Skin AgingNCT05748470
A Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging
A study testing SkinCeuticals A.G.E and standard cream in people with Skin Aging, run by Yes Skin Medical Group at 1 site in China.
Trial summary
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of ultrasound therapy combined with SkinCeuticals A.G.E in improving facial aging, and to explore the medical value of ultrasound therapy… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- SkinCeuticals A.G.E and standard cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to 30 Oct 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese subjects aged 18-65 years inclusive;
- The subject 's facial skin is rough, flaccid, and lack of elasticity;
- Subjects with multiple facial fine lines (perioral/periocular/forehead, etc.), decree lines or puppet lines area with static fine lines trend, the lower part showed signs of loosening;
- Subjects who have consistent facial skin status on both sides and plan to receive ultrasound therapy;
- Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
- Subjects understand the nature of the study and sign the informed consent form (ICF).
Who cannot join
- Subjects with contraindications to ultrasound treatment (such as malignant tumor, acute systemic infection, severe heart disease, bleeding tendency, etc.) or contraindications to A.G.E use (or allergic to other skin care components);
- Subjects with facial skin diseases, infection, inflammation or allergic constitution that may affect the judgment of the test results;
- Subjects with hypertrophic scar or scar constitution;
- Receiving treatment of tightening medical treatment program (Thermage/Fotona 4D/ultrasound/microneedle, etc.) or planning to receive other tightening medical treatment program and drugs during this treatment in the past 3 months;
- Patients who have oral or topical cosmetic products that may affect the test results within the past 2 weeks;
- Subjects who have participated in drug clinical trials or other trials within the past 30 days (or are participating in), or have used drugs affecting the test results within 1 week;
- Female subjects who are pregnant, lactating or plan to become pregnant;
- Other subjects who are not suitable for participating in this study as assessed by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hang Zhou YesSkin Hospital
Hangzhou
Weimin Song, +8613588189292, drsong@yesskin.cn
About this study
Official title: A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging in Real World Clinical Practice
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of ultrasound therapy combined with SkinCeuticals A.G.E in improving facial aging, and to explore the medical value of ultrasound therapy combined with SkinCeuticals A.G.E. Participants will be treated with ultrasound combined with SkinCeuticals A.G.E on one randomized side face and ultrasound combined with standard cream on the other side.
- Conditions
- Skin Aging
- Being tested
- SkinCeuticals A.G.E, standard cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinCeuticals A.G.EOther
Ultrasound therapy combined with SkinCeuticals A.G.E + conventional moisturizing and sunscreen.
standard creamOther
Ultrasound therapy combined with standard cream + conventional moisturizing and sunscreen
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: SkinCeuticals A.G.E |
| Control group | Active comparator | Not described Receives: Other: standard cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global aesthetic improvement scale （GAIS） score
Investigator Satisfaction Assessment Form. Scoring criteria: 5 (very much improved), 4 (marked improvement), 3 (improved), 2 (no change), or 1 (worse).
Measured: at day 90 after procedure
Secondary outcomes (7)
Change from baseline in fine lines score
Skin Parameter Assessment Form. Fine lines: Grading was performed on a Griffith 's scale (10-point scale) with different scores representing: 0 (no fine lines/wrinkles, skin completely smooth and no wrinkles); 1-3 (mild, few fine lines and wrinkles, and distant intervals within the treatment area); 4-6 (moderate, moderate number of fine lines/wrinkles within the treatment area and close to each other); and 7-9 (severe, dense clusters of fine lines/wrinkles within the treatment area). Fine lines status should be evaluated by an independent investigator.
Measured: at 30, 60, 90, 180 days after procedure
Relative change from baseline in skin elasticity
Measured: at 30, 60, 90, 180 days after procedure
Relative change from baseline in dermal thickness
Measured: at 30, 60, 90, 180 days after procedure
Relative change in transepidermal water loss(TEWL) from baseline
Measured: at 30, 60, 90, 180 days after procedure
Investigator satisfaction assessment
Investigator Satisfaction Assessment Form. Questions included: 1. Integrated skincare effect of ultrasonic program. 2, Feeling overall improvement of facial wrinkles after using the product. 3, Feeling that the elasticity of facial skin is improved after using the product. 4, Feeling that facial skin fullness improved after using the product. 5. Feeling that the skin moisture is improved after using the product. Satisfaction ratings were divided into: 1: very dissatisfied, 2: dissatisfied, 3: fair, 4: satisfied, and 5: very satisfied, and the proportion of people in each rating was statistically summarized
Measured: at 30, 60, 90, 180 days after surgery
Subject satisfaction evaluation
Subject Satisfaction Assessment Form. Questions included: 1. Integrated skincare effect of ultrasonic program. 2, Feeling overall improvement of facial wrinkles after using the product. 3, Feeling that the elasticity of facial skin is improved after using the product. 4, Feeling that facial skin fullness improved after using the product. 5. Feeling that the skin moisture is improved after using the product. Satisfaction ratings were divided into: 1: very dissatisfied, 2: dissatisfied, 3: fair, 4: satisfied, and 5: very satisfied, and the proportion of people in each rating was statistically summarized
Measured: at 30, 60, 90, 180 days after procedure
Global aesthetic improvement scale （GAIS） score
Investigator Satisfaction Assessment Form. Scoring criteria: 5 (very much improved), 4 (marked improvement), 3 (improved), 2 (no change), or 1 (worse).
Measured: at day 30,60,180 after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start28 Mar 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yes Skin Medical Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748470
- Sponsor's protocol ID
- WSong
- Status last verified
- Apr 2023
- First submitted
- 3 Feb 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang X, Peng S, Chen Y, Nan Y, Song W. A Randomized, Investigator-Blinded, Split-Face, Controlled Trial Evaluating the Efficacy and Satisfaction of a Topical Product Containing Blueberry Extract and Pro-Xylane Combined With Micro-Focused Ultrasound for Anti-aging. J Cosmet Dermatol. 2025 Jul;24(7):e70281. doi: 10.1111/jocd.70281.
PubMed 40635529
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging in Real World Clinical Practice
- ClinicalTrials.gov ID
- NCT05748470
- Acronym / sponsor ID
- WSong
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yes Skin Medical GroupUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of ultrasound therapy combined with SkinCeuticals A.G.E in improving facial aging, and to explore the medical value of ultrasound therapy combined with SkinCeuticals A.G.E. Participants will be treated with ultrasound combined with SkinCeuticals A.G.E on one randomized side face and ultrasound combined with standard cream on the other side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: SkinCeuticals A.G.E |
| Control group | Active comparator | Other: standard cream |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chinese subjects aged 18-65 years inclusive;
- The subject 's facial skin is rough, flaccid, and lack of elasticity;
- Subjects with multiple facial fine lines (perioral/periocular/forehead, etc.), decree lines or puppet lines area with static fine lines trend, the lower part showed signs of loosening;
- Subjects who have consistent facial skin status on both sides and plan to receive ultrasound therapy;
- Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
Key exclusion criteria (8 listed)
- Subjects with contraindications to ultrasound treatment (such as malignant tumor, acute systemic infection, severe heart disease, bleeding tendency, etc.) or contraindications to A.G.E use (or allergic to other skin care components);
- Subjects with facial skin diseases, infection, inflammation or allergic constitution that may affect the judgment of the test results;
- Subjects with hypertrophic scar or scar constitution;
- Receiving treatment of tightening medical treatment program (Thermage/Fotona 4D/ultrasound/microneedle, etc.) or planning to receive other tightening medical treatment program and drugs during this treatment in the past 3 months;
- Patients who have oral or topical cosmetic products that may affect the test results within the past 2 weeks;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkinCeuticals A.G.EUltrasound therapy combined with SkinCeuticals A.G.E + conventional moisturizing and sunscreen. | Other | Test group |
| standard creamUltrasound therapy combined with standard cream + conventional moisturizing and sunscreen | Other | Control group |
Primary outcome
Global aesthetic improvement scale （GAIS） score
Time frame: at day 90 after procedure
Investigator Satisfaction Assessment Form. Scoring criteria: 5 (very much improved), 4 (marked improvement), 3 (improved), 2 (no change), or 1 (worse).
7 secondary outcomes
Change from baseline in fine lines score
Time frame: at 30, 60, 90, 180 days after procedure
Relative change from baseline in skin elasticity
Time frame: at 30, 60, 90, 180 days after procedure
Relative change from baseline in dermal thickness
Time frame: at 30, 60, 90, 180 days after procedure
Relative change in transepidermal water loss(TEWL) from baseline
Time frame: at 30, 60, 90, 180 days after procedure
Investigator satisfaction assessment
Time frame: at 30, 60, 90, 180 days after surgery
Subject satisfaction evaluation
Time frame: at 30, 60, 90, 180 days after procedure
Global aesthetic improvement scale （GAIS） score
Time frame: at day 30,60,180 after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 40635529Jiang X, Peng S, Chen Y, Nan Y, Song W. A Randomized, Investigator-Blinded, Split-Face, Controlled Trial Evaluating the Efficacy and Satisfaction of a Topical Product Containing Blueberry Extract and Pro-Xylane Combined With Micro-Focused Ultrasound for Anti-aging. J Cosmet Dermatol. 2025 Jul;24(7):e70281. doi: 10.1111/jocd.70281.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkinCeuticals A.G.E and standard cream in people with Skin Aging, run by Yes Skin Medical Group 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global aesthetic improvement scale （GAIS） score (time frame: at day 90 after procedure). 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 NCT05748470, which also lists 1 linked publication.
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 19 Apr 2023.