UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051270 |
|---|---|
| Receipt number | R000058473 |
| Scientific Title | Evaluation of the protective effect of cosmetics on skin against UV irradiation |
| Date of disclosure of the study information | 2023/06/16 |
| Last modified on | 2023/12/07 14:02:41 |
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Basic information
Public title
Evaluation of the protective effect of cosmetics on skin against UV irradiation
Acronym
Evaluation of the protective effect of cosmetics on skin against UV irradiation
Scientific Title
Evaluation of the protective effect of cosmetics on skin against UV irradiation
Scientific Title:Acronym
Evaluation of the protective effect of cosmetics on skin against UV irradiation
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the protective effect of cosmetics application against UV irradiation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
erythema index
Key secondary outcomes
skin color
Digital Photography
(melanin index)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply test cosmetics (serum) to the designated medial part of the upper arm during 7 days
Interventions/Control_2
Apply placebo cosmetics (serum) to the designated medial part of the upper arm during 7 days
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women between the ages of 20 and 59 at the time of consent
2) Those whose skin is mainly reddish when exposed to the sun and who do not darken afterwards or are less likely to darken than other people around them.
3) Those whose skin color is fair or normal.
4) Those who can agree to have sunburn scars (1cm diameter circle x 6 pieces per row x 1 row on the left upper arm and 3 pieces per row on the right upper arm, maximum of 9 circles) on the inner side of the right and left upper arms for about 6 months (depending on the skin type).
Key exclusion criteria
1) Who are participating in other clinical trials
2) Persons with factors in the medial part of the upper arm of both arms that may affect the results of the test (ex. atopic dermatitis and urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, etc., or their traces).
3) Those who cannot avoid sunburn due to prolonged outdoor work or sports from screening to the end of the test.
4) Those who plan to travel abroad, go swimming, etc. from screening to the end of the test.
5) Those who are undergoing special facial care (e.g., facial appliances, esthetics, peeling, laser treatment, etc.)
6) Those who take medicines, quasi-drugs, or supplements with efficacy for melasma or hyperpigmentation caused by sunburn at least 3 times a week (such as HYTHIOL, HICEE WHITE, TRANSINO Cystina, Alphe, Vitamin C, L-Cysteine)
7) Those who are pregnant, potentially pregnant or lactating
8) Those who are visiting hospital for treatment of an illness or receiving medication
9) Persons who regularly take medications (anti-histamines, anti-inflammatory drugs, painkillers)
10) Persons who may exhibit symptoms of skin allergies or skin hypersensitivity
11) Those who are currently undergoing dermatological treatment
12) Persons who may develop seasonal allergic symptoms such as hay fever during the study period and may use pharmaceuticals
13) Those who develop blisters due to sunburn
14) Those with extremely thin upper arms
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kou |
| Middle name | |
| Last name | Masuda |
Organization
SOUKEN
Division name
Deputy Director
Zip code
105-0013
Address
6F DaiwaA Hamamatucho Bldg., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1555
k_masuda@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Ohkuma |
Organization
Research Center for Immunological Analysis, Inc.
Division name
Director
Zip code
701-1221
Address
ORIC213, 5303, Haga, Kita-Ku, Okayama-shi, Okayama
TEL
08628609333
Homepage URL
a-okuma@menekibunseki.com
Sponsor or person
Institute
SOUKEN
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamada Bee Company, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
6F DaiwaA Hamamatucho Bldg., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2023 | Year | 06 | Month | 16 | 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
| 2023 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2023 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058473
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