The Effects of Cosmetic Acupuncture
Using Professional Intelligent Skin Analyzers to Analyze the Effects of Cosmetic Acupuncture on Skin Health and Aging: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- CMUH114-REC2-018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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