UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049159 |
|---|---|
| Receipt number | R000055853 |
| Scientific Title | Research on the effectiveness of S-LEC Solar Control Film L, a heat insulation interlayer film for laminated glass, in reducing thermal sensation induced mainly by near-infrared rays. |
| Date of disclosure of the study information | 2022/10/07 |
| Last modified on | 2024/04/01 14:39:26 |
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Basic information
Public title
Research on the effectiveness of S-LEC Solar Control Film L, a heat insulation interlayer film for laminated glass, in reducing thermal sensation induced mainly by near-infrared rays.
Acronym
Research on the effectiveness of S-LEC Solar Control Film L, a heat insulation interlayer film for laminated glass, in reducing thermal sensation induced mainly by near-infrared rays.
Scientific Title
Research on the effectiveness of S-LEC Solar Control Film L, a heat insulation interlayer film for laminated glass, in reducing thermal sensation induced mainly by near-infrared rays.
Scientific Title:Acronym
Research on the effectiveness of S-LEC Solar Control Film L, a heat insulation interlayer film for laminated glass, in reducing thermal sensation induced mainly by near-infrared rays.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of S-LEC Solar Control Film L, a heat insulation interlayer film for laminated glass, in reducing thermal sensation (burning sensation) induced mainly by near-infrared rays.
Basic objectives2
Others
Basic objectives -Others
Not applicable.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to feel heat sensation (burning sensation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Near-infrared radiation is irradiated to the dorsal surface of the right hand using test sample 1.
Interventions/Control_2
Near-infrared radiation is irradiated to the dorsal surface of the right hand using test sample 2.
Interventions/Control_3
Near-infrared radiation is irradiated to the dorsal surface of the right hand using test sample 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese male and female 18 years or older on the day consent is obtained.
2) Those who understand the research and have given written consent based on their free will.
3)Those who can fill out the consent form, questions, and other documents based on their understanding of the study.
4) Those who can come to the designated facility on the day of the research.
Key exclusion criteria
1) Those with dermatitis, bruises, trauma, or other conditions on the hands and forearms that make them unsuitable for testing.
2) Those whose left and right hands and forearms differ in pain or heat sensitivity.
3) Those with photosensitivity or a history of photosensitivity.
4) Those with subjective symptoms such as heat in the hands and forearms.
5) Those who have perceptual abnormalities, such as hypoesthesia.
6) Those with excessive sunburn.
7) Those receiving medication for pain.
8) Those with a history or complications that may affect the evaluation of this study.
9) Who are participating in other clinical research or clinical trials.
10) Those who are deemed inappropriate by the principal investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kawashima |
Organization
Non-Profit Organization Health Institute
Research of Skin
Division name
Vice Chairman
Zip code
101-0047
Address
Fukuda Building 2F,1-8-9 Uchikanda, Chiyoda-ku, Tokyo
TEL
03-3256-2575
info@npo-hifu.net
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Nomachi |
Organization
EBC&M LLC.
Division name
Project planning and Development department
Zip code
105-0011
Address
Shiba Matsuo Building 4F, 2-9-1 Shibakoen, Minato-ku, Tokyo
TEL
03-6435-3833
Homepage URL
akira_nomachi@ebc-m.com
Sponsor or person
Institute
Non-Profit Organization Health Institute Research of Skin
Institute
Department
Personal name
Funding Source
Organization
SEKISUI CHEMICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Non-Profit Organization Health Institute
Research of Skin
Name of secondary funder(s)
IRB Contact (For public release)
Organization
clinical research review board of the NPO Health Institute research of skin
Address
Fukuda Building 2F,1-8-9 Uchikanda, Chiyoda-ku, Tokyo
Tel
03-3256-2575
info@npo-hifu.net
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
株式会社ビューティアンドヘルスリサーチ
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/epdf/10.1111/jocd.15876
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1111/jocd.15876
Number of participants that the trial has enrolled
49
Results
Results: Laminated glass with S-LEC Solar Control Film L reduced the burning sensation caused by NIR and delayed the onset of the sensation, compared with the control glasses.
Conclusion: The use of S-LEC Solar Control Film L in the laminated glass of vehicles may improve passenger comfort and prevent skin disorders such as photoaging caused by prolonged exposure to NIR.
Results date posted
| 2024 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 01 | Day |
Baseline Characteristics
A total of 49 subjects provided informed consent to participate in the study, and included 22 males and 27 females with a mean age of 43.6 and 41.4 years, respectively.
Participant flow
All 49 participants were included in the analysis.
Adverse events
No adverse events related to the study were observed
Outcome measures
The time (mean( standard deviation)) until the onset of a burning sensation during exposure to NIR for 30 s was 20.0(8.10), 24.0(6.64), and 28.0(4.75) with test products 1, 2, and 3, respectively . The onset time with test product 3 was significantly longer than for test products 1 and 2 (1 vs. 3: p < 0.001, 2 vs. 3: p < 0.01). If the subjects did not feel a burning sensation after 30s exposure, this result was recorded as 30 s. The number of subjects who did not feel a burning sensation throughout the 30s exposure was 14, 20, and 36 for test samples 1, 2, and 3, respectively. The degree of the burning sensation after 30 s exposure to NIR was 4.27(2.85) 3.31(2.80), and 1.20(1.79) with test products 1, 2, and 3, respectively. The degree of the burning sensation with test product 3 was significantly lower than with test products 1 and 2 (1 vs. 3: p < 0.001, 2 vs. 3: p < 0.001).
The degree of the burning sensation with test products 1, 2, and 3 was 3.50(0.60), 2.32(0.57), and 0.68(0.37) in males, and 4.89(0.54), 4.11(0.52), and 1.63(0.34) in females, respectively. The time until the onset of a burning sensation with test products 1, 2, and 3 was 22.6(1.67), 25.0(1.42), and 29.4(0.99) in males, and 17.9(1.50), 23.3(1.28), and 26.9(0.89) in females, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055853
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