UMIN-CTR Clinical Trial

Basic information
Public title	Objective Evaluation of Acne Scar by Three-Dimensional Image Analysis Using Antera 3D.
Acronym	Objective Evaluation of Acne Scar by Three-Dimensional Image Analysis Using Antera 3D.
Scientific Title	Objective Evaluation of Acne Scar by Three-Dimensional Image Analysis Using Antera 3D.
Scientific Title:Acronym	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
Last name of lead principal investigator	1st name Middle name Last name Yuki Yamashita
Organization	Nikoderm Research Inc.
Division name	Evaluation Division
Zip code
Address	1-6-14, Azuchimachi, Chuoku, Osaka, Japan
TEL	06-6125-3501
Email	yamashita@nikoderm.com

Public contact
1st name of contact person	1st name Middle name Last name Yuki Yamashita
Organization	Nikoderm Research Inc.
Division name	Evaluation Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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	2018 Year 04 Month 27 Day
Date of IRB	2018 Year 05 Month 30 Day
Anticipated trial start date	2018 Year 06 Month 13 Day
Last follow-up date	2019 Year 02 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
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	2019 Year 04 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