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

NCT ID: NCT06228833

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2024-10-30

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

Conditions

Skin Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test group

Group Type: EXPERIMENTAL

monopolar radiofrequency

Intervention Type: DEVICE

Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face

SkinCeuticals A.G.E and Skinceuticals CE FERULIC

Intervention Type: OTHER

Test Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC

Control group

Group Type: ACTIVE_COMPARATOR

monopolar radiofrequency

Intervention Type: DEVICE

Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face

Standard Cream

Intervention Type: OTHER

Control Side applies Standard Cream

Interventions

monopolar radiofrequency

Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face

Intervention Type: DEVICE

SkinCeuticals A.G.E and Skinceuticals CE FERULIC

Test Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC

Intervention Type: OTHER

Standard Cream

Control Side applies Standard Cream

Intervention Type: OTHER

Eligibility Criteria

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

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yes Skin Medical Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SKCRFAGE002

Identifier Type: -

Identifier Source: org_study_id