UMIN-ICDS Clinical Trial

Public title

Comparing Two Minimally Invasive Thread-Lifting Treatments for Moderate-to-Severe Nasolabial Folds

Acronym

TRS-NLF

Scientific Title

Tissue Repositioning versus Tissue Support in Thread Lifting for Nasolabial Fold Correction: A Multicenter, Randomized, Evaluator-Blinded, Parallel-Group Controlled Trial

Scientific Title:Acronym

TRS-NLF

Region

Asia(except Japan)

Condition

Moderate-to-severe nasolabial folds

Classification by specialty

Plastic surgery

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the efficacy and safety of two minimally invasive thread-lifting protocols for correction of moderate-to-severe nasolabial folds.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

WSRS effective rate of nasolabial fold correction at 7 months postoperatively, defined as improvement of at least one WSRS grade from baseline based on the poorer side.

Key secondary outcomes

WSRS effective rates at earlier follow-up visits; percentage improvement in WSRS scores; investigator- and participant-rated GAIS scores; and safety outcomes.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Experimental intervention: predominantly multi-plane tissue-repositioning and lifting thread-lifting protocol, including malar fat pad lifting, temporal lifting, zygomatic lifting, and local nasolabial fold support with absorbable threads.

Interventions/Control_2

Active comparator: predominantly multiregional tissue-support and volumization thread-lifting protocol, including nasolabial fold support, infraorbital and paranasal support, and infraorbital/paranasal lifting with absorbable threads.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Healthy Chinese men or women aged 18 to 65 years.
2. Bilateral nasolabial fold wrinkles with a severity grade >= 3 on the Wrinkle Severity Rating Scale (WSRS).
3. Willing to undergo thread lifting for correction of nasolabial folds.
4. Willing to participate in the study and able to provide written informed consent.

Key exclusion criteria

1.With a hypersensitive constitution.
2.With tendency to develop hypertrophic or keloid scars.
3.With known history of bleeding disorders.
4.With inflammation or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma).
5.With psychological disorders or psychiatric illnesses.
6.Under laser therapy or chemical peeling in the treatment area within 6 months, or injection of botulinum toxin type A within 6 months.
7.Injection of non-permanent fillers (e.g., hyaluronic acid, collagen) in the treatment area within 1 year.
8.Prior facial implantation of permanent fillers.
9.Use of anticoagulant or antiplatelet medications within 2 weeks prior to surgery.
10.Women who were pregnant, planning pregnancy, or breastfeeding.
11.Other conditions deemed unsuitable for participation in the clinical trial by the investigator.

Target sample size

180

Name of lead principal investigator

1st name	Jianmin
Middle name
Last name	Yang

Organization

Beijing Tsinghua Changgung Hospital

Division name

Department of Plastic Surgery

Zip code

102218

Address

168 Litang Road, Changping District, Beijing, China

TEL

19842469579

Email

dryangjianmin@163.com

Name of contact person

1st name	Jianmin
Middle name
Last name	Yang

Organization

Beijing Tsinghua Changgung Hospital

Division name

Department of Plastic Surgery

Zip code

102218

Address

168 Litang Road, Changping District, Beijing, China

TEL

19842469579

Homepage URL

Email

dryangjianmin@163.com

Institute

Beijing Tsinghua Changgung Hospital

Institute

Department

Personal name

Organization

Beijing Tsinghua Changgung Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Beijing Tsinghua Changgung Hospital

Address

168 Litang Road, Changping District, Beijing, China

Tel

56118567

Email

IRB@btch.edu.cn

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

04

Day

URL releasing protocol

https://zenodo.org/records/23136551

Publication of results

Unpublished

URL related to results and publications

https://zenodo.org/records/23136551

Number of participants that the trial has enrolled

182

Results

At 7 months, ER was 80.5% in the tissue-repositioning group and 53.8% in the tissue-support group (difference, 26.70 percentage points; P < 0.0001). The tissue-repositioning protocol was non-inferior and had a higher ER. Secondary efficacy outcomes were consistent. AEs were more frequent with tissue repositioning (94.3% vs. 84.9%; P = 0.04), including pain (89.7% vs. 71.0%; P = 0.002) and surface irregularity (59.8% vs. 31.2%; P = 0.0001). No serious AEs occurred.

Results date posted

2026

Year

10

Month

04

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The mean age was 45.45 years in the experimental group and 44.24 years in the control group (P = 0.33). The proportion of female subjects was 96.6% in the experimental group and 94.6% in the control group. There were no statistically significant differences between the two groups regarding age, sex, height, weight, BMI, or baseline WSRS score (P > 0.05).

Participant flow

Of 205 individuals assessed, 23 failed screening and 182 were randomized to the experimental group (n = 89) or control group (n = 93). Two randomized subjects in the experimental group withdrew before receiving the assigned procedure and were therefore excluded from the FAS and SS. Ultimately, the experimental group included 87 subjects in both the FAS and the SS. The control group included 93 subjects in both sets. The PPS comprised 83 subjects in the experimental group and 88 in the control group.

Adverse events

Safety analyses included 87 subjects in the experimental group and 93 subjects in the control group. At least one AE was reported by 82 subjects (94.3%) in the experimental group and 79 subjects (84.9%) in the control group. Mild AEs were the most frequently reported severity category, occurring in 81 subjects (93.1%) and 78 subjects (83.9%), respectively. Moderate AEs occurred in 11 subjects (12.6%) and 11 subjects (11.8%), whereas severe AEs occurred in 1 subject (1.1%) and 2 subjects (2.2%), respectively. No serious AEs occurred. The most common AEs were local reactions at the surgical site, such as pain, swelling/ecchymosis/erythema, and skin irregularity, the majority of which were mild and resolved spontaneously. Any AE (94.3% vs. 84.9%; P = 0.04), pain (89.7% vs. 71.0%; P = 0.002), and skin irregularity (59.8% vs. 31.2%; P = 0.0001) were significantly higher in the experimental group than in the control group. No statistically significant between-group difference was observed in the incidence of swelling/ecchymosis/erythema (P > 0.05). Paresthesia occurred in 2 subjects (2.3%) in the experimental group and 1 subject (1.1%) in the control group (P = 0.61). No hematoma, infection, or thread exposure was reported in either group. AE categories, including severity categories, were not mutually exclusive; therefore, subjects could be counted in more than one category.

Outcome measures

Primary Efficacy Outcome

In the FAS, the ER was 80.5% in the experimental group and 53.8% in the control group, yielding a between-group difference of 26.70%. Because the lower bound of the two-sided 95% CI exceeded the prespecified non-inferiority margin of -10% and the corresponding one-sided P value was less than 0.025, non-inferiority was established. A separate two-sided comparison showed a higher 7-month ER in the tissue-repositioning group than in the tissue-support group (P = 0.0001). Because superiority was not prespecified as a confirmatory objective, this finding should be interpreted as exploratory evidence favoring the tissue-repositioning protocol. The PPS analysis yielded comparable results.

Secondary Efficacy Outcome

No statistically significant between-group difference in ER was observed immediately postoperatively (V2). At all subsequent follow-up visits, the FAS showed higher ERs in the experimental group than in the control group. The between-group differences in ERs at V3-V6 were 17.5%, 15.8%, 16.9%, and 26.7%, respectively, and all differences were statistically significant (P < 0.05). The results of the PPS analysis were consistent with those of the FAS analysis.

Both groups showed significant improvement in WSRS scores at all postoperative follow-up visits. The percentage improvement in WSRS scores was significantly greater in the experimental group than in the control group immediately postoperatively [60.0% (IQR, 33.3%-66.6%) vs. 50.0% (IQR, 33.3%-66.6%), P < 0.05]. At 14 days postoperatively, the percentage improvement was 33.3% in both groups and remained unchanged through 3 months. At 7 months postoperatively, the experimental group maintained a 33.3% (IQR, 25.0%-33.3%) improvement in WSRS scores, whereas the percentage improvement in the control group decreased to 25.0% (IQR, 0.0%-33.3%); the difference between the two groups at this time point was statistically significant (P < 0.05). The FAS and PPS analyses yielded consistent results.

Subject-rated mean GAIS scores indicated significantly greater improvement in the experimental group than in the control group at V3-V6 (P < 0.05). In the experimental group, the mean GAIS scores were 2.17, 2.28, 2.37, and 2.63 at 14 days, 1 month, 3 months, and 7 months postoperatively, respectively. The corresponding scores in the control group were 2.64, 2.80, 3.09, and 3.17, respectively. The FAS and PPS analyses yielded consistent results.

Investigator-rated mean GAIS scores in the experimental group at V3-V6 were 1.81, 2.02, 2.38, and 2.65, respectively. The corresponding scores in the control group were 2.54, 2.72, 2.93, and 3.24, respectively. Both the FAS and PPS analyses indicated greater improvement in the experimental group than in the control group at all follow-up time points (P < 0.05).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2023

Year

08

Month

01

Day

Date of IRB

2023

Year

10

Month

19

Day

Anticipated trial start date

2023

Year

11

Month

01

Day

Last follow-up date

2024

Year

06

Month

30

Day

Date of closure to data entry

2024

Year

09

Month

01

Day

Date trial data considered complete

2024

Year

09

Month

30

Day

Date analysis concluded

2024

Year

10

Month

31

Day

Other related information

Registered date

2026

Year

10

Month

04

Day

Last modified on

2026

Year

10

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072296