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

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

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.

Study Overview

• Status: Completed
• Conditions: Wrinkle; Aging Problems
• Intervention / Treatment: Other: Manual acupuncture; Other: Thread embedding acupuncture

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual acupuncture; 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; Manual acupuncture using filiform needle
Active Comparator: Thread embedding acupuncture; 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; Thread Embedding acupuncture using Polydioxanone thread

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Yolanda Teja, Faculty of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; Thread embedding acupuncture; Aesthetic
• Other Study ID Numbers: 21060651

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