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

2026年6月17日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Taipei、台湾、114
        • 募集
        • Neihu Lixin TCM Clinic
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
他の名前:
  • Single-Session Facial Acupuncture
  • Cosmetic Acupuncture
  • Facial Rejuvenation Acupuncture
  • FRA
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Dermal Thickness
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Facial Volume and Contour
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月11日

一次修了 (推定)

2027年8月31日

研究の完了 (推定)

2027年8月31日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月17日

最初の投稿 (実際)

2026年6月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月24日

QC基準を満たした最後の更新が送信されました

2026年6月17日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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