NCT02432742CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Outcomes
Primary Outcomes
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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