Unique ID issued by UMIN | UMIN000038645 |
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Receipt number | R000044033 |
Scientific Title | Randomized, placebo-controlled, double-blind, split-face comparative study on the skin improvement effects of the cosmetic containing collagen-modified liposomes after wounds healing |
Date of disclosure of the study information | 2019/12/01 |
Last modified on | 2020/05/22 18:37:14 |
Study on the skin improvement effects of the cosmetic containing collagen-modified liposomes
KNO-001 study
Randomized, placebo-controlled, double-blind, split-face comparative study on the skin improvement effects of the cosmetic containing collagen-modified liposomes after wounds healing
KNO-001 study
Japan |
Healthy adult women scheduled to complete skin laser treatment
Aesthetic surgery |
Others
NO
Skin improvement effects of the cosmetic containing collagen-modified liposomes after wounds healing, and other skin effects including safety
Efficacy
Confirmatory
Not applicable
Measurement of skin moisture (test site):
Evaluation is made before application of the test product or placebo, 1 week, 2 weeks, 4 weeks and 6 weeks after the start of application of the test product or placebo.
Skin moisture measurement (1 cheek site of each split face)
Evaluation of skin findings by doctors
Analysis of changes in skin conditions using digital camera images
Participant questionnaire
Incidence of adverse events
Skin moisture measurement and analysis of digital camera images are evaluated before application of the test product or placebo, 1 week, 2 weeks, 4 weeks, and 6 weeks after application of the test product or placebo.
The skin findings are evaluated 1 week, 2 weeks, 4 weeks and 6 weeks after the start of application of the test product or placebo.
The questionnaire for the participants will be evaluated 2 weeks, 4 weeks and 6 weeks after the start of application of the test product or placebo.
In addition, safety will be checked throughout the period.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Other |
Apply the test product (skin cosmetic containing a cosmetic base consisting of collagen-modified liposomes) twice a day, and apply an appropriate amount for 6 weeks after wounds healing (after epithelial recovery) following laser treatment.
Apply the placebo, that is the skin cosmetic from which the constituents of the cosmetic base 'collagen modified liposome' are removed from the test product, twice a day, and apply an appropriate amount for 6 weeks after wounds healing (after epithelial recovery) following laser treatment.
20 | years-old | <= |
60 | years-old | >= |
Female
(1) Women who can obtain written consent
(2) Women who are between 20 and 60 years old when obtaining consent
(3) Women with laser treatment target sites on both the left and right sides of the face
(4) Women who can go to the hospital according to the study schedule
(1) Persons with histories of allergies to cosmetic
(2) Person receiving any hormone replacement therapies
(3) Pregnant and breastfeeding women
(4) Persons who have experience in cosmetic medicine that affects the evaluation site, or who are scheduled to receive it during the study period
(5) Persons who have undergone special skin care (e.g., beauty salon, esthetic salon) for the evaluation site within the past 4 weeks or who are scheduled to receive it during the study period
(6) Persons with inflammation or skin disease that affects evaluation
(7) Persons who are judged to be inappropriate for participation in this study by the principal investigator or other investigators (hereinafter referred to as the investigators)
30
1st name | Akira |
Middle name | |
Last name | Takeda |
Kitasato University, school of medicine
Department of Plastic & Aesthetic Surgery
252-0374
1-15-1 Kitasato, Minami-ku, Sagamihara-city, Kanagawa
042-778-9074
takeda@kitasato-u.ac.jp
1st name | Yoshika |
Middle name | |
Last name | Sugimoto |
Kitasato University, school of medicine
Department of Plastic & Aesthetic Surgery
252-0374
1-15-1 Kitasato, Minami-ku, Sagamihara-city, Kanagawa
042-778-9074
yoshika_sgy@yahoo.co.jp
Kitasato University, school of medicine,
Department of Plastic & Aesthetic Surgery
Faith Co., Ltd.
Profit organization
Kitasato University, school of medicine, Institutional Review Board for Clinical Research and Treatment
1-15-1Kitasato,Minami-ku,Sagamihara-city,Kanagawa
042-778-8111
rinrib@med.kitasato-u.ac.jp
NO
北里大学病院(神奈川県)/ Kitasato University Hospital (Kanagawa)
2019 | Year | 12 | Month | 01 | Day |
Unpublished
33
Completed
2019 | Year | 10 | Month | 15 | Day |
2020 | Year | 02 | Month | 07 | Day |
2020 | Year | 02 | Month | 27 | Day |
2020 | Year | 04 | Month | 28 | Day |
2019 | Year | 11 | Month | 20 | Day |
2020 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044033
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