A Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Aging
• Intervention / Treatment: Other: SkinCeuticals A.G.E; Other: standard cream

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Hang Zhou YesSkin Hospital
    • Contact: Weimin Song; Phone Number: +8613588189292; Email: drsong@yesskin.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Chinese subjects aged 18-65 years inclusive;
2. The subject 's facial skin is rough, flaccid, and lack of elasticity;
3. 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;
4. Subjects who have consistent facial skin status on both sides and plan to receive ultrasound therapy;
5. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
6. Subjects understand the nature of the study and sign the informed consent form (ICF).

Exclusion Criteria:

1. 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);
2. Subjects with facial skin diseases, infection, inflammation or allergic constitution that may affect the judgment of the test results;
3. Subjects with hypertrophic scar or scar constitution;
4. 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;
5. Patients who have oral or topical cosmetic products that may affect the test results within the past 2 weeks;
6. 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;
7. Female subjects who are pregnant, lactating or plan to become pregnant;
8. Other subjects who are not suitable for participating in this study as assessed by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: standard cream; Ultrasound therapy combined with standard cream + conventional moisturizing and sunscreen
Experimental: Test group	Other: SkinCeuticals A.G.E; Ultrasound therapy combined with SkinCeuticals A.G.E + conventional moisturizing and sunscreen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global aesthetic improvement scale （GAIS） score	Investigator Satisfaction Assessment Form. Scoring criteria: 5 (very much improved), 4 (marked improvement), 3 (improved), 2 (no change), or 1 (worse).	at day 90 after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline 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, 180 days after procedure
Relative change from baseline in skin elasticity		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 in transepidermal water loss(TEWL) from baseline		at 30, 60, 90, 180 days after procedure
Investigator satisfaction assessment	Investigator Satisfaction Assessment Form. Questions included: 1. Integrated skincare effect of ultrasonic program. 2, Feeling overall improvement of facial wrinkles after using the product. 3, Feeling that the elasticity of facial skin is improved after using the product. 4, Feeling that facial skin fullness improved after using the product. 5. Feeling that the skin moisture is improved after using the product. Satisfaction ratings were divided into: 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, 180 days after surgery
Subject satisfaction evaluation	Subject Satisfaction Assessment Form. Questions included: 1. Integrated skincare effect of ultrasonic program. 2, Feeling overall improvement of facial wrinkles after using the product. 3, Feeling that the elasticity of facial skin is improved after using the product. 4, Feeling that facial skin fullness improved after using the product. 5. Feeling that the skin moisture is improved after using the product. Satisfaction ratings were divided into: 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, 180 days after procedure
Global aesthetic improvement scale （GAIS） score	Investigator Satisfaction Assessment Form. Scoring criteria: 5 (very much improved), 4 (marked improvement), 3 (improved), 2 (no change), or 1 (worse).	at day 30,60,180 after procedure

Collaborators and Investigators

• Sponsor: Yes Skin Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 19, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: WSong

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No