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

NCT ID: NCT05748470

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-28
• Study Completion Date: 2023-10-30

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.

Conditions

Skin Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test group

Group Type: EXPERIMENTAL

SkinCeuticals A.G.E

Intervention Type: OTHER

Ultrasound therapy combined with SkinCeuticals A.G.E + conventional moisturizing and sunscreen.

Control group

Group Type: ACTIVE_COMPARATOR

standard cream

Intervention Type: OTHER

Ultrasound therapy combined with standard cream + conventional moisturizing and sunscreen

Interventions

SkinCeuticals A.G.E

Ultrasound therapy combined with SkinCeuticals A.G.E + conventional moisturizing and sunscreen.

Intervention Type: OTHER

standard cream

Ultrasound therapy combined with standard cream + conventional moisturizing and sunscreen

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yes Skin Medical Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hang Zhou YesSkin Hospital

Hangzhou, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Weimin Song

Role: primary

drsong@yesskin.cn

+8613588189292

References

Jiang X, Peng S, Chen Y, Nan Y, Song W. A Randomized, Investigator-Blinded, Split-Face, Controlled Trial Evaluating the Efficacy and Satisfaction of a Topical Product Containing Blueberry Extract and Pro-Xylane Combined With Micro-Focused Ultrasound for Anti-aging. J Cosmet Dermatol. 2025 Jul;24(7):e70281. doi: 10.1111/jocd.70281.

Reference Type: DERIVED

PMID: 40635529 (View on PubMed)

Other Identifiers

WSong

Identifier Type: -

Identifier Source: org_study_id