UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049818 |
|---|---|
| Receipt number | R000056743 |
| Scientific Title | Exploratory study on the effect of continuous application of cosmetics on skin barrier function and safety in healthy adults with a atopic background |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/12/20 09:55:57 |
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Basic information
Public title
Exploratory study on the effect of continuous application of cosmetics on skin barrier function and safety in healthy adults with a atopic background
Acronym
Exploratory study on the effect of continuous application of cosmetics on skin barrier function and safety in healthy adults with a atopic background
Scientific Title
Exploratory study on the effect of continuous application of cosmetics on skin barrier function and safety in healthy adults with a atopic background
Scientific Title:Acronym
Exploratory study on the effect of continuous application of cosmetics on skin barrier function and safety in healthy adults with a atopic background
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effects of continuous application of the test product on improving skin barrier function and on safety in an exploratory manner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal water loss
Water content in stratum corneum
Amino acid content in stratum corneum
Filaggrin content in stratum corneum
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The placebo emulsion is applied to one of the left and right forearms and the test emulsion to the other for 6 weeks.
Interventions/Control_2
The placebo emulsion is applied to one of the left and right forearms and the test emulsion to the other for 6 weeks.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
More than 20 years old and under 60 when obtaining consent
Applicant must have been fully informed about the study, the person who has the ability to consent, understand the study well, and voluntarily agree to participate in the study in writing.
Persons who has atopic background (history of atopic dermatitis or family history of atopic dermatitis)
Persons who do not habitually apply prescription drugs to the test site (forearm)
Persons who do not routinely clean test site (forearm) with a firm body-washing device (e.g. nylon towel or brush).
Persons who are judged by the principal investigator to be safe to participate in the study based on the results of pre-application testing
Key exclusion criteria
1 Person with symptoms of atopic dermatitis (Judged by skin findings, blood TARC level, and nonspecific IgE level)
2 Person who are at risk of developing symptoms of seasonal hay fever during the study period
3 Person with a history of serious diseases of the glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system, or psychiatric disorders
4 Person with a history of hypersensitivity to cosmetics or who may exhibit allergic symptoms
5 Person with a history of allergy to adhesive tape, medical tape, or rubber
6 Person who smokes habitually
7 Person with past surgical history on test site (forearm)
8 Persons with body hair that may interfere with the evaluation at the test site (forearm application site)
9 Person who has excessive sunburn on the test site at the time of obtaining consent
10 Person who shaves, epilates, or removes hair from the study site (forearm application site) during the study period
11 Person who had cosmetic procedures or treatments (e.g. peeling or laser treatment) on the test site (forearm application site)
12 Person who works night shifts and day/night shifts
13 Person with a history of alcohol and drug dependence
14 Person who is undergoing treatment (hormone replacement therapy, medication, exercise therapy, diet therapy, etc.) at a medical institution for the treatment or prevention of disease, or who are judged to be in need of such treatment at the time of obtaining consent
15 Breastfeeding, pregnant, with likelihood for pregnancy, planning for pregnancy
16 Person who has participated in any other clinical study (any study for using cosmetics, foods, drugs, medical devices, etc.) within the past 4 weeks, or who is scheduled to participate in any other clinical study during the scheduled period of this study.
17 Person who is judged to be inappropriate by investigator and subinvestigators
Target sample size
25
Research contact person
Name of lead principal investigator
| 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
aoki.akihiro@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
DRC株式会社
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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
25
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 10 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056743
