NCT06228833Not yet recruitingNot Applicable
A Prospective, Single-center, Single-blind, Randomized Split-face Controlled 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
Yes Skin Medical Group0 sites50 target enrollmentStarted: January 30, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Global aesthetic improvement scale （GAIS） score
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Global aesthetic improvement scale （GAIS） score
Time Frame: 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 Outcomes
- Global aesthetic improvement scale （GAIS） score(at 30, 60 days after procedure)
- Improvement of skin glossiness(at 30, 60, 90 days after procedure)
- Improvement in dermal thickness/density(at 30, 60, 90 days after procedure)
- Subject satisfaction evaluation(at 30, 60, 90 days after procedure)
- Improvement of transepidermal water loss (TEWL)(at 30, 60, 90 days after procedure)
- Improvement in fine lines score(at 30, 60, 90 days after procedure)
- Improvement in skin elasticity and tightness(at 30, 60, 90 days after procedure)
- Improvement of skin stratum corneum water content(at 30, 60, 90 days after procedure)
Investigators
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