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

Skin Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748470
• Other study ID #: WSong
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2023
• Source: Yes Skin Medical Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Aging

Intervention

Other:
• SkinCeuticals A.G.E
Ultrasound therapy combined with SkinCeuticals A.G.E + conventional moisturizing and sunscreen.
• standard cream
Ultrasound therapy combined with standard cream + conventional moisturizing and sunscreen

Locations

Country	Name	City	State
China	Hang Zhou YesSkin Hospital	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Yes Skin Medical Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Relative change from baseline in skin elasticity		at 30, 60, 90, 180 days after procedure
Secondary	Relative change from baseline in dermal thickness		at 30, 60, 90, 180 days after procedure
Secondary	Relative change in transepidermal water loss(TEWL) from baseline		at 30, 60, 90, 180 days after procedure
Secondary	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
Secondary	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
Secondary	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