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

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT05098912

Collaborator

(none)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Problems Wrinkle	Other: Manual acupuncture Other: Thread embedding acupuncture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 8, 2021

Actual Primary Completion Date :

Jan 26, 2022

Actual Study Completion Date :

Jan 26, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

Principal Investigator: Yolanda Teja, Faculty of Medicine, University of Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yolanda Teja, Resident Doctor of Medical Acupuncture Study Programme University of Indonesia, Indonesia University, Indonesia University

ClinicalTrials.gov Identifier:

NCT05098912

Other Study ID Numbers:

21060651

First Posted:

Oct 28, 2021

Last Update Posted:

Feb 9, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yolanda Teja, Resident Doctor of Medical Acupuncture Study Programme University of Indonesia, Indonesia University, Indonesia University

Acupuncture

Thread embedding acupuncture

Aesthetic

Study Results

No Results Posted as of Feb 9, 2022