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Completed

NCT Number: NCT05098912

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

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.

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Key information

Conditions

Aging Problems Wrinkle

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual acupuncture

Other

Manual acupuncture using filiform needle

Thread embedding acupuncture

Other

Thread Embedding acupuncture using Polydioxanone thread

Primary outcomes

  1. Nasolabial fold length

    Time frame: 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

  2. Wrinkle severity rating scale (WSRS)

    Time frame: 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 outcomes

  1. Visual analog scale (VAS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2021
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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