A Clinical Study 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
- Conditions
- Skin Aging
- Interventions
- Device: monopolar radiofrequencyOther: Standard CreamOther: SkinCeuticals A.G.E and Skinceuticals CE FERULIC
- Registration Number
- NCT06228833
- Lead Sponsor
- Yes Skin Medical Group
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
-
Subjects must meet all of the following criteria to be enrolled in the study:
- Healthy women, skin quality is not limited, aged 25 ~ 65 years old face old ~ moderate aging group;
- subjects facial skin rough, loose, lack of elasticity;
- Subjects with multiple facial fine lines, decree lines or puppet lines areas have static fine lines trend, the lower part showed signs of loosening;
- Subjects with consistent facial skin status on both sides and planning to receive monopolar radiofrequency treatment;
- Be able to cooperate well with the tester and maintain the regularity of life during the study;
- Be able to read and understand all contents of the informed consent form, and voluntarily sign the informed consent form (ICF);
- Agreed not to use any cosmetics, drugs and health products that have an impact on the results during the trial;
-
Subjects were not included in the study if they met any of the following exclusion criteria:
- Subjects with contraindications to monopolar radiofrequency treatment (such as malignant tumors, acute systemic infection, metal implants or active implants in the body such as cardiac pacemakers/defibrillators, etc.) or contraindications to A.G.E./CE use (or allergies to other skin care components);
- Subjects with facial skin diseases, infections, inflammation, etc. that may affect the judgment of the test results;
- Subjects with hypertrophic scar or scar constitution;
- Subjects who have experienced tightening medical treatment (Gemma, Fotona 4D, ultrasonic cannon, ultrasonic scalpel, gold microneedle, etc.) in the past 3 months;
- Subjects who have oral and topical cosmetic products that may affect the study results within 2 weeks;
- Subjects who participate in drug clinical trials or other trials within 30 days, or subjects who have systemic use of drugs that may affect the study results within the past 1 week;
- Pregnant or lactating women, or recent plans to prepare for pregnancy;
- Other subjects who are not suitable for participating in this study as assessed by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group monopolar radiofrequency - Control group monopolar radiofrequency - Control group Standard Cream - Test group SkinCeuticals A.G.E and Skinceuticals CE FERULIC -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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 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
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
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.
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