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

2026년 6월 17일 업데이트: Jen-Tang Sun, Far Eastern Memorial Hospital

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Taipei, 대만, 114
        • 모병
        • Neihu Lixin TCM Clinic
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
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.
다른 이름들:
  • Single-Session Facial Acupuncture
  • Cosmetic Acupuncture
  • Facial Rejuvenation Acupuncture
  • FRA
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Dermal Thickness
기간: 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.
Baseline (Week 0) to Week 6

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Facial Volume and Contour
기간: 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).
Baseline (Week 0) to Week 6
Change in Skin Density
기간: 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 (%)
Baseline (Week 0) to Week 6
Change in Wrinkle Depth
기간: Baseline (Week 0) to Week 6
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
기간: 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.
Baseline (Week 0) to Week 6
Change in Patient-Reported Appearance Satisfaction
기간: 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.
Assessed using the FACE-Q Satisfaction with Appearance Scale. Higher scores indicate a better outcome (greater satisfaction with appearance).
Change in Skin Surface Smoothness
기간: 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.
Baseline (Week 0) to Week 6
Change in Quality of Life
기간: 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).
Baseline (Week 0) to Week 6

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 11일

기본 완료 (추정된)

2027년 8월 31일

연구 완료 (추정된)

2027년 8월 31일

연구 등록 날짜

최초 제출

2026년 6월 11일

QC 기준을 충족하는 최초 제출

2026년 6월 17일

처음 게시됨 (실제)

2026년 6월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 17일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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