UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030502
Receipt No. R000034820
Scientific Title Effective confirmation examination for the beauty effect of HB300
Date of disclosure of the study information 2018/01/09
Last modified on 2019/06/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effective confirmation examination for the beauty effect of HB300
Acronym Effective confirmation examination for the beauty effect of HB300
Scientific Title Effective confirmation examination for the beauty effect of HB300
Scientific Title:Acronym Effective confirmation examination for the beauty effect of HB300
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the esthetic effect of the HB300 treatment to a face for healthy females.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of facial skin color, state of the blood, and facial skin appearance at week 0, 2, and 4 of consecutive facial HB300 treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Applying HB300 on facial skin once a day for 16 days in four weeks.
Interventions/Control_2 No treatment
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
30 years-old <=
Age-upper limit
59 years-old >=
Gender Female
Key inclusion criteria 1. The person who feels that a face is not an impression youthful well recently.
2. The person who is worried about the dullness and uneven coloring of cheeks.
3. The person who feels that eyes are smaller than the past.
Key exclusion criteria 1. Individuals who have some skin troubles and diseases.
2. Individuals who are use drug medicine regularly.
3. Individuals who are pregnant or breastfeeding.
4. Current smoker
5. Individuals who had a diagnosis of blepharoptosis.
6. Individuals who did sunburn more than the everyday life within one month before this examination.
7. Individuals who have received medical cosmetic treatment on their faces.
8. Individuals who put on eyelash extensions.
9. Individuals who are judged as unsuitable for the study by investigator.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Mizushima
Organization Kao Corporation
Division name Skin Care Products Research Laboratory
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL +81-3-5630-9580
Email mizushima.hiroki@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Hosokawa
Organization Kao Corporation
Division name Skin Care Products Research Laboratory
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL +81-3-5630-7286
Homepage URL
Email hosokawa.masaru@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 花王株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 09 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
2017 Year 11 Month 21 Day
Date of IRB
2017 Year 11 Month 21 Day
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2018 Year 03 Month 24 Day
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 21 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034820

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.