A Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Skin Aging

Intervention / Treatment
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* Other: SkinCeuticals A.G.E
* Other: standard cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br> | Other: SkinCeuticals A.G.E<br>* Ultrasound therapy combined with SkinCeuticals A.G.E + conventional moisturizing and sunscreen.<br>|
| Active Comparator: Control group<br> | Other: standard cream<br>* Ultrasound therapy combined with standard cream + conventional moisturizing and sunscreen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at day 90 after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 30, 60, 90, 180 days after procedure | 
| Relative change from baseline in skin elasticity |  | at 30, 60, 90, 180 days after procedure | 
| Relative change from baseline in dermal thickness |  | at 30, 60, 90, 180 days after procedure | 
| Relative change in transepidermal water loss(TEWL) from baseline |  | 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 | 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 | 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). | at day 30,60,180 after procedure |