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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental |
| |
| Control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SkinCeuticals A.G.E | Other | Ultrasound therapy combined with SkinCeuticals A.G.E + conventional moisturizing and sunscreen. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hang Zhou YesSkin Hospital | Recruiting | Hangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40635529 | Derived | 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. |
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| standard cream | Other | Ultrasound therapy combined with standard cream + conventional moisturizing and sunscreen |
|
| 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 |