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

NCT05098912 | Completed

• 1 other identifier: 21060651
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging Problems; Wrinkle

Keywords

Acupuncture; Thread embedding acupuncture; Aesthetic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Visual analog scale (VAS)

  Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 months, and 3 months follow up

Study Arms (2)

Manual acupuncture

ACTIVE COMPARATOR

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

Thread embedding acupuncture

ACTIVE COMPARATOR

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

Interventions

Manual acupuncture OTHER

Manual acupuncture using filiform needle

Manual acupuncture

Thread embedding acupuncture OTHER

Thread Embedding acupuncture using Polydioxanone thread

Thread embedding acupuncture

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• Yolanda Teja

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor of Medical Acupuncture Study Programme University of Indonesia, Indonesia University

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 28, 2021
• Study Start: September 8, 2021
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)