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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032931
Receipt No. R000037508
Official scientific title of the study Objective Evaluation of Acne Scar by Three-Dimensional Image Analysis Using Antera 3D.
Date of disclosure of the study information 2018/06/12
Last modified on 2018/06/08

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Basic information
Official scientific title of the study Objective Evaluation of Acne Scar by Three-Dimensional Image Analysis Using Antera 3D.
Title of the study (Brief title) Objective Evaluation of Acne Scar by Three-Dimensional Image Analysis Using Antera 3D.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether three-dimensional image analysis using Antera 3D is an evaluation method for simply and objectively evaluating acne scar.
Basic objectives2 Others
Basic objectives -Others Usefulness of image analysis
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between evaluation of acne scar by dermatologists and evaluation of acne scar using Antera 3D
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Individuals who is over 20 years old at the time of informed consent.
2) Regardless of gender
3) Individuals with one or more acne scars (atrophic scars) on the cheeks.
4) Individuals who obtained the written consent to participate in the study after explanation of the details of the study and understanding it sufficiently.
Key exclusion criteria 1) Individuals with a history of diseases, etc. that may affect the evaluation.
2) Individuals with comorbid illnesses that may affect evaluation.
3) Individuals judged inappropriate for the study.
Target sample size 20

Research contact person
Name of lead principal investigator Yuki Yamashita
Organization Nikoderm Research Inc.
Division name Evaluation Division
Address 1-6-14, Azuchimachi, Chuoku, Osaka, Japan
TEL 06-6125-3501
Email yamashita@nikoderm.com

Public contact
Name of contact person Yuki Yamashita
Organization Nikoderm Research Inc.
Division name Evaluation Division
Address 1-6-14, Azuchimachi, Chuoku, Osaka, Japan
TEL 06-6125-3501
Homepage URL
Email yamashita@nikoderm.com

Sponsor
Institute Nikoderm Research Inc.
Institute
Department

Funding Source
Organization Maruho Co.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 12 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 04 Month 27 Day
Anticipated trial start date
2018 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Objective evaluation methods of acne scar are needed to evaluate the effectiveness of acne scar treatments.

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037508

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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