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

Skin Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06228833
• Other study ID #: SKCRFAGE002
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: January 2024
• Source: Yes Skin Medical Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Aging

Intervention

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
• Standard Cream
Control Side applies Standard Cream

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yes Skin Medical Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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