Comparing Polydioxanone Thread Embedding Acupuncture and Manual Acupuncture for Nasolabial Fold Reduction

Study Overview
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Brief Summary
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This study was aimed to compare the effectiveness of polydioxanone thread embedding acupuncture and manual acupuncture on the reduction of the nasolabial fold. One cycle of therapy in the manual acupuncture group (MA) was carried out with 6 sessions of manual acupuncture therapy while one cycle of therapy in the thread embedding acupuncture group (TEA) received 1 single session of thread embedding acupuncture. The outcome of the study was assessed based on the length of the nasolabial fold as measured by a digital vernier caliper, changes in wrinkle severity rating scale, and patient's subjective opinion of her nasolabial fold using visual analog scale. Outcome measurements were carried out after completing 1 cycle, and follow up at 2 weeks, 1 month, 2 months and 3 months after completing 1 cycle.

Official Title
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The Effectiveness of Polydioxanone Thread Embedding Acupuncture Compared to Manual Acupuncture for Nasolabial Fold Reduction

Conditions
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Aging Problems, Wrinkle

Intervention / Treatment
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* Other: Manual acupuncture
* Other: Thread embedding acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman Age 30-50 years old WSRS scale 3 to 4 Willing to follow the research to completion Subjects who do not have a history of filler injection and/implants, laser therapy, microdermabrasion, peeling, botulinum toxin therapy, manual acupuncture on the face, thread embedding acupuncture on the face and does not either oral or topically use collagen within 6 months Body mass index of ≥ 18.5 Signed the informed consent Exclusion Criteria: Subjects with facial muscle paralysis disorders Subjects with history of keloids and/or hypertrophic scars, subjects with tumors or infection or inflammation at the treatment area Subjects with allergies to stainless steel, PDO threads, topical anesthetics lidocaine Pregnant and lactating subjects Subjects with cancer Subjects with history of bleeding disorders or are taking anticoagulant or antiplatelet. Subjects suffering from fever (≥ 37.5°C), cough, fatigue Subjects with blood glucose POCT (Point of Care Testing) levels of ≥ 200 mg/dl

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual acupuncture<br>The subjects/population of this study is woman at age 30-50 who meet the inclusion criteria. Subjects group with manual acupuncture treatment will be treated with 6 session of manual acupuncture at: From the superior of zygomatic arch through ST 2 to LI 20 bilaterally using a needle size of 0.25 x 60 mm From the inferior of zygomatic arch through SI 18 to ST 4 bilaterally using a needle size of 0.25 x 60 mm From ST 7 to ST 4 bilaterally using a needle size of 0.25 x 60 mm Along the nasolabial crease through ST 4 to the bilateral EXHN-8 using a needle size of 0.25 x 40 mm | Other: Manual acupuncture<br>* Manual acupuncture using filiform needle<br>|
| Active Comparator: Thread embedding acupuncture<br>The subjects/population of this study is woman at age 30-50 who meet the inclusion criteria. Subjects group with thread embedding acupuncture group treatment will be treated with 1 session of thread embedding acupuncture at: From the superior of zygomatic arch through ST 2 to LI 20 bilaterally using a gauge and length of the needle of 31G x 50 mm From the inferior of zygomatic arch through SI 18 to ST 4 bilaterally using a gauge and length of the needle of 31G x 50 mm From ST 7 to ST 4 bilaterally using a gauge and length of the needle of 31G x 50 mm Along the nasolabial crease through ST 4 to the bilateral EXHN-8 using a gauge and length of the needle of 31G x 30 mm | Other: Thread embedding acupuncture<br>* Thread Embedding acupuncture using Polydioxanone thread<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasolabial fold length | Mean difference of nasolabial fold length (measured using digital vernier calipers in millimeters) between two groups | Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up | 
| Wrinkle severity rating scale (WSRS) | Mean difference of WSRS between two groups | Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) | Mean difference of VAS (patient's subjective opinion of her nasolabial fold) between two groups | Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 months, and 3 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Thread embedding acupuncture, Aesthetic