A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging in Real World Clinical Practice

Yes Skin Medical Group1 site in 1 country50 target enrollmentMarch 28, 2023

ConditionsSkin Aging

Overview

Phase: N/A
Intervention: Not specified
Conditions: Skin Aging
Sponsor: Yes Skin Medical Group
Enrollment: 50
Locations: 1
Primary Endpoint: Global aesthetic improvement scale （GAIS） score
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 satisfaction of ultrasound therapy combined with SkinCeuticals A.G.E in improving facial aging, and to explore the medical value of ultrasound therapy combined with SkinCeuticals A.G.E. Participants will be treated with ultrasound combined with SkinCeuticals A.G.E on one randomized side face and ultrasound combined with standard cream on the other side.

Registry

clinicaltrials.gov

Start Date

March 28, 2023

End Date

October 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yes Skin Medical Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Chinese subjects aged 18-65 years inclusive;
•The subject 's facial skin is rough, flaccid, and lack of elasticity;
•Subjects with multiple facial fine lines (perioral/periocular/forehead, etc.), decree lines or puppet lines area with static fine lines trend, the lower part showed signs of loosening;
•Subjects who have consistent facial skin status on both sides and plan to receive ultrasound therapy;
•Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
•Subjects understand the nature of the study and sign the informed consent form (ICF).

Exclusion Criteria

•Subjects with contraindications to ultrasound treatment (such as malignant tumor, acute systemic infection, severe heart disease, bleeding tendency, etc.) or contraindications to A.G.E use (or allergic to other skin care components);
•Subjects with facial skin diseases, infection, inflammation or allergic constitution that may affect the judgment of the test results;
•Subjects with hypertrophic scar or scar constitution;
•Receiving treatment of tightening medical treatment program (Thermage/Fotona 4D/ultrasound/microneedle, etc.) or planning to receive other tightening medical treatment program and drugs during this treatment in the past 3 months;
•Patients who have oral or topical cosmetic products that may affect the test results within the past 2 weeks;
•Subjects who have participated in drug clinical trials or other trials within the past 30 days (or are participating in), or have used drugs affecting the test results within 1 week;
•Female subjects who are pregnant, lactating or plan to become pregnant;
•Other subjects who are not suitable for participating in this study as assessed by the investigator.

Outcomes

Primary Outcomes

Global aesthetic improvement scale （GAIS） score

Time Frame: at day 90 after procedure

Investigator Satisfaction Assessment Form. Scoring criteria: 5 (very much improved), 4 (marked improvement), 3 (improved), 2 (no change), or 1 (worse).

Secondary Outcomes

Relative change in transepidermal water loss(TEWL) from baseline(at 30, 60, 90, 180 days after procedure)
Relative change from baseline in dermal thickness(at 30, 60, 90, 180 days after procedure)
Relative change from baseline in skin elasticity(at 30, 60, 90, 180 days after procedure)
Investigator satisfaction assessment(at 30, 60, 90, 180 days after surgery)
Global aesthetic improvement scale （GAIS） score(at day 30,60,180 after procedure)
Subject satisfaction evaluation(at 30, 60, 90, 180 days after procedure)
Change from baseline in fine lines score(at 30, 60, 90, 180 days after procedure)