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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098912
• Other study ID #: 21060651
• Status: Completed
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: January 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging Problems
• Wrinkle

Intervention

Other:
• Manual acupuncture
Manual acupuncture using filiform needle
• Thread embedding acupuncture
Thread Embedding acupuncture using Polydioxanone thread

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Visual analog scale (VAS)	Mean difference of VAS (patient's subjective opinion of her nasolabial fold) between two groups	Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 months, and 3 months follow up