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The use of high-frequency microneedle technology and microfocused ultrasound alone or in combination for facial rejuvenation treatment: a prospective, randomized, half-face, comparative clinical trial

The use of high-frequency microneedle technology and microfocused ultrasound alone or in combination for facial rejuvenation treatment: a prospective, randomized, half-face, comparative clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087490
Enrollment
Unknown
Registered
2024-07-29
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Tightening

Interventions

Group A:Half face treated with focused ultrasound (Peninsula Medical Co., Ltd., Shenzhen, China)
Group B:Half face treated with microneedle rediofrequency (Peninsula Medical Co., Ltd., Shenzhen, China)
Group C:Half face treated with focused ultrasound combined with microneedle rediofrequency (Peninsula Medical Co., Ltd., Shenzhen, China)

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 25-65 years (inclusive of 25 and 65 years) who meet the indications for facial skin aging. 2. Patients with facial sagging who have never received any other treatment, with the baseline sagging graded using the Alexiades Comprehensive Grading Scale (ACGS), and have scores of 1.5 or above for both wrinkles (manifested as two or more static wrinkles) and sagging (manifested as slight folds in the nasolabial fold and lower eyelid laxity). 3. Patients or their legal guardians who have fully understood the treatment plan and risks, willingly sign the informed consent form, agree to participate in a self-controlled trial, and cooperate with follow-up. 4. Patients with no obvious asymmetry between the left and right faces, regardless of gender.

Exclusion criteria

Exclusion criteria: 1. Pregnant women or women planning to become pregnant. 2. Patients allergic to surface disinfectants. 3. Patients with facial wounds or epidermal ulcerations. 4. Patients with severe organic diseases or mental illnesses. 5. Patients currently participating in other clinical trials. 6. Participants who have received laser or energy-based treatments, cosmetic surgeries (such as fillers, injections, plastic surgeries), and/or chemical peels in the past year. 7. Participants with a history of impaired healing or scarring disorders.

Design outcomes

Primary

MeasureTime frame
Visual analog scale, VAS;

Secondary

MeasureTime frame
Volume change;Skin and fat thickness;

Countries

China

Contacts

Public ContactXiaoxi Lin

Shanghai 9th People's Hospital, Shanghai Jiaotong University, School of Medicine

kernelldz@sina.com+86 188 1786 5253

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026