The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Galderma Research Site
Kaohsiung City, Taiwan
Galderma Research Site
Taipei, Taiwan
Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant
Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.
Time frame: 6 Months
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator
The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds". A participant is considered improved if she scores at least one grade improvement from baseline.
Time frame: 6 and 12 Months after first and second treatment, respectively
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator
The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek". A participant is assessed as improved if she scores at least one grade improvement from baseline.
Time frame: 6 and 12 Months after first and second treatment, respectively
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