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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032919
Receipt No. R000036598
Scientific Title Skin pigmentation in acne vulgaris patients A study on usefulness of vitamin C gel
Date of disclosure of the study information 2018/06/10
Last modified on 2019/03/12

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Basic information
Public title Skin pigmentation in acne vulgaris patients
A study on usefulness of vitamin C gel
Acronym A study on usefulness of vitamin C gel
Scientific Title Skin pigmentation in acne vulgaris patients
A study on usefulness of vitamin C gel
Scientific Title:Acronym A study on usefulness of vitamin C gel
Region
Japan

Condition
Condition Acne valgaris patients
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the usefulness of vitamin C gels in skin pigmentation of acne vulgaris
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of post-inflammatory pigmentation(PIH):4 weeks after treatment starts, 8weeks, 12 weeks evaluation of improvement by 'investigator's global improvement rating' in each observation period
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 After washing the test product twice a day, in the morning and before bedtime, apply the appropriate amount to the affected area (pigmentation site) every day for 12 weeks.
Interventions/Control_2
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
16 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Patients with pigmentation symptoms of acne vulgaris
Key exclusion criteria 1)Patients with experience of skin symptoms such as contact dermatitis by the components and similar components of this research.

2)A patient with an inappropriate rash or other lesion in the affected area.

3)Patients with unstable symptoms of disease and complications that cause pigmentation.

4)Patients undergoing treatment for pigmentation or patients who have not been over one year since the end of treatment.

5)Pregnant, possibely pregnant, hope to be pregnant, or breastfeeding woman.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kurokawa
Middle name
Last name Ichiro
Organization Meiwa Hospital, Medical Corporation
Division name Department of Dermatology
Zip code 6638186
Address 4-31 Naruo-machi, Nishinomiya-shi, Hyogo
TEL 0789-47-1767
Email kurokawa.i@meiwa-hospital.com

Public contact
Name of contact person
1st name Ogaki
Middle name
Last name Yoshitaka
Organization EBC&M LLC.
Division name Business Promotion Department
Zip code 1050011
Address TOWER FRONT KAMIYACHO 5F,1-3-8,Higashiazabu,Minato-ku Tokyo 106-0044 Japan
TEL 03-6435-3833
Homepage URL
Email yoshitaka_ogaki@ebc-m.com

Sponsor
Institute Meiwa Hospital, Medical Corporation
Institute
Department

Funding Source
Organization Meiwa Hospital, Medical Corporation
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 Japan Conference of Clinical Reserarch IRB
Address 2-27-1, MinamiIkebukuro, Toshima-ku,Tokyo
Tel 03-6868-7022
Email nakagawa-kengo@cts-smo.com

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
2018 Year 06 Month 10 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 35
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
2017 Year 11 Month 07 Day
Date of IRB
2018 Year 03 Month 22 Day
Anticipated trial start date
2018 Year 03 Month 26 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 02 Month 10 Day
Date trial data considered complete
2019 Year 03 Month 10 Day
Date analysis concluded
2019 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 08 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036598

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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