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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Skin Aging
• Intervention / Treatment: Device: monopolar radiofrequency; Other: SkinCeuticals A.G.E and Skinceuticals CE FERULIC; Other: Standard Cream

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 exclusion criteria:

  1. 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);
  2. Subjects with facial skin diseases, infections, inflammation, etc. that may affect the judgment of the test results;
  3. Subjects with hypertrophic scar or scar constitution;
  4. Subjects who have experienced tightening medical treatment (Gemma, Fotona 4D, ultrasonic cannon, ultrasonic scalpel, gold microneedle, etc.) in the past 3 months;
  5. Subjects who have oral and topical cosmetic products that may affect the study results within 2 weeks;
  6. 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;
  7. Pregnant or lactating women, or recent plans to prepare for pregnancy;
  8. Other subjects who are not suitable for participating in this study as assessed by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Device: monopolar radiofrequency; Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face; Other: Standard Cream; Control Side applies Standard Cream
Experimental: Test group	Device: monopolar radiofrequency; Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face; Other: SkinCeuticals A.G.E and Skinceuticals CE FERULIC; Test Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Yes Skin Medical Group

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2024
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SKCRFAGE002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No