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

Y

Yes Skin Medical Group

Status

Not yet enrolling

Conditions

Skin Aging

Treatments

Device: monopolar radiofrequency
Other: SkinCeuticals A.G.E and Skinceuticals CE FERULIC
Other: Standard Cream

Study type

Interventional

Funder types

Other

Identifiers

NCT06228833
SKCRFAGE002

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

Female

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Test group
Experimental group
Treatment:
Other: SkinCeuticals A.G.E and Skinceuticals CE FERULIC
Device: monopolar radiofrequency
Control group
Active Comparator group
Treatment:
Other: Standard Cream
Device: monopolar radiofrequency

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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