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A randomized controlled clinical trial: combination of high-intensity focused ultrasound and microneedle radiofrequency in the treatment of facial laxity

A randomized controlled clinical trial: combination of high-intensity focused ultrasound and microneedle radiofrequency in the treatment of facial laxity

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088045
Enrollment
Unknown
Registered
2024-08-09
Start date
2024-08-09
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

facial laxity

Interventions

high-intensity focused ultrasound group :The volunteers received a total of 2 sessions of high-intensity focused ultrasound treatment on both sides of their faces, with an interval of 10 weeks betwe
microneedle radiofrequency:The volunteers received a total of 2 sessions ofmicroneedle radiofrequency treatment on both sides of their faces, with an interval of 10 weeks between each session.
combination group :The subjects first underwent a session of high-intensity focused ultrasound on both sides of their faces. After 10 weeks, they received a session of microneedle radiofrequency trea

Sponsors

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

Eligibility

Sex/Gender
All
Age
30 Years to 55 Years

Inclusion criteria

Inclusion criteria: Patients with facial relaxation, with FLR facial relaxation score ranging from 3 to 8, regardless of gender; aged 30 to 55 years old (including 30 and 55 years old); no other facial treatments received within the past year; after being fully informed of the treatment plan and risks, the patient or guardian voluntarily signs the informed consent form, willing to undergo a self-controlled trial, and cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: Pregnant women or women with fertility plans; allergy to ultrasound coupling agent or topical anesthetics; patients with facial wounds or epidermal ulceration; patients with other skin diseases on the face, such as acne, seborrheic dermatitis, eczema, psoriasis, etc.; patients with severe organic diseases or mental illnesses; patients participating in other clinical trials; patients who have received phototherapy, injection, surgery, or other treatments in the treatment area within the past year; patients undergoing estrogen replacement therapy during menopause; other patients who the researcher believes are not suitable for participation in the trial (such as skin immune diseases, distrust of researchers, etc.).

Design outcomes

Primary

MeasureTime frame
FLR Facial Laxity;

Secondary

MeasureTime frame
Global Aesthetic Improvement Score, GAIS;The Fitzpatrick Wrinkle Classification System,FWCS;

Countries

China

Contacts

Public ContactYali Yang

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

1965559353@qq.com+86 158 0189 1767

Outcome results

None listed

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