Clinical trial NCT05098912: Comparing Polydioxanone Thread Embedding Acupuncture and Manual Acupuncture for Nasolabial Fold Reduction
Official title: The Effectiveness of Polydioxanone Thread Embedding Acupuncture Compared to Manual Acupuncture for Nasolabial Fold Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Problems
Wrinkle
Keywords: Acupuncture
Thread embedding acupuncture
Aesthetic
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Nasolabial fold length
timeFrame: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up
measure: Wrinkle severity rating scale (WSRS)
timeFrame: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 months, and 3 months follow up
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Yolanda Teja
role: PRINCIPAL_INVESTIGATOR
References: