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
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2026
CompletedStudy Start
First participant enrolled
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
June 24, 2026
June 1, 2026
1.2 years
June 11, 2026
June 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Change in Facial Volume and Contour
Baseline (Week 0) to Week 6
Change in Skin Density
Baseline (Week 0) to Week 6
Change in Wrinkle Depth
Baseline (Week 0) to Week 6
Change in Wrinkle Quantity
Baseline (Week 0) to Week 6
Change in Patient-Reported Appearance Satisfaction
Assessed using the FACE-Q Satisfaction with Appearance Scale. Higher scores indicate a better outcome (greater satisfaction with appearance).
- +2 more secondary outcomes
Study Arms (2)
Single FRA
EXPERIMENTALParticipants 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.
Waitlist Control Group
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults aged 30 to 60 years old. Individuals concerned about facial aging issues.
- Individuals without severe chronic diseases.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Far Eastern Memorial Hospitallead
- Neihu Lixin TCM Cliniccollaborator
Study Sites (1)
Neihu Lixin TCM Clinic
Taipei, 114, Taiwan
Related Publications (4)
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.
PMID: 39722645RESULTHaghir 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.
PMID: 40193060RESULTRerksuppaphol 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.
PMID: 26850796RESULTYun 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.
PMID: 29296569RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the physical nature of acupuncture, participants and the care provider (acupuncturist) cannot be blinded. Single-blinding is applied to the outcomes assessor who operates the imaging devices (ultrasound, 3D scanner, VISIA) and performs the data analysis.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physician
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 24, 2026
Study Start
June 11, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
June 24, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
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.