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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 safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monopolar radiofrequency | Device | Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global aesthetic improvement scale (GAIS) score | Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse). | at day 90 after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Global aesthetic improvement scale (GAIS) score | Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse). | at 30, 60 days after procedure |
| Improvement of skin glossiness |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Subjects were not included in the study if they met any of the following exclusion criteria:
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| SkinCeuticals A.G.E and Skinceuticals CE FERULIC | Other | Test Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC |
|
| Standard Cream | Other | Control Side applies Standard Cream |
|
Skin glossiness was assessed by an independent investigator on both sides of the face (three measurements averaged) according to DermaLab ® Combo (Multipurpose Skin Detector, Cortex) + Chromaticity Test Probe |
| at 30, 60, 90 days after procedure |
| Improvement in skin elasticity and tightness | Skin elasticity was assessed by an independent investigator on both sides of the face (averaged over three measurements) according to the DermaLab ® Combo + Elastic Probe | at 30, 60, 90 days after procedure |
| Improvement in dermal thickness/density | Dermal thickness/density was assessed on both sides of the face (averaged over three measurements) by an independent investigator using the DermaLab ® Combo + HF ultrasound probe | at 30, 60, 90 days after procedure |
| Improvement of transepidermal water loss (TEWL) | TEWL was assessed by an independent investigator on both sides of the face (three measurements averaged) according to the DermaLab ® Combo + TEWL test probe | at 30, 60, 90 days after procedure |
| Improvement of skin stratum corneum water content | Skin stratum corneum moisture was assessed on both sides of the face (three measurements averaged) by an independent investigator using the DermaLab ® Combo + Moisture Testing Probe | at 30, 60, 90 days after procedure |
| Improvement 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 days after procedure |
| Subject satisfaction evaluation | Subject Satisfaction Assessment Form. 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 days after procedure |