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Completed

NCT Number: NCT06968416

12-Week Efficacy Clinical Study of Serum

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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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai China-norm Quality Technical Service Co., Ltd.

Shanghai, Shanghai Municipality, 200072, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Standard cleanser,standard moisturizer,standard sunscreen,Investigational serum

Other

Products Application and Usage Instruction

  • Mode of application: T-3W ~ T0

Frequency:

AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer Caution: No any other skincare or facial make up products are used except provide products

  • Mode of application: T0 ~ T12W

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).

Primary outcomes

  1. Time effect of skin smoothness (Visual)

    Time frame: 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.

  2. Time effect of skin radiance (Visual)

    Time frame: 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.

  3. Time effect of skin pore (Visual)

    Time frame: 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.

  4. Time effect of skin elasticity (Tactile)

    Time frame: 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.

  5. Time effect of skin firmness (Visual)

    Time frame: 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.

  6. Time effect of forehead wrinkles

    Time frame: Compare to baseline,Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

  7. Time effect of fine lines on the forehead

    Time frame: Compare to baseline,Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

  8. Time effect of glabellar wrinkles

    Time frame: Compare to baseline,Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

  9. Time effect of inter-ocular wrinkles

    Time frame: Compare to baseline,Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

  10. Time effect of crow's feet wrinkles

    Time frame: Compare to baseline,Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

  11. Time effect of underneath eye wrinkles

    Time frame: Compare to baseline,Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

  12. Time effect of cheek folds

    Time frame: Compare to baseline,Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

  13. Time effect of nasolabial fold

    Time frame: Compare to baseline,Time point at 1Week , Time point at 2Week, Time point at 4Week, Time point at 8Week and Time point at 12Week.

  14. Time effect of wrinkles of the corner of the lips

    Time frame: 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

  1. Time effect of count number of forehead wrinkles by Primos

    Time frame: Compare to baseline,Time point at 4Week, Time point at 8Week and Time point at 12Week.

  2. Time effect of total length of forehead wrinkles by Primos

    Time frame: Compare to baseline,Time point at 4Week, Time point at 8Week and Time point at 12Week.

  3. Time effect of area of forehead wrinkles by Primos

    Time frame: Compare to baseline,Time point at 4Week, Time point at 8Week and Time point at 12Week.

  4. Time effect of count number of crow's feet wrinkles by Primos

    Time frame: Compare to baseline,Time point at 4Week, Time point at 8Week and Time point at 12Week.

  5. Time effect of total length of crow's feet wrinkles by Primos

    Time frame: Compare to baseline,Time point at 4Week, Time point at 8Week and Time point at 12Week.

  6. Time effect of area of crow's feet wrinkles by Primos

    Time frame: Compare to baseline,Time point at 4Week, Time point at 8Week and Time point at 12Week.

  7. Time effect of thickness of dermis by UC22

    Time frame: Compare to baseline,Time point at 8Week and Time point at 12Week.

  8. Time effect of thickness of epidermis by UC22

    Time frame: Compare to baseline,Time point at 4Week, Time point at 8Week and Time point at 12Week.

  9. Time effect of thickness of epidermis and dermis by UC22

    Time frame: Compare to baseline,Time point at 4Week, Time point at 8Week and Time point at 12Week.

Sponsors and collaborators

Lead sponsor

ChinaNorm

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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