Status:
COMPLETED
12-Week Efficacy Clinical Study of Serum
Lead Sponsor:
ChinaNorm
Conditions:
Anti-aging
Female
Eligibility:
FEMALE
25-55 years
Phase:
NA
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 su...
Eligibility Criteria
Inclusion
- Chinese women aged from 25-55 years old.
- All skin types, including 50% sensitive skin.
- Regular users of serum with anti-aging need.
- Self-claim concerns of skin quality problem (radiance, smoothness, pore) and aging problems (fine lines, wrinkles, elasticity).
- 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)
- Clinical grading of skin pores, skin radiance and skin smoothness: 4≤grade≤6 evaluated by dermatologist.
- No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
- In general good health at the time of the study.
- Willing and able to participate as evidenced by signing of informed consent and photo release form.
- 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
- Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- Subject deprived of rights by a court or administrative order.
- Major subject to a guardianship order.
- Subject residing in a health or social care establishment.
- Patient in an emergency setting.
- Subject with a skin disease in the test areas (particularly e.g., acne, rosacea, eczema).
- Subject presenting a stable or progressive serious disease (per investigator's assessment).
- Immuno-compromised subject.
- Subject with history of allergy to cosmetic or personal care products or ingredients.
- Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- Subjects regularly practicing aquatic or nautical sports.
- Subjects regularly attending a sauna.
- Subject with cardiovascular or circulatory history.
- Subject with a history of skin cancer or malignant melanoma.
- Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06968416
Start Date
August 2 2023
End Date
November 17 2023
Last Update
May 13 2025
Active Locations (1)
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1
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, China, 200072