Nasolabial FoldNCT07877870
Tissue Repositioning Versus Tissue Support in Thread Lifting for Nasolabial Fold Correction: A Randomized, Evaluator-Blinded, Parallel-Group Controlled Trial
A study testing predominantly tissue-repositioning thread lifting and predominantly tissue-support thread-lifting in people with Nasolabial Fold, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This randomized clinical trial compares two minimally invasive thread-lifting procedures for improving moderate-to-severe nasolabial folds, the lines that run from the sides of the nose toward the corners of the mouth. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- predominantly tissue-repositioning thread lifting and predominantly tissue-support thread-lifting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2022to 20 Nov 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy Chinese female or male between 18 and 65 years.
- Bilateral nasolabial fold wrinkles assessed as severity grade ≥ 3 on the Wrinkle Severity Rating Scale (WSRS).
- Willing to accept thread lifting for nasolabial fold correction.
- The subject voluntarily participates in this trial and has signed the informed consent.
Who cannot join
- ·With a hypersensitive constitution.
- With tendency to develop hypertrophic or keloid scars.
- With known history of bleeding disorders.
- With inflammation or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma, …).
- With psychological disorders or psychiatric illnesses.
- Under laser therapy or chemical peeling in the treatment area within 6 months, or injection of botulinum toxin type A within 6 months.
Show all 11Show fewer
- Injection of non-permanent fillers (e.g., hyaluronic acid, collagen) in the treatment area within 1 year.
- Prior facial implantation of permanent fillers.
- Use of anticoagulant or antiplatelet medications within 2 weeks prior to surgery.
- Women who were pregnant, planning pregnancy, or breastfeeding.
- Other conditions deemed unsuitable for participation in the clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized clinical trial compares two minimally invasive thread-lifting procedures for improving moderate-to-severe nasolabial folds, the lines that run from the sides of the nose toward the corners of the mouth. Both procedures use absorbable threads placed under the skin, but they differ in their main treatment approach. One procedure is designed primarily to lift and reposition sagging facial tissues, whereas the other is designed primarily to provide local support and added volume beneath and around the folds.
Approximately 180 adults with moderate-to-severe nasolabial folds will be randomly assigned to one of the two treatment groups. An independent evaluator who does not know the treatment assignment will assess changes in the nasolabial folds during follow-up. The main purpose of the study is to compare the effectiveness of the two procedures 7 months after treatment. The study will also assess early improvement, participants' and evaluators' overall impressions of the results, and treatment-related adverse events and safety.
- Conditions
- Nasolabial Fold
- Being tested
- predominantly tissue-repositioning thread lifting, predominantly tissue-support thread-lifting
- Keywords
- Nasolabial fold; thread lifting; polydioxanone; facial rejuvenation; randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
predominantly tissue-repositioning thread liftingProcedure or surgery
A predominantly tissue-repositioning and multi-plane tissue-lifting thread-lifting protocol for correction of moderate-to-severe nasolabial folds.
predominantly tissue-support thread-liftingProcedure or surgery
A predominantly tissue-support and multiregional volumization thread-lifting protocol for correction of moderate-to-severe nasolabial folds.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants received a predominantly tissue-repositioning and multi-plane tissue-lifting thread-lifting protocol for correction of moderate-to-severe nasolabial folds. Receives: Procedure: predominantly tissue-repositioning thread lifting |
| Active Comparator | Active comparator | A predominantly tissue-support and multiregional volumization thread-lifting protocol for correction of moderate-to-severe nasolabial folds. Receives: Procedure: predominantly tissue-support thread-lifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS effective rate (ER) for NLF correction at 7 months post-operation
The ER was calculated as the percentage of effective responses among subjects in the relevant analysis population.
Measured: 7 months post-operation
Secondary outcomes (3)
ERs of NLF correction
The ERs of NLF correction immediately after surgery (V2) and at 14 days (V3), 1 month (V4), and 3 months (V5) postoperatively.
Measured: Immediately after surgery (V2) and at 14 days (V3), 1 month (V4), and 3 months (V5) postoperatively
Percentage improvement in WSRS scores
Percentage improvement in WSRS scores (%) was calculated as [(baseline WSRS score - post-operation WSRS score) / baseline WSRS score] × 100%
Measured: Immediately after surgery (V2), and at 14 days (V3), 1 month (V4), 3 months (V5), and 7 months (V6) postoperatively.
The mean GAIS scores
The mean GAIS scores at all follow-up visits (V2-V6). The GAIS was a 5-point scale (1 = very much improved; 5 = worse), assessed independently by the subjects and independent evaluators.
Measured: Immediately after surgery (V2), and at 14 days (V3), 1 month (V4), 3 months (V5), and 7 months (V6) postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start21 Jun 2022
- Primary completion3 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leiyue Li, Ph.D., Study director, Math, Computer Science, and Statistics Department, St. Lawrence University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877870
- Sponsor's protocol ID
- BeijingTCGH_plastic
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Repositioning Versus Tissue Support in Thread Lifting for Nasolabial Fold Correction: A Randomized, Evaluator-Blinded, Parallel-Group Controlled Trial
- ClinicalTrials.gov ID
- NCT07877870
- Acronym / sponsor ID
- BeijingTCGH_plastic
- Conditions
- Nasolabial Fold
- Keywords
- Nasolabial fold; thread lifting; polydioxanone; facial rejuvenation; randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 16 Oct 2026 (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 randomized clinical trial compares two minimally invasive thread-lifting procedures for improving moderate-to-severe nasolabial folds, the lines that run from the sides of the nose toward the corners of the mouth. Both procedures use absorbable threads placed under the skin, but they differ in their main treatment approach. One procedure is designed primarily to lift and reposition sagging facial tissues, whereas the other is designed primarily to provide local support and added volume beneath and around the folds.
Approximately 180 adults with moderate-to-severe nasolabial folds will be randomly assigned to one of the two treatment groups. An independent evaluator who does not know the treatment assignment will assess changes in the nasolabial folds during follow-up. The main purpose of the study is to compare the effectiveness of the two procedures 7 months after treatment. The study will also assess early improvement, participants' and evaluators' overall impressions of the results, and treatment-related adverse events and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: predominantly tissue-repositioning thread liftingParticipants received a predominantly tissue-repositioning and multi-plane tissue-lifting thread-lifting protocol for correction of moderate-to-severe nasolabial folds. |
| Active Comparator | Active comparator | Procedure: predominantly tissue-support thread-liftingA predominantly tissue-support and multiregional volumization thread-lifting protocol for correction of moderate-to-severe nasolabial folds. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy Chinese female or male between 18 and 65 years.
Key exclusion criteria (11 listed)
- ·With a hypersensitive constitution.
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 |
|---|---|---|
| predominantly tissue-repositioning thread liftingA predominantly tissue-repositioning and multi-plane tissue-lifting thread-lifting protocol for correction of moderate-to-severe nasolabial folds. | Procedure or surgery | Experimental |
| predominantly tissue-support thread-liftingA predominantly tissue-support and multiregional volumization thread-lifting protocol for correction of moderate-to-severe nasolabial folds. | Procedure or surgery | Active Comparator |
Primary outcome
WSRS effective rate (ER) for NLF correction at 7 months post-operation
Time frame: 7 months post-operation
The ER was calculated as the percentage of effective responses among subjects in the relevant analysis population.
3 secondary outcomes
ERs of NLF correction
Time frame: Immediately after surgery (V2) and at 14 days (V3), 1 month (V4), and 3 months (V5) postoperatively
Percentage improvement in WSRS scores
Time frame: Immediately after surgery (V2), and at 14 days (V3), 1 month (V4), 3 months (V5), and 7 months (V6) postoperatively.
The mean GAIS scores
Time frame: Immediately after surgery (V2), and at 14 days (V3), 1 month (V4), 3 months (V5), and 7 months (V6) postoperatively.
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 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Nasolabial Fold
Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds
Active, not recruiting
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Nasolabial Fold
Not yet recruiting
Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study
Nasolabial Folds
RecruitingPhase 3
Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults
Nasolabial Folds
Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit
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.
Leiyue Li, Ph.D. study director
Math, Computer Science, and Statistics Department, St. Lawrence University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing predominantly tissue-repositioning thread lifting and predominantly tissue-support thread-lifting in people with Nasolabial Fold, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
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 4 inclusion and 11 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 16 Oct 2026. 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 China. 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?
WSRS effective rate (ER) for NLF correction at 7 months post-operation (time frame: 7 months post-operation). 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 16 Oct 2026.