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

Not Applicable

Completed

• Conditions: Wrinkle; Aging Problems
• Interventions: Other: Manual acupuncture; Other: Thread embedding acupuncture

• Registration Number: NCT05098912
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-08
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-28
• Status Verified: 2022-01
• Primary Completion: 2022-01-26
• Study Completion: 2022-01-26
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual acupuncture	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
Thread embedding acupuncture	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia