
Division name
Department of dermatology
Zip code
Address
811-1kimiidera, wakayama-shi, wakayama-ken
TEL
Homepage URL
Sponsor or person
Institute
Hamamatsu medical univercity
Department of dermatology
Institute
Department
Personal name
Funding Source
Organization
Yukms Co. Ltd.
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
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
| 2011 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 06 | Month | 20 | Day |
Last modified on
| 2011 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006817
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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