Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Subjects intent to undergo facial filler treatment for either volume loss or contouring
Subjects requiring treatment in two to four of pre-defined areas in the face (upper cheeks, nasolabial folds, temples, nose and chin)
Require 3-5 ml of investigational products to achieve a clinically meaningful improvement in appearance
Facial appearance as Han Chinese
Non-pregnant, non-breast feeding female
Signed informed consent

Exclusion Criteria

Previous facial surgery (e.g. rhinoplasty) or permanent implant in the area to be treated.
History of chronic sinusitis or rhinitis (only applicable for subjects injected in the nose).
Subjects who needs to use heavy glasses during the study (only applicable for subjects injected in the nose).
Previous tissue augmenting therapy or contouring with permanent filler or fat injection in the facial area.
Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skinboosters in the facial area within 12 months before treatment.
Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment.
Previous revitalization with neurotoxin in the facial area within six (6) months before treatment.
Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment.
Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).

Arm && Interventions

Group	Intervention	Description
Intradermal injection	Perlane	Restylane and/or Perlane
Intradermal injection	Restylane	Restylane and/or Perlane

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant	6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator	6 and 12 Months after first and second treatment, respectively	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.
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator	6 and 12 Months after first and second treatment, respectively	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.