Effect of Single Facial Acupuncture on Dermal Structure and Appearance Satisfaction (FRA)

Effects of Single-Session Facial Acupuncture on Dermal Structure and Aesthetic Satisfaction: A Randomized Controlled Trial Combining High-Frequency Ultrasound and Patient-Reported Outcomes

This study aims to investigate the effects of a single session of facial rejuvenation acupuncture on skin structure and personal satisfaction with facial appearance. As facial aging involves complex changes in muscles, skin, and soft tissues, facial acupuncture is considered a potential minimally invasive treatment to help restore balance and promote tissue repair.

Researchers will enroll 60 healthy adults aged 30 to 60 who are concerned about facial aging. Participants will be randomly assigned to either an immediate intervention group or a waitlist control group. The intervention group will receive one session of facial acupuncture at the start of the study. The control group will continue their normal daily skincare routine for 6 weeks, after which they will receive the same single acupuncture treatment.

All participants will be monitored weekly for 6 weeks. The research team will use non-invasive tools, including high-frequency skin ultrasound, 3D facial scanning, and a digital complexion analysis system, to objectively measure changes in skin thickness, facial volume, and wrinkles. Participants will also complete questionnaires at various time points to share their satisfaction with their appearance, self-confidence, and quality of life.

Study Overview

• Status: Recruiting
• Conditions: Skin Aging; Wrinkles; Facial Aging
• Intervention / Treatment: Procedure: Facial Rejuvenation Acupuncture (FRA)

Detailed Description

Facial aging is a complex, multi-layered process involving cranial bone resorption, fat pad redistribution, and biomechanical imbalances within the superficial musculo-aponeurotic system (SMAS) and facial expression muscles. While conventional aesthetic treatments like botulinum toxin, dermal fillers, and surgical facelifts are effective, they are associated with potential limitations such as expression stiffness, vascular risks, high costs, and extended recovery times. Consequently, Facial Rejuvenation Acupuncture (FRA) has emerged as a minimally invasive alternative designed to promote endogenous tissue repair with minimal downtime.

The potential physiological mechanisms of FRA include: regulating myofascial tension by targeting specific expression muscles to restore biomechanical balance; initiating a wound-healing cascade via micro-trauma to stimulate collagen synthesis; and enhancing local microcirculation through axon reflexes. Despite its growing clinical popularity, most existing research focuses on the cumulative effects of 5 to 10 sessions, leaving a significant gap in understanding the temporal dynamics of a single intervention. It remains unclear whether a single FRA session produces only a short-term "Cinderella effect" or initiates a sustained tissue remodeling process. Furthermore, previous studies have heavily relied on subjective assessments rather than objective quantification.

To address these gaps, this single-blind, randomized, waitlist-controlled trial aims to systematically evaluate the short-to-mid-term biological effects of a single FRA session over a 6-week period. Sixty eligible adults (aged 30-60) will be randomly allocated via sealed envelopes to an intervention group or a waitlist control group. The intervention group receives a single comprehensive FRA treatment at Week 0, targeting 20 specific anatomical structures across the neck, jaw, perioral, cheek, periorbital, and fascial regions to release ligament adhesions and adjust muscle tension. The control group maintains routine non-invasive skincare for 6 weeks before receiving a compensatory FRA treatment. To establish robust evidence, objective multi-modal imaging and assessments will be conducted weekly for all participants.

These tools include:

1.High-Frequency Skin Ultrasound (DUB Cutis): To measure changes in dermal thickness and assess collagen density via echogenicity.

2.3D Facial Scanning (Morpheus 3D): To quantify mid-to-lower face soft tissue volume changes and evaluate lifting effects via curved length measurements. 3.Digital Skin Analysis (VISIA): To objectively assess wrinkle depth, quantity, and overall skin surface texture.

In parallel with objective imaging, Patient-Reported Outcome Measures (PROMs) will track subjective changes in appearance satisfaction, self-confidence, and quality of life. Data collected across the 7 time points (Baseline to Week 6) will be analyzed using Linear Mixed Models (LMM) to evaluate the dynamic trends and interactions of the treatment effects over time.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jen-Tang Sun, physician; Phone Number: +88677281843; Email: tangtang05231980@hotmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Recruiting
    • Neihu Lixin TCM Clinic
    • Contact: Jui-Pin Shen, physician; Phone Number: +886-2-2633-1255; Email: bingosjp@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 30 to 60 years old. Individuals concerned about facial aging issues.
• Individuals without severe chronic diseases.

Exclusion Criteria:

• Pregnant women.
• Individuals with coagulation disorders.
• Individuals with a keloid constitution or tendency for abnormal scarring.
• Individuals with acute or chronic facial hemiplegia/paralysis of any cause.
• Individuals who have undergone facial cosmetic surgery or cosmetic injections within the past 6 months.
• Individuals currently taking anticoagulant medications.
• Individuals with active skin infections.
• Individuals with a history of severe allergies.
• Individuals otherwise deemed unsuitable for facial acupuncture by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single FRA; Participants randomized to this arm will receive a single, comprehensive Facial Rejuvenation Acupuncture (FRA) session at Week 0. The treatment targets 20 key anatomical structures, including facial and neck muscles, as well as specific ligaments, to balance myofascial tension and stimulate tissue repair. Following the single intervention, participants will use only routine non-invasive skincare (moisturizer/lotion) and undergo weekly assessments using ultrasound, 3D scanning, and digital complexion analysis for 6 weeks.	Procedure: Facial Rejuvenation Acupuncture (FRA); This intervention consists of a single, comprehensive session of Facial Rejuvenation Acupuncture (FRA). The procedure targets 20 specific anatomical structures across the neck, jaw, perioral, cheek, periorbital, and upper face regions. The acupuncturist uses specific needling techniques (e.g., flat, oblique, and deep insertions) to balance myofascial tension-relaxing hypertonic muscles (such as the corrugator and masseter) and stimulating hypotonic muscles (such as the zygomaticus major/minor). Additionally, ligament release techniques are applied to vertical and horizontal retaining ligaments to stimulate tissue remodeling. The intervention is administered once at Week 0 for the experimental arm, and once at Week 6 for the waitlist control arm.; Other Names: Single-Session Facial Acupuncture; Cosmetic Acupuncture; Facial Rejuvenation Acupuncture; FRA
No Intervention: Waitlist Control Group; Participants randomized to this arm will not receive any active treatment during the primary 6-week study period. They are instructed to maintain their routine non-invasive daily skincare (using only basic moisturizer or lotion). During these 6 weeks, they will undergo the same weekly assessments as the experimental group. After the Week 6 assessments are completed, participants in this waitlist group will receive a compensatory single session of the same Facial Rejuvenation Acupuncture (FRA) provided to the experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dermal Thickness	Measured as the change in thickness (in µm) from the sub-epidermis to the upper margin of the subcutaneous fat layer using high-frequency skin ultrasound (DUB Cutis). This objective metric reflects the microstructural changes and extracellular matrix remodeling stimulated by the intervention.	Baseline (Week 0) to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Facial Volume and Contour	Measured as the difference in mid-to-lower face soft tissue volume (in cc) and changes in lifting curved length (e.g., from tragus to the corner of the mouth) using 3D facial scanning (Morpheus 3D Scanner).	Baseline (Week 0) to Week 6
Change in Skin Density	Assessed by analyzing the change in dermal echogenicity using a high-frequency skin ultrasound (DUB Cutis). Echogenicity is measured quantitatively as the pixel density, reported in percentage (%)	Baseline (Week 0) to Week 6
Change in Wrinkle Depth	Quantified measurement of wrinkle depth using a digital complexion analysis system (VISIA). Reported in millimeters (mm).	Baseline (Week 0) to Week 6
Change in Wrinkle Quantity	Quantified measurement of the absolute number of wrinkles using a digital complexion analysis system (VISIA). Reported as a count.	Baseline (Week 0) to Week 6
Change in Patient-Reported Appearance Satisfaction	Assessed using standardized questionnaires to evaluate the patient's subjective changes in appearance satisfaction, self-confidence, and quality of life/social function scores.	Assessed using the FACE-Q Satisfaction with Appearance Scale. Higher scores indicate a better outcome (greater satisfaction with appearance).
Change in Skin Surface Smoothness	Quantified measurement of overall skin surface smoothness using a digital complexion analysis system (VISIA). Reported in Absolute Score where a higher value indicates smoother skin.	Baseline (Week 0) to Week 6
Change in Quality of Life	Description: Assessed using the Dermatology Life Quality Index. Higher scores indicate a worse outcome (greater negative impact on quality of life).	Baseline (Week 0) to Week 6

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Collaborators: Neihu Lixin TCM Clinic

Publications and helpful links

General Publications

• Haghir H, Yazdanpanah MJ, Khadem-Rezaiyan M, Bidouei F, Azizi H. Effects of Face and Body Acupuncture on Glabellar Frown Lines in Women Aged 30-59: a Study Protocol for a Double-Arm Randomized Waitlist-Controlled Trial. J Acupunct Meridian Stud. 2024 Dec 31;17(6):221-228. doi: 10.51507/j.jams.2024.17.6.221.
• Haghir H, Yazdanpanah MJ, Farahmand SK, Khadem-Rezaiyan M, Azizi H. Is Acupuncture Effective in Diminishing Frown Lines? Evidence From a Randomized Controlled Trial. J Cosmet Dermatol. 2025 Apr;24(4):e70144. doi: 10.1111/jocd.70144.
• Rerksuppaphol L, Charoenpong T, Rerksuppaphol S. Randomized clinical trial of facial acupuncture with or without body acupuncture for treatment of melasma. Complement Ther Clin Pract. 2016 Feb;22:1-7. doi: 10.1016/j.ctcp.2015.10.004. Epub 2015 Oct 30.
• Yun Y, Choi I. Effect of thread embedding acupuncture for facial wrinkles and laxity: a single-arm, prospective, open-label study. Integr Med Res. 2017 Dec;6(4):418-426. doi: 10.1016/j.imr.2017.09.002. Epub 2017 Sep 19.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Patient Satisfaction; Acupuncture Therapy; Facial Contouring; Skin Rejuvenation; High-Frequency Ultrasound; Facial Rejuvenation Acupuncture; Dermal Thickness; 3D Facial Scanning
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction
• Other Study ID Numbers: 115070-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share Individual Participant Data (IPD) with other researchers. According to the approved Institutional Review Board (IRB) protocol and informed consent form, all participant data will be strictly de-identified and managed under the principle of minimum necessary use. The data will be securely stored on encrypted drives accessible only to authorized research team members. To protect participant privacy and strictly comply with data protection regulations, individual-level data will not be made publicly available, nor will it be shared for secondary research purposes outside the scope of this specific trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No