NCT07664280

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jun 2026Aug 2027

First Submitted

Initial submission to the registry

June 11, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 11, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 11, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

Facial Rejuvenation AcupunctureAcupuncture TherapyDermal ThicknessSkin RejuvenationHigh-Frequency Ultrasound3D Facial ScanningFacial ContouringPatient Satisfaction

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

EXPERIMENTAL

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)

Waitlist Control Group

NO INTERVENTION

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.

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.

Also known as: Single-Session Facial Acupuncture, Cosmetic Acupuncture, Facial Rejuvenation Acupuncture, FRA
Single FRA

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Neihu Lixin TCM Clinic

Taipei, 114, Taiwan

RECRUITING

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.

  • 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.

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Jen-Tang Sun, physician

CONTACT

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
Model Details: This is a single-blind, randomized, waitlist-controlled trial. Participants are randomized into two parallel groups. The intervention group receives a single session of facial rejuvenation acupuncture at Week 0. The waitlist control group receives no intervention (maintains routine skincare) for the first 6 weeks, and then receives a compensatory single session of facial acupuncture at Week 6.
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.

Locations