Clinical trial NCT05748470: A Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Aging
Lead sponsor: Yes Skin Medical Group
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Global aesthetic improvement scale （GAIS） score
timeFrame: at day 90 after procedure
Secondary outcomes:
measure: Change from baseline in fine lines score
timeFrame: at 30, 60, 90, 180 days after procedure
measure: Relative change from baseline in skin elasticity
timeFrame: at 30, 60, 90, 180 days after procedure
measure: Relative change from baseline in dermal thickness
timeFrame: at 30, 60, 90, 180 days after procedure
measure: Relative change in transepidermal water loss(TEWL) from baseline
timeFrame: at 30, 60, 90, 180 days after procedure
measure: Investigator satisfaction assessment
timeFrame: at 30, 60, 90, 180 days after surgery
measure: Subject satisfaction evaluation
timeFrame: at 30, 60, 90, 180 days after procedure
measure: Global aesthetic improvement scale （GAIS） score
timeFrame: at day 30,60,180 after procedure
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hang Zhou YesSkin Hospital
Study officials:
References: