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65 female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed above. At least 40 subjects should complete the clinical evaluation and 60 subjects should complete consumer questionnaire in this 15-week study (wash-out phase for 3 weeks and treatment phase for 12 weeks). Subjects will need to refrain from using any product other than the provided test products on whole face including eye area during the 3-week wash-out phase and 12-week study treatment phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Serum | Other | 65 female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed below, at least 40 subjects should complete the clinical evaluation and image capture, 60 subjects should complete consumer questionnaire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard cleanser，standard moisturizer，standard sunscreen，Investigational serum | Other | Products Application and Usage Instruction
Frequency: AM: Standard cleanser + Investigational serum (face and eye) [FLA #774715 21] + standard moisturizer + standard sunscreen PM: Standard cleanser + Investigational serum (face and eye) [FLA #774715 21] + standard moisturizer Caution: No any other skincare or facial make up products are used except provide products Usage Instruction： Use serum [FLA #774715 21] 8-10 drops (0.3ml) on cleansed face and eye skin 2 times a day (AM & PM). |
| Measure | Description | Time Frame |
|---|---|---|
| Time effect of skin smoothness (Visual) | Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. | |
| Time effect of skin radiance (Visual) | Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. | |
| Time effect of skin pore (Visual) | Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. | |
| Time effect of skin elasticity (Tactile) | Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. | |
| Time effect of skin firmness (Visual) | Compare to baseline，Time point immediate , Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. | |
| Time effect of forehead wrinkles | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. | |
| Time effect of fine lines on the forehead | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. | |
| Time effect of glabellar wrinkles | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Measure | Description | Time Frame |
|---|---|---|
| Time effect of count number of forehead wrinkles by Primos | Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week. | |
| Time effect of total length of forehead wrinkles by Primos | Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping Xu, Master | Shanghai China-norm Quality Technical Service Co., Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co., Ltd. | Shanghai | Shanghai Municipality | 200072 | China |
This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
18-Month Duration: The data sharing period starts upon PRS registration completion.
Timeline:
Months 1-2: Data de-identification, metadata preparation, and platform integration.
Month 3: Official launch of data access.
Primary Platform:
ResMan (www.medresman.org.cn) - China's leading medical research data repository.
Eligibility:
Researchers/affiliates from academic institutions, hospitals, or registered research organizations.
Engaged in dermatology, cosmetic science, or related fields. Able to demonstrate ethical compliance and data security capabilities.
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| Time effect of inter-ocular wrinkles | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of crow's feet wrinkles | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of underneath eye wrinkles | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of cheek folds | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of nasolabial fold | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of wrinkles of the corner of the lips | Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of area of forehead wrinkles by Primos | Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of count number of crow's feet wrinkles by Primos | Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of total length of crow's feet wrinkles by Primos | Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of area of crow's feet wrinkles by Primos | Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of thickness of dermis by UC22 | Compare to baseline，Time point at 8Week and Time point at 12Week. |
| Time effect of thickness of epidermis by UC22 | Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week. |
| Time effect of thickness of epidermis and dermis by UC22 | Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week. |