Aging ProblemsNCT05098912
Comparing Polydioxanone Thread Embedding Acupuncture and Manual Acupuncture for Nasolabial Fold Reduction
A study testing Manual acupuncture and Thread embedding acupuncture in people with Aging Problems and Wrinkle, run by Universitas Indonesia at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging Problems, Wrinkle
- What is being tested?
- Manual acupuncture and Thread embedding acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Sep 2021to 26 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Effectiveness of Polydioxanone Thread Embedding Acupuncture Compared to 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.
- Conditions
- Aging Problems, Wrinkle
- Being tested
- Manual acupuncture, Thread embedding acupuncture
- Keywords
- Acupuncture, Thread embedding acupuncture, Aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual acupunctureOther
Manual acupuncture using filiform needle
Thread embedding acupunctureOther
Thread Embedding acupuncture using Polydioxanone thread
| Study group | Role | What they receive |
|---|---|---|
| Manual acupuncture | Active comparator | The subjects/population of this study is woman at age 30-50 who meet the inclusion criteria. Subjects group with manual acupuncture treatment will be treated with 6 session of manual acupuncture at:
From the superior of zygomatic arch through ST 2 to LI 20 bilaterally using a needle size of 0.25 x 60 mm From the inferior of zygomatic arch through SI 18 to ST 4 bilaterally using a needle size of 0.25 x 60 mm From ST 7 to ST 4 bilaterally using a needle size of 0.25 x 60 mm Along the nasolabial crease through ST 4 to the bilateral EXHN-8 using a needle size of 0.25 x 40 mm Receives: Other: Manual acupuncture |
| Thread embedding acupuncture | Active comparator | The subjects/population of this study is woman at age 30-50 who meet the inclusion criteria. Subjects group with thread embedding acupuncture group treatment will be treated with 1 session of thread embedding acupuncture at:
From the superior of zygomatic arch through ST 2 to LI 20 bilaterally using a gauge and length of the needle of 31G x 50 mm From the inferior of zygomatic arch through SI 18 to ST 4 bilaterally using a gauge and length of the needle of 31G x 50 mm From ST 7 to ST 4 bilaterally using a gauge and length of the needle of 31G x 50 mm Along the nasolabial crease through ST 4 to the bilateral EXHN-8 using a gauge and length of the needle of 31G x 30 mm Receives: Other: Thread embedding acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasolabial fold length
Mean difference of nasolabial fold length (measured using digital vernier calipers in millimeters) between two groups
Measured: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up
Wrinkle severity rating scale (WSRS)
Mean difference of WSRS between two groups
Measured: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up
Secondary outcomes (1)
Visual analog scale (VAS)
Mean difference of VAS (patient's subjective opinion of her nasolabial fold) between two groups
Measured: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 months, and 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start8 Sep 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yolanda Teja, Universitas Indonesia
- Investigators
- Yolanda Teja, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098912
- Sponsor's protocol ID
- 21060651
- Status last verified
- Jan 2022
- First submitted
- 20 Oct 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Polydioxanone Thread Embedding Acupuncture Compared to Manual Acupuncture for Nasolabial Fold Reduction
- ClinicalTrials.gov ID
- NCT05098912
- Acronym / sponsor ID
- 21060651
- Conditions
- Aging Problems, Wrinkle
- Keywords
- Acupuncture, Thread embedding acupuncture, Aesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual acupuncture | Active comparator | Other: Manual acupunctureThe subjects/population of this study is woman at age 30-50 who meet the inclusion criteria. Subjects group with manual acupuncture treatment will be treated with 6 session of manual acupuncture at: From the superior of zygomatic arch through ST 2 to LI 20 bilaterally using a needle size of 0.25 x 60 mm From the inferior of zygomatic arch through SI 18 to ST 4 bilaterally using a needle size of 0.25 x 60 mm From ST 7 to ST 4 bilaterally using a needle size of 0.25 x 60 mm Along the nasolabial crease through ST 4 to the bilateral EXHN-8 using a needle size of 0.25 x 40 mm |
| Thread embedding acupuncture | Active comparator | Other: Thread embedding acupunctureThe subjects/population of this study is woman at age 30-50 who meet the inclusion criteria. Subjects group with thread embedding acupuncture group treatment will be treated with 1 session of thread embedding acupuncture at: From the superior of zygomatic arch through ST 2 to LI 20 bilaterally using a gauge and length of the needle of 31G x 50 mm From the inferior of zygomatic arch through SI 18 to ST 4 bilaterally using a gauge and length of the needle of 31G x 50 mm From ST 7 to ST 4 bilaterally using a gauge and length of the needle of 31G x 50 mm Along the nasolabial crease through ST 4 to the bilateral EXHN-8 using a gauge and length of the needle of 31G x 30 mm |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual acupunctureManual acupuncture using filiform needle | Other | Manual acupuncture |
| Thread embedding acupunctureThread Embedding acupuncture using Polydioxanone thread | Other | Thread embedding acupuncture |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda Teja principal investigator
Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual acupuncture and Thread embedding acupuncture in people with Aging Problems and Wrinkle, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasolabial fold length (time frame: Before intervention (baseline), after completing 1 cycle, at 2 weeks, 1 month, 2 month, and 3 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.