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

NCT ID: NCT05098912

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2022-01-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Manual acupuncture

Intervention Type: OTHER

Manual acupuncture using filiform needle

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

Group Type: ACTIVE_COMPARATOR

Thread embedding acupuncture

Intervention Type: OTHER

Thread Embedding acupuncture using Polydioxanone thread

Interventions

Manual acupuncture

Manual acupuncture using filiform needle

Intervention Type: OTHER

Thread embedding acupuncture

Thread Embedding acupuncture using Polydioxanone thread

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Yolanda Teja

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yolanda Teja

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Indonesia

Locations

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

21060651

Identifier Type: -

Identifier Source: org_study_id