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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05098912
Other study ID # 21060651
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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