Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects

Study Overview
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Brief Summary
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Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.

Official Title
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A Prospective Clinical Study to Evaluate Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects

Conditions
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Lip Augmentation

Intervention / Treatment
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* Device: Restylane Kysse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects willing to comply with the requirements of the study and providing a signed written informed consent Ability to adequately understand the verbal explanations and the written subject information provided in English Subjects seeking augmentation therapy for the lips Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent Exclusion Criteria: Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim. Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit. Previous facial surgery, within 6 months, below the level of the lower orbital rim Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma. Participation in any interventional clinical study within 30 days of screening

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Restylane Kysse<br>Hyaluronic Acid | Device: Restylane Kysse<br>* Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants assessed as at least 1-point improvement from baseline on MLFS | Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full' | Week 8 | 
| Proportion of participants assessed as at least 1-point improvement from baseline on MLFS | Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full' | Week 16 | 
| Proportion of participants assessed as at least 1-point improvement from baseline on MLFS | Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full' | Week 24 | 
| Proportion of participants assessed as at least 1-point improvement from baseline on MLFS | Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full' | Week 32 | 
| Proportion of participants assessed as at least 1-point improvement from baseline on MLFS | Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full' | Week 40 | 
| Proportion of participants assessed as at least 1-point improvement from baseline on MLFS | Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full' | Week 48 | 
| Change from baseline/last injection on MLFS | Lip fullness after treatment in the upper and lower lips is evaluated by the Investigator. Lip fullness is quantified with the 5-graded Medicis Lip Fullness Scale (MLFS) with options grade 1 or 'Very Thin', (2) 'Thin', (3) 'Medium', (4) 'Full', and (5) 'Very Full'. Change from baseline after last injection will be calculated for the upper and lower lip separately and presented using descriptive statistics. | Weeks 8, 16, 24, 32, 40 and 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants assessed as at least 1-point improvement from baseline on WAS | Aesthetic improvement of the upper perioral rhytids and oral commissures is evaluated by the Investigator. Aesthetic improvement is evaluated with the 6-graded Wrinkle Assessment Scale (WAS) with options grade 0 or 'No wrinkles', (1) 'Just perceptible wrinkle', (2) 'Shallow wrinkles', (3) 'Moderately deep wrinkle', (4) 'Deep wrinkle, well-defined edges', (5) 'Very deep wrinkle, redundant fold' | Weeks 8, 16, 24, 32, 40, and 48 | 
| Percentage of participants assessed as at least improved on the GAIS | Aesthetic improvement after treatment in chin and nasolabial fold/marionette line, respectively, and in combination is evaluated by Treating Investigator. Aesthetic improvement is evaluated with the 5-graded Global Aesthetic Improvement Scale (GAIS) with options 'worse', 'no change', 'improved', 'much improved', 'very much improved'. | Weeks 8, 16, 24, 32, 40, and 48 |