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

NCT06228833 | Unknown

• 1 other identifier: SKCRFAGE002
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 skin elasticity and tightness

  at 30, 60, 90 days after procedure

• Improvement in dermal thickness/density

  at 30, 60, 90 days after procedure

• Improvement of transepidermal water loss (TEWL)

  at 30, 60, 90 days after procedure

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Device: monopolar radiofrequency; Other: Standard Cream

Interventions

monopolar radiofrequency DEVICE

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

Control group; Test group

SkinCeuticals A.G.E and Skinceuticals CE FERULIC OTHER

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

Test group

Standard Cream OTHER

Control Side applies Standard Cream

Control group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yes Skin Medical Group: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: January 30, 2024
• Primary Completion: March 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01