- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06952959
The Effects of Cosmetic Acupuncture
April 29, 2025 updated by: Chia-Hui Lin, China Medical University Hospital
Using Professional Intelligent Skin Analyzers to Analyze the Effects of Cosmetic Acupuncture on Skin Health and Aging: A Randomized Controlled Trial
The study recruited 40 subjects and divided them into an intervention group and a waiting list group in a 1:1 ratio using a randomized controlled trial.
The changes in skin health and aging-related indicators before and after TCM cosmetic acupuncture treatment were analyzed.
The subjects are of all genders and aged between 30 and 60 years old.
The TCM cosmetic acupuncture treatment is arranged twice a week for a three-week course.
The study will conduct a skin test before and after the TCM cosmetic acupuncture, and use the Antera 3D smart skin detector to comprehensively evaluate the subjects' skin condition.
Antera 3D Skin Detector can detect multiple skin indicators, including wrinkle depth, skin tone uniformity and subtle changes in the skin surface, melanin, red pigment, etc.
After the treatment, the subjects' acceptance and satisfaction with TCM cosmetic acupuncture were collected.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chia-Hui Lin
- Phone Number: 886+910127501
- Email: ffyeva@gmail.com
Study Locations
-
-
-
Taichung, Taiwan, 40447
- Recruiting
- China Medical University Hospital
-
Contact:
- Chia-Hui Lin
- Email: ffyeva@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- both female and male
- 30 to 60 years old
- never had acupuncture beauty treatment, or the last time they had acupuncture beauty treatment has been more than six months.
Exclusion Criteria:
- medical cosmetic fillers on their face
- cosmetic surgery
- needle sickness
- afraid of acupuncture
- wounds on the facial skin
- poor wound healing
- abnormal coagulation function
- severe diabetes
- keloids
- dialysis
- cancer patients undergoing chemotherapy or radiotherapy
- pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cosmetic acupuncture group
accept treatment session
|
Cosmetic acupuncture
|
|
Other: Waitinglist for cosmetic acupuncture group
wait for 3 weeks then accept the same treatment session
|
Cosmetic acupuncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Face Skin Texture
Time Frame: Intervention group: the 1st, 4th week; waiting list group: the 1st, 4th, and 7th week.
|
Professional Intelligent Skin Analyzers accurately locate the comparison before and after cosmetic acupuncture sessions, showing high accuracy and reproducibility, analyzing Ra value (unit: µm) as arithmetic mean roughness of the skin's contours.
|
Intervention group: the 1st, 4th week; waiting list group: the 1st, 4th, and 7th week.
|
|
Face Skin Color
Time Frame: Intervention group: the 1st, 4th week; waiting list group: the 1st, 4th, and 7th week.
|
Professional Intelligent Skin Analyzers accurately locate the comparison before and after cosmetic acupuncture sessions, showing high accuracy and reproducibility, analyzing L*a*b value (no unit) as the skin's color.
(L*: Lightness, a*: Red/Green Value, b*: Blue/Yellow Value)
|
Intervention group: the 1st, 4th week; waiting list group: the 1st, 4th, and 7th week.
|
|
Face Pore Size
Time Frame: Intervention group: the 1st, 4th week; waiting list group: the 1st, 4th, and 7th week.
|
Professional Intelligent Skin Analyzers accurately locate the comparison before and after cosmetic acupuncture sessions, showing high accuracy and reproducibility, analyzing average pore volume (unit: mm²).
|
Intervention group: the 1st, 4th week; waiting list group: the 1st, 4th, and 7th week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Questionnaire of satisfaction and acceptance of cosmetic acupuncture
Time Frame: Intervention group: the 4th week; waiting list group: the 7th week.
|
The questionnaire include three domains: 1. Visual Analogue Scale score measures pain intensity.
The VAS consists of 10 points, with two end points representing 0 ("no pain") and 10 ("pain as bad as it could possibly be").
2. The acceptance of cosmetic acupuncture has 0~4 points, 0 representing "unacceptable" and 4 representing "totally acceptable".
3. Facial Check Sheet(FCS) has 12 items about the satisfaction of the improvement of face appearance including wrinkles, laxity, facial shape, and pigmented spots, and so on.
0 representing "very dissatisfied" and 4 representing "very satisfied".
Subjects can also choose "no need to pay attention" if they don't have the concerned problems of appearance.
|
Intervention group: the 4th week; waiting list group: the 7th week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2025
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
April 10, 2025
First Submitted That Met QC Criteria
April 29, 2025
First Posted (Actual)
May 1, 2025
Study Record Updates
Last Update Posted (Actual)
May 1, 2025
Last Update Submitted That Met QC Criteria
April 29, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- CMUH114-REC2-018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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