N/A
N=100
Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds
Nasolabial Folds in Chinese Population
Bottom Line
View on ClinicalTrials.gov: NCT02432742 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Dec 2020
Primary outcome: Primary: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months — -0.03; 0.03 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Perlane (Device); Restylane (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months |
-0.03; 0.03 | — |
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.
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT02432742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.