12-Week Efficacy Clinical Study of Serum

ChinaNorm

Status: Completed

Conditions: Anti-aging; Female

Treatments: Other: Standard cleanser，standard moisturizer，standard sunscreen，Investigational serum

Study type: Interventional

Funder types: Industry

Identifiers

NCT06968416

C23005030

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

73 participants in 1 patient group

Group Serum

Other group

Description:

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.

Treatment:

Other: Standard cleanser，standard moisturizer，standard sunscreen，Investigational serum