N/A
Completed N=100
Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds
Nasolabial Folds in Chinese Population
Source: ClinicalTrials.gov NCT02432742 ↗
Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Dec 2020
Primary outcomePrimary: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months — -0.03; 0.03 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months |
-0.03; 0.03 | — |
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. Informational only — not medical advice.