Efficacy and Safety Evaluation of Microfocused Ultrasound Combined With 1550 nm Non-Ablative Fractional Laser for Facial Rejuvenation

NCT07107308 | Active Not Recruiting DMC

• 1 other identifier: 2025008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study adopted the research method of a single-center case-control study. According to the inclusion and exclusion criteria, 25 patients with facial photoaging were included. After the treatment, various skin indicators of the patients were evaluated and followed up. Both the researchers and the subjects were in an open state. The researchers measured and evaluated various indicators of the patients' skin. Patients diagnosed with facial photoaging underwent VISIA photography, digital camera photography, non-invasive skin testing, dermoscopy testing and high-frequency skin ultrasound testing after enrollment. On the day of enrollment, micro-focused ultrasound (using treatment heads S1.5, S2, N3, N4.5, P1.5, P2.0, P3.0, and P4.5) was performed on both sides of the face once. One side of the face was randomly selected as the experimental side, and a 1550 nm non-ablative fractional laser treatment was performed immediately after the micro-focused ultrasound treatment once. For the second treatment, micro-focused ultrasound (using S1.5, S2, P1.5, and P2.0 treatment heads) was performed on both sides once. The experimental side was treated with 1550 nm non-ablative fractional laser once immediately after the micro-focused ultrasound treatment. The research period was May, including a treatment period of 2 months. Follow-up was conducted every two weeks for a total of 10 times, all of which were on-site visits. The grace period during the visit is ±3 days.

Conditions

Photo-aged Skin

Outcome Measures

Primary Outcomes (1)

• GAIS(Global Aesthetic Improvement Scale) Score

  Minimum 0 points, maximum 4 points. The higher the score, the better the therapeutic effect.

  week 0、4、8、12、16

Secondary Outcomes (1)

• Dermal Thickness

  week 0、4、8、12、16

Other Outcomes (4)

• Melanin Index

  week 0、4、8、12、16

• Erythema Index(EI)

  week 0、4、8、12、16

• Skin Hydration

  week 0、4、8、12、16

Study Arms (2)

Microfocused Ultrasound Device (MFUpro, Zhengzhou, China)

EXPERIMENTAL

Device: Microfocused Ultrasound

Erbium-Doped Fiber Laser Therapeutic Device(FraxStar ShenGuang 1550, Beijing, China)

EXPERIMENTAL

Device: Erbium-Doped Fiber Laser

Interventions

Microfocused Ultrasound DEVICE

Before treatment, clean the treatment area, mark the treatment zone, and evenly apply a layer of ultrasound coupling agent about the thickness of a coin on the treatment area. The patient's face was treated with S1.5, S2, N3, N4.5, P1.5, P2.0, P3.0 and P4.5 treatment heads respectively. After the treatment, the face was cleaned and a medical mask was applied for 15 minutes. After the treatment, attention was paid to moisturizing and sun protection.

Microfocused Ultrasound Device (MFUpro, Zhengzhou, China)

Erbium-Doped Fiber Laser DEVICE

Doctors and patients wear corresponding protective glasses. Apply cold gel to the treatment area on the patient's face and select certain treatment parameters based on the patient's skin lesion condition and skin type. After the treatment, clean your face. Decide whether to apply ice based on the severity of the skin lesion reaction. If ice application is necessary, the regular ice application time is 15 to 30 minutes, and apply a medical mask for 15 minutes. After the treatment, pay attention to moisturizing and sun protection.

Erbium-Doped Fiber Laser Therapeutic Device(FraxStar ShenGuang 1550, Beijing, China)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with facial skin photoaging diagnosed by clinicians \[Photoaging Score (GPS)1-4 points\];
• Male or female patients aged 30 to 60 years old;
• Patients with Fitzpatrick9 skin wrinkle grades I to III;
• Patients who voluntarily participate and sign the informed consent form.

You may not qualify if:

• The degree of photoaging on both sides of the face varies relatively significantly;
• There are mobile or metal implants on the face;
• Severe or cystic acne on the face;
• There was a history of facial injection or surgery within 6 months before the trial;
• Severe keloid constitution;
• There is a history of allergy to local anesthetics, iodophor or photosensitivity.
• Have a history of bleeding tendency;
• Suffering from serious skin diseases such as skin tumors;
• Suffering from autoimmune diseases, systemic diseases or mental disorders;
• Women who are planning to become pregnant, are pregnant or breastfeeding;
• There is a frequent need for makeup;
• There is a long-term need for outdoor work and sun protection is not possible.
• Patients with poor compliance, which affects clinical efficacy and the judgment of adverse reactions.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: August 6, 2025
• Study Start: November 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)