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Anti-agingNCT06968416

12-Week Efficacy Clinical Study of Serum

A study testing Standard cleanser，standard moisturizer，standard sunscreen，Investigational serum in people with Anti-aging and Female, run by ChinaNorm at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Anti-aging, Female
What is being tested?
Standard cleanser，standard moisturizer，standard sunscreen，Investigational serum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteChina
Study dates
2 Aug 2023to 17 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200072

Other trials in China

About this study

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.

Conditions
Anti-aging, Female
Being tested
Standard cleanser，standard moisturizer，standard sunscreen，Investigational serum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard cleanser，standard moisturizer，standard sunscreen，Investigational serumOther

    Products Application and Usage Instruction

    1. 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
    2. 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).

Study groups in NCT06968416
Study groupRoleWhat they receive
Group SerumOther65 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.
Receives: Other: Standard cleanser，standard moisturizer，standard sunscreen，Investigational serum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time effect of skin smoothness (Visual)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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 (9)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

  8. Time effect of thickness of epidermis by UC22

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start2 Aug 2023
  3. Primary completion17 Nov 2023
  4. Study completion17 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06968416
Sponsor's protocol ID
C23005030
Status last verified
May 2025
First submitted
21 Apr 2025
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Standard cleanser，standard moisturizer，standard sunscreen，Investigational serum in people with Anti-aging and Female, run by ChinaNorm at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06968416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

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