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

Study Overview
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Brief Summary
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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.

Official Title
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An Open, Evaluator-blinded, Non-comparative, Multi-center Study to Assess the Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Restylane
* Device: Perlane


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradermal injection<br>Restylane and/or Perlane | Device: Restylane<br>* Facial tissue augmentation<br>Device: Perlane<br>* Facial tissue augmentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 and 12 Months after first and second treatment, respectively |