Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds
A Randomised, Multi-center, Evaluator-blinded Study in China to Evaluate the Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds
1 other identifier
interventional
100
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
December 23, 2020
CompletedAugust 26, 2022
February 1, 2021
10 months
April 23, 2015
November 26, 2020
August 24, 2022
Conditions
Keywords
Outcome Measures
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).
6 months
Study Arms (2)
Restylane Perlane
EXPERIMENTALSingle injection and optional touch up injection with Restylane Perlane in NLF
Restylane
ACTIVE COMPARATORSingle injection and optional touch up injection with Restylane in NLF
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (3)
Unknown Facility
Beijing, China
Unknown Facility
Wuhan, China
Unknown Facility
Zhejiang, China
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Q-Med AB
Study Officials
- STUDY DIRECTOR
Q-Med AB
Galderma R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2015
First Posted
May 4, 2015
Study Start
May 1, 2015
Primary Completion
March 1, 2016
Study Completion
August 1, 2016
Last Updated
August 26, 2022
Results First Posted
December 23, 2020
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share