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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038756
Receipt No. R000044187
Scientific Title Effect of combined topical application of cosmetic gel and emulsion on skin biophysical characteristics: a randomized single-blind trial
Date of disclosure of the study information 2020/01/10
Last modified on 2020/06/02

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Basic information
Public title Effect of combined topical application of cosmetic gel and emulsion on skin biophysical characteristics: a randomized single-blind trial
Acronym Effect of combined topical application of cosmetic gel and emulsion on skin biophysical characteristics: a randomized single-blind trial
Scientific Title Effect of combined topical application of cosmetic gel and emulsion on skin biophysical characteristics: a randomized single-blind trial
Scientific Title:Acronym Effect of combined topical application of cosmetic gel and emulsion on skin biophysical characteristics: a randomized single-blind trial
Region
Japan

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

Objectives
Narrative objectives1 To examine whether the combined topical application of both cosmetic gel and emulsion has an advantage on the potency of skin biophysical characteristics, compared to application of only cosmetic emulsion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of skin biophysical characteristics
(stratum corneum hydration, viscoelasticity, skin color, pigmented spots, corneocyte surface area)
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 For 8 weeks, application of cosmetic gel plus emulsion to which one side of face and only emulsion to which the other side
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
30 years-old <=
Age-upper limit
59 years-old >=
Gender Female
Key inclusion criteria 1.More than 30 years old and under 60 when obtaining consent
2.Feel dry for skin
3.Person who is judged to be medically normal by investigator and subinvestigators based on results of examination before application of cosmetic
Key exclusion criteria 1.Habitually apply topical preparation, medicine and supplement likely affecting test sites (cosmetic for skin whitening, oral contraceptives etc.) when obtaining consent
2.Atopic dermatitis
3.Deeply suntanned when obtaining consent
4.Difference more than twice water content value between test sites (both cheeks)in screening
5.Person with past surgical history on test sites
6.History of allergy or oversensitivity when applies medicine and cosmetic
7.Smoker including person who has stopped smoking within 60 days prior to consent date
8.Not expected to follow the rules determined in this study
9.Person who has enrolled in other clinical study
10.Pregnant, with likelihood for pregnancy, planning for pregnancy
, Breastfeeding
11.Take hormone replacement therapy
12.Person who is judged to be inappropriate by investigator and subinvestigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kosaburo
Middle name
Last name Wakamatsu
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Otsu Skin Care Research Institute
Zip code 5200002
Address 3-31-13 Saigawa, Otsu, Shiga
TEL 077-521-8835
Email wakamatsu.kosaburo@otsuka.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Aoki
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Otsu Skin Care Research Institute
Zip code 5200002
Address 3-31-13 Saigawa, Otsu, Shiga
TEL 077-521-8835
Homepage URL
Email aoki.akihiro@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Brain Care Clinic Ethics Review Committee
Address Samon-Cho 13, Isobe Bidg.2F, Shinjuku-ku, Tokyo
Tel 06-6882-1130
Email ethics_board@drc-web.co.jp

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
2020 Year 01 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 33
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason under monitoring
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
2019 Year 11 Month 07 Day
Date of IRB
2019 Year 11 Month 01 Day
Anticipated trial start date
2019 Year 12 Month 26 Day
Last follow-up date
2020 Year 03 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 02 Day
Last modified on
2020 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044187

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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