Skin Aging
Conditions
Brief 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 safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines
Interventions
DEVICEmonopolar radiofrequency
Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face
OTHERSkinCeuticals A.G.E and Skinceuticals CE FERULIC
Test Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC
OTHERStandard Cream
Control Side applies Standard Cream
Sponsors
Yes Skin Medical Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must meet all of the following criteria to be enrolled in the study: 1. Healthy women, skin quality is not limited, aged 25 \ 65 years old face old \ moderate aging group; 2. subjects facial skin rough, loose, lack of elasticity; 3. Subjects with multiple facial fine lines, decree lines or puppet lines areas have static fine lines trend, the lower part showed signs of loosening; 4. Subjects with consistent facial skin status on both sides and planning to receive monopolar radiofrequency treatment; 5. Be able to cooperate well with the tester and maintain the regularity of life during the study; 6. Be able to read and understand all contents of the informed consent form, and voluntarily sign the informed consent form (ICF); 7. Agreed not to use any cosmetics, drugs and health products that have an impact on the results during the trial;
Exclusion criteria
* Subjects were not included in the study if they met any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global aesthetic improvement scale （GAIS） score | at day 90 after procedure | Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global aesthetic improvement scale （GAIS） score | at 30, 60 days after procedure | Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse). |
| Improvement in skin elasticity and tightness | at 30, 60, 90 days after procedure | 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 |
| Improvement in dermal thickness/density | at 30, 60, 90 days after procedure | 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 |
| Improvement of skin glossiness | at 30, 60, 90 days after procedure | 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 |
| Improvement of skin stratum corneum water content | at 30, 60, 90 days after procedure | 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 |
| Improvement in fine lines score | at 30, 60, 90 days after procedure | 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. |
| Subject satisfaction evaluation | at 30, 60, 90 days after procedure | 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 |
| Improvement of transepidermal water loss (TEWL) | at 30, 60, 90 days after procedure | TEWL was assessed by an independent investigator on both sides of the face (three measurements averaged) according to the DermaLab ® Combo + TEWL test probe |
Outcome results
None listed