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CompletedNCT02432742Updated Aug 26, 2022Results posted

Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds

An interventional study of Restylane Perlane and Restylane in Nasolabial Folds in Chinese Population, sponsored by Galderma R&D. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.

02

Conditions studied

  • Nasolabial Folds in Chinese Population

Keywords

  • hyaluronic acid, comparative study, NLF
03

In context

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chinese origin
  • Subjects intent to undergo correction of both NLFs with a Wrinkle Severity Rating Scale (WSRS) of 3 on both side or 4 on both side.
  • Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
  • Singed Informed Consent

Exclusion criteria

Exclusion Criteria:

  • Subjects with traumatic scars or ongoing active skin disease in the area to be treated
  • Permanent inplant or filler, including fat injection placed in the area to be treated
  • Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion
  • Any medical condition in the opinion of the treating investigator who will make the subject unsuitable for inclusion
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Restylane Perlane

    Single injection and optional touch up injection with Restylane Perlane in NLF

    Device: Restylane Perlane

  • Active comparator
    Restylane

    Single injection and optional touch up injection with Restylane in NLF

    Device: Restylane

Interventions

  • DeviceRestylane Perlane

    Intradermal injection

  • DeviceRestylane

    Intradermal injection

06

What researchers measure

Primary outcomes

  1. Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months

    The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade).

    Time frame: 6 months

07

Results

Posted Dec 23, 2020

Participant flow

Participant flow — Overall Study
MilestoneRestylane Perlane in One NLF and Restylane in the Other NLF
Started100
Completed95
Not completed5

Outcome measures

PrimaryMean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months

The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade).

Time frame:
6 months
Reported as:
Mean · units on a scale
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months
units on a scaleRestylane Perlane NLFsRestylane NLFs
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months-0.03 ± 0.030.03 ± 0.03

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Restylane Perlane in One NLF and Restylane in the Other NLF0/100 (0%)2/100 (2%)16/100 (16%)
Most frequent serious events
Most frequent serious events
EventRestylane Perlane in One NLF and Restylane in the Other NLF
Multi organ failure, infectionInfections and infestations1/100
Bladder lesion excisionSurgical and medical procedures1/100
Most frequent other events
Most frequent other events
EventRestylane Perlane in One NLF and Restylane in the Other NLF
NasopharyngitisInfections and infestations9/100
Upper respiratory tract infectionInfections and infestations5/100
Implant site bruisingGeneral disorders1/100
Implant site bruisingGeneral disorders1/100

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Restylane Perlane in One NLF and Restylane in the Other NLF
<=18 years0
Between 18 and 65 years100
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Restylane Perlane in One NLF and Restylane in the Other NLF
Sex — Female98
Sex — Male2
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Restylane Perlane in One NLF and Restylane in the Other NLF
Ethnicity — Han Chinese97
Ethnicity — Other (Manchu, Tujia, Hui)3
Region of Enrollment
Region of Enrollment(Participants)Restylane Perlane in One NLF and Restylane in the Other NLF
China100
WSRS score of either 3 on both sides or 4 on both sides as assessed by an Independent Evaluator
WSRS score of either 3 on both sides or 4 on both sides as assessed by an Independent Evaluator(Participants)Restylane Perlane in One NLF and Restylane in the Other NLF
Count of participants100
08

Study locations

3 sites
  • Beijing, China
  • Wuhan, China
  • Zhejiang, China
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02432742
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
May 4, 2015
Start date
May 2015
Primary completion
Mar 2016
Completion
Aug 2016
Results posted
Dec 23, 2020
Last update
Aug 26, 2022

Study contacts

Q-Med AB
study director · Galderma R&D

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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