- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07156071
- Original Trial
12-Week Study on the Efficacy of Two Serums in Improving Skin Aging and Tone
12-Week Serum Efficacy Study
This study aims to evaluate the anti-aging and skin tone improvement effects of two facial serums over a 12-week period. It was conducted at a single research center with a 2-week washout period followed by full-face application of the test products for 12 weeks.
A total of at least 120 healthy Chinese female participants aged 18 to 45 were enrolled and divided into two treatment groups:Each group included both early aging (18-29 years) and mature aging (30-45 years) subgroups, with at least 30 participants in each subgroup.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Shanghai, China
- Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chinese female aged 18-45 years (evenly split among Early aging [18-29 years] and Mature aging [30-45 years]).
- All skin types (dry, normal, oily, or mixed).
- Currently experiencing lack of radiance, roughness, dullness, and fine lines or wrinkles on facial skin as self-claimed.
Early aging group (18-29 years): Must present with corresponding severity for the attributes evaluated by Dermatologist, including:
- Skin smoothness, radiance, dullness: grade between 2 and 6 (scale 0-9);
- Size of acne marks (PIH): size ≥ 2;
- Small folds on nasolabial zone: grade between 1 and 3 (Skin Aging Atlas, 0-6 scale, Page 56-57).
Mature aging group (30-45 years): Must present with corresponding severity for the attributes evaluated by Dermatologist, including:
- Skin smoothness, radiance, dullness: grade between 4 and 6 (scale 0-9);
- Small folds on nasolabial zone: grade between 1 and 4 (Skin Aging Atlas, 0-6 scale, Page 56-57);
- Forehead wrinkles: grade ≥ 2 (Skin Aging Atlas, 0-8 scale, Page 32-33);
- Crow's feet wrinkles: grade ≥ 2 (Skin Aging Atlas, 0-6 scale, Page 40-41).
- Regular user of serum and sunscreen products.
- Did not participate in any clinical test or cosmetic product test on skin within the last 3 months.
- No exclusion by dermatologist due to other medical or dermatological reasons.
- 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 (including using only the skincare products provided during the study and not taking topical or oral treatments such as retinol, hormones, or antioxidant health supplements).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Serum 1 Group
Participants in this arm applied Serum 1 (Fla#897183 329) to the full face twice daily for 12 weeks.
The group included both early aging (18-29 years) and mature aging (30-45 years) subgroups.
|
Applied topically on the full face in the morning and evening for 12 weeks during the treatment period.
Used by participants in the Serum 1 group.
|
|
Experimental: Serum 2 Group
Participants in this arm applied Serum 2 (Fla#b50198) to the full face twice daily for 12 weeks.
The group included both early aging (18-29 years) and mature aging (30-45 years) subgroups.
|
Applied topically on the full face in the morning and evening for 12 weeks during the treatment period.
Used by participants in the Serum 2 group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dermatologist-Assessed Wrinkle Attributes
Time Frame: from Baseline to Week 12
|
Crow's feet wrinkles, forehead wrinkles, global wrinkles, small folds on nasolabial zone and global fine lines will be evaluated by dermatologist.
|
from Baseline to Week 12
|
|
Self-assessment Questionnaire
Time Frame: 12 weeks
|
Participants will complete a 5-point self-assessment questionnaire at Timm, T4w, T8w, and T12w, evaluating their perception of skin softness, smoothness, plumpness, elasticity, hydration, oil control, and visible aging signs.
Ratings from 4 to 5 will be used to calculate "Top 2 box" percentage.
|
12 weeks
|
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Change in Dermatologist-Assessed Skin Texture and Quality Attributes
Time Frame: from Baseline to Week 12
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Skin smoothness (visual), skin elasticity, skin softness, skin firmness, skin plumpness, cheek pores will be evaluated by dermatologist.
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from Baseline to Week 12
|
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Change in Dermatologist-Assessed Skin Tone Attributes
Time Frame: from Baseline to Week 12
|
Skin radiance, skin translucency, skin pigmentation, skin fairness, skin tone evenness and skin dullness will be evaluated by dermatologist.
|
from Baseline to Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Skin Hydration Measured by Corneometer
Time Frame: 12 weeks
|
12 weeks
|
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Change in Skin Elasticity Measured by Cutometer
Time Frame: 12 weeks
|
12 weeks
|
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Change in Transepidermal Water Loss (TEWL) Measured by Vapometer
Time Frame: 12 weeks
|
12 weeks
|
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Change in Facial Image-Based Skin Parameters Using VISIA-CR
Time Frame: 12 weeks
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12 weeks
|
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Change in Cheek Skin Surface Condition Using VisioScan VC20
Time Frame: 12 weeks
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12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C23005059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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