the wrinkles in the corner of the eyes
Conditions
Interventions
During the study period, only the test product is applied to the outer corner of the eye on the side to which the test product is applied. Nothing will be applied to the outer corner of the eyes on th
Sponsors
Japan Bio Products Co.,Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Age 20 or older at the time consent is obtained,59 years of age or younger at the time of consent 2) Wrinkle grade 1 to 3 at the corner of the eyes, mainly on the left and right sides. 3) Skin type III or IV (according to Fitzpatrick's classification)
Exclusion criteria
Exclusion criteria: 1) Those whose left and right eye wrinkle grade scores are markedly different (difference of +/-1.0 or more between left and right eye wrinkle grade) 2) The subject continuously uses skincare products, cosmetics, quasi-drugs, or health foods that claim or emphasize the same or related efficacy (reduction of fine lines and wrinkles due to dryness) as the test product in this study for the evaluation site. 3) Have undergone or plan to undergo cosmetic treatment in the area to be evaluated during the study period. 4) Who have changed or started using health food products or basic cosmetics or sunscreen products for the evaluation site within the past 4 weeks. 5) Who are participating in another study that interferes with this study at the time of study entry or will be participating in another study that interferes with this study during the study's planned duration. 6) Who are undergoing treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) at a medical institution for the treatment or prevention of disease or whose condition is judged to be in need of treatment at the time of consent income. 7) Currently undergoing dermatological treatment. 8) Those who work night shifts or day/night shifts 9) Those with a history of alcohol and drug dependence 10) Persons taking alcohol, vitamin B12, melatonin, or other drugs for sleep. 11) Persons at risk of developing allergies to cosmetics or foods (including those who have developed skin rashes or other skin problems with cosmetics within the past year). 12) Pregnant or lactating mothers at the time of consent, or those who wish to become pregnant during the study period. 13) Persons who were deemed unsuitable for participation in the study by the study supervisor or the study administrator (If the study supervisor or the study administrator became aware of facts that made them ineligible in the course of conducting the study, they were excluded from the analysis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle grade at the corner of the eye Trained Expert skilled in wrinkle evaluation performed 8-level wrinkle grade evaluation based on the evaluation criteria and wrinkle grade photo (*) (twice: before the test and 2 weeks after the test) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of wrinkles by replica analysis (twice: before the study and 2 weeks after the start of the study) Rubber-based precision impression material (hydrophilic vinyl silicone impression material) was applied to an area approximately 5 mm away from the subject's eyes, and skin replicas were made of the target area within this range, 10 x 10 mm or larger. The replicas were analyzed using a replica analysis system to calculate the wrinkle area ratio, wrinkle volume ratio, maximum wrinkle depth, maximum wrinkle width, average wrinkle depth, and number of wrinkles. | — |
Countries
Japan
Contacts
Public ContactTsuyuko Watanabe
Japan Bio Products Co.,Ltd Medical Affairs Division
Outcome results
None listed