Clinical trial NCT06968416: 12-Week Efficacy Clinical Study of Serum
Official title: 12-Week Efficacy Clinical Study of Serum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-aging
Female
Lead sponsor: ChinaNorm
Sponsor class: INDUSTRY
First posted: 2025-05-13
Enrollment: 73
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Chinese women aged from 25-55 years old.
2. All skin types, including 50% sensitive skin.
3. Regular users of serum with anti-aging need.
4. Self-claim concerns of skin quality problem (radiance, smoothness, pore) and aging problems (fine lines, wrinkles, elasticity).
5. Presenting with corresponding severity for the attribute evaluated by Dermatologist： Crows' feet wrinkle (Loreal atlas, 2≤grade≤5) Underneath Eye Wrinkle (Loreal atlas, 2≤grade≤5) Inter Ocular Wrinkles (Loreal atlas, 1\<grade≤4) Glabellar wrinkles (Loreal atlas, 1\<grade≤4) Nasolabial fold (Loreal atlas, 2≤grade≤4) Forehead wrinkle (Loreal atlas, 2≤grade≤5) Fine lines on the forehead (Loreal atlas, 1\<grade≤4) Cheek folds (Loreal atlas, 2≤grade≤5) Wrinkles of the corner of the lips (Loreal atlas, 1\<grade≤4)
6. Clinical grading of skin pores, skin radiance and skin smoothness: 4≤grade≤6 evaluated by dermatologist.
7. No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
8. In general good health at the time of the study.
9. Willing and able to participate as evidenced by signing of informed consent and photo release form.
10. Must be willing to comply with all study protocol requirements (pay attention to: only use the provided product during the study, not take topical or oral treatment like retinol, hormone, anti-oxidant health-care products which may impact the efficacy of study).

Exclusion Criteria:

1. Pregnant or breast-feeding woman or woman planning pregnancy during the study.
2. Subject deprived of rights by a court or administrative order.
3. Major subject to a guardianship order.
4. Subject residing in a health or social care establishment.
5. Patient in an emergency setting.
6. Subject with a skin disease in the test areas (particularly e.g., acne, rosacea, eczema).
7. Subject presenting a stable or progressive serious disease (per investigator's assessment).
8. Immuno-compromised subject.
9. Subject with history of allergy to cosmetic or personal care products or ingredients.
10. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
11. Subjects regularly practicing aquatic or nautical sports.
12. Subjects regularly attending a sauna.
13. Subject with cardiovascular or circulatory history.
14. Subject with a history of skin cancer or malignant melanoma.
15. Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.

Primary outcomes:
measure: Time effect of skin smoothness (Visual)
timeFrame: 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.
measure: Time effect of skin radiance (Visual)
timeFrame: 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.
measure: Time effect of skin pore (Visual)
timeFrame: 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.
measure: Time effect of skin elasticity (Tactile)
timeFrame: 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.
measure: Time effect of skin firmness (Visual)
timeFrame: 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.
measure: Time effect of forehead wrinkles
timeFrame: 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: Time effect of fine lines on the forehead
timeFrame: 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: Time effect of glabellar wrinkles
timeFrame: 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: Time effect of inter-ocular wrinkles
timeFrame: 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: Time effect of crow's feet wrinkles
timeFrame: 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: Time effect of underneath eye wrinkles
timeFrame: 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: Time effect of cheek folds
timeFrame: 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: Time effect of nasolabial fold
timeFrame: 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: Time effect of wrinkles of the corner of the lips
timeFrame: Compare to baseline，Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.
Secondary outcomes:
measure: Time effect of count number of forehead wrinkles by Primos
timeFrame: Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week.
measure: Time effect of total length of forehead wrinkles by Primos
timeFrame: Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week.
measure: Time effect of area of forehead wrinkles by Primos
timeFrame: Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week.
measure: Time effect of count number of crow's feet wrinkles by Primos
timeFrame: Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week.
measure: Time effect of total length of crow's feet wrinkles by Primos
timeFrame: Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week.
measure: Time effect of area of crow's feet wrinkles by Primos
timeFrame: Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week.
measure: Time effect of thickness of dermis by UC22
timeFrame: Compare to baseline，Time point at 8Week and Time point at 12Week.
measure: Time effect of thickness of epidermis by UC22
timeFrame: Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week.
measure: Time effect of thickness of epidermis and dermis by UC22
timeFrame: Compare to baseline，Time point at 4Week, Time point at 8Week and Time point at 12Week.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Quality Technical Service Co., Ltd.
state: Shanghai
Study officials:
affiliation: Shanghai China-norm Quality Technical Service Co., Ltd.
name: Ping Xu, Master
role: PRINCIPAL_INVESTIGATOR
References: