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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05098912
Enrollment
30
Registered
2021-10-28
Start date
2021-09-08
Completion date
2022-01-26
Last updated
2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging Problems, Wrinkle

Keywords

Acupuncture, Thread embedding acupuncture, Aesthetic

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.

Interventions

Manual acupuncture using filiform needle

Thread Embedding acupuncture using Polydioxanone thread

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Nasolabial fold lengthBefore intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow upMean 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 upMean difference of WSRS between two groups

Secondary

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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026