UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000044187