Unique ID issued by UMIN | UMIN000037692 |
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Receipt number | R000042989 |
Scientific Title | Evaluation of the anti-wrinkle effect of a intradermal thumbtack type micro-needle: a randomized, double-blind, placebo-controlled trial |
Date of disclosure of the study information | 2019/08/16 |
Last modified on | 2021/03/12 09:38:50 |
Evaluation of the anti-wrinkle effect of a intradermal thumbtack type micro-needle: a randomized, double-blind, placebo-controlled trial
Evaluation of the anti-wrinkle effect of a intradermal thumbtack type micro-needle
Evaluation of the anti-wrinkle effect of a intradermal thumbtack type micro-needle: a randomized, double-blind, placebo-controlled trial
Evaluation of the anti-wrinkle effect of a intradermal thumbtack type micro-needle
Japan |
wrinkle
Dermatology | Aesthetic surgery |
Others
NO
The objective of this study is to verify the evaluation of the anti-wrinkle effect and safety when skin care with scattered needling method using a of a intradermal thumbtack type needle as a solid micro needle.
Safety,Efficacy
evaluation of wrinkles (JCSS)
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Placebo
2
Treatment
Device,equipment | Maneuver |
Skincare with scattered needling method using a intradermal thumbtack type micro-needle (pyonex 0.3mm)
Skincare with scattered needling method using a placebo-needle (PY placebo)
20 | years-old | <= |
Not applicable |
Male and Female
Healthy men and women with wrinkles (1 to 3 wrinkle grades).
Without an exclusion criterion, and a person who can comply with the prohibitions.
1. Take skincare treatments that affect the test site during the study participation period.
2. Ingest or use external preparations, medicines and supplements intended to improve wrinkles during study participation period.
3. It is exposed to excessive ultraviolet rays, such as swimming, mountain climbing, sunbathing, exercise outdoors.
1. Those who have a history of allergies to cosmetics and metals.
2. Those who are receiving "hormone replacement therapy".
3. Those who are pregnant and nursing.
4. Those who have experience in cosmetic care to affect the test site.
5. Those who deemed inappropriate for this study by the investigator.
45
1st name | Shogo |
Middle name | |
Last name | Miyazaki |
Teikyo Heisei University
Faculty of Health Care
1708445
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
03-5843-3111
s.miyazaki@thu.ac.jp
1st name | Shogo |
Middle name | |
Last name | Miyazaki |
Teikyo Heisei University
Faculty of Health Care
1708445
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
03-5843-3111
s.miyazaki@thu.ac.jp
Teikyo Heisei University
Teikyo Heisei University
Other
Teikyo Heisei University
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
03-5843-3111
rec@thu.ac.jp
NO
2019 | Year | 08 | Month | 16 | Day |
http://jsam.jp/
Published
http://jsam.jp/
25
A 2-week skin care program consisting of scattered needling with a intradermal thumbtack needle immediately followed by essence application was effective in reducing fine wrinkles in about 70% of the participants, although with slight pain, with the pain percentage about three times higher than that experienced in essence application alone.
2021 | Year | 03 | Month | 12 | Day |
25 healthy men and women with wrinkles (1 to 3 wrinkle grades).
Eligible participants were dynamically assigned to the intervention group (n=13) or the control group (n=12).
Adverse events in the intervention group were pruritus (n=4), pain (n=3), discomfort at the acupuncture site (n=3), and fatigue (n=1). The mean pain score was 1.0 (SD: 0.7) in the intervention group and 0.3 (SD: 0.5) in the control group (P=0.01).
In the intervention group, efficacy was demonstrated in 9 (69%) participants including 4 with "improvement" and 5 with "reduction," while 3 (25%) participants achieved "reduction" in the control group, showing a risk ratio of 2.8 (95% confidence interval: 1.0-7.9, P=0.03).
Main results already published
2019 | Year | 08 | Month | 05 | Day |
2019 | Year | 04 | Month | 15 | Day |
2019 | Year | 08 | Month | 15 | Day |
2019 | Year | 12 | Month | 18 | Day |
2019 | Year | 08 | Month | 15 | Day |
2021 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042989
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