UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038756 |
|---|---|
| Receipt number | 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 14:54:50 |
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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
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
aoki.akihiro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044187
