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

NCT05748470 | Unknown

• 1 other identifier: WSong
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in fine lines score

  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

  at 30, 60, 90, 180 days after surgery

Study Arms (2)

Test group

EXPERIMENTAL

Other: SkinCeuticals A.G.E

Control group

ACTIVE COMPARATOR

Other: standard cream

Interventions

SkinCeuticals A.G.E OTHER

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

Test group

standard cream OTHER

Ultrasound therapy combined with standard cream + conventional moisturizing and sunscreen

Control group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yes Skin Medical Group: lead

Study Sites (1)

Hang Zhou YesSkin Hospital

Hangzhou, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40635529 DERIVED

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: February 3, 2023
• First Posted: February 28, 2023
• Study Start: March 28, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CN (1)