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NCT Number: NCT07664280

Effect of Single Facial Acupuncture on Dermal Structure and Appearance Satisfaction

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Facial Rejuvenation Acupuncture (FRA)

Procedure

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

Primary outcomes

  1. Change in Dermal Thickness

    Time frame: Baseline (Week 0) to Week 6

    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.

Secondary outcomes

  1. Change in Facial Volume and Contour

    Time frame: Baseline (Week 0) to Week 6

    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).

  2. Change in Skin Density

    Time frame: Baseline (Week 0) to Week 6

    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 (%)

  3. Change in Wrinkle Depth

    Time frame: Baseline (Week 0) to Week 6

    Quantified measurement of wrinkle depth using a digital complexion analysis system (VISIA). Reported in millimeters (mm).

  4. Change in Wrinkle Quantity

    Time frame: Baseline (Week 0) to Week 6

    Quantified measurement of the absolute number of wrinkles using a digital complexion analysis system (VISIA). Reported as a count.

  5. Change in Patient-Reported Appearance Satisfaction

    Time frame: Assessed using the FACE-Q Satisfaction with Appearance Scale. Higher scores indicate a better outcome (greater satisfaction with appearance).

    Assessed using standardized questionnaires to evaluate the patient's subjective changes in appearance satisfaction, self-confidence, and quality of life/social function scores.

  6. Change in Skin Surface Smoothness

    Time frame: Baseline (Week 0) to Week 6

    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.

  7. Change in Quality of Life

    Time frame: Baseline (Week 0) to Week 6

    Description: Assessed using the Dermatology Life Quality Index. Higher scores indicate a worse outcome (greater negative impact on quality of life).

Study contacts

Contact information is provided by the study sponsor or research team.

Jen-Tang Sun, physician

CONTACT

[email protected]

+88677281843

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Collaborators

  • Neihu Lixin TCM Clinic

Registry information

Official study title

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

Acronym: FRA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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