New Dermal Filler for Lip Augmentation

Study Overview
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Brief Summary
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To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation

Official Title
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A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study to Evaluate the Effectiveness and Safety of Restylane Kysse Versus a Control in the Augmentation of Soft Tissue Fullness of the Lip

Conditions
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Lip Augmentation

Intervention / Treatment
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* Device: New Dermal Filler
* Device: Device: FDA Approved Dermal Filler


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. Males or non-pregnant, non-breastfeeding females, 22 years of age or older. Seeking augmentation therapy for the lips Exclusion Criteria: Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins. Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Dermal Filler<br>hyaluronic acid | Device: New Dermal Filler<br>* hyaluronic acid<br>|
| Active Comparator: Dermal Filler<br>hyaluronic acid | Device: Device: FDA Approved Dermal Filler<br>* hyaluronic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) | The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at 8 weeks after last injection of New Dermal Filler or Dermal Filler (control). | 8 weeks after last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at X weeks after last injection of New Dermal Filler. | 16, 24, 32, 40, and 48 weeks after last injection | 
| Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Based on Response Rates (defined as at least 1 point improvement from baseline) after treatment with New Dermal Filler | 16, 24, 32, 40, and 48 weeks | 
| Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Based on Change from Baseline, New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. | 8, 16, 24, 32, 40, and 48 weeks after last injection | 
| Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Based on Response Rates (defined as at least 1 point improvement from baseline), New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. . | 8, 16, 24, 32, 40, and 48 weeks | 
| Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Responders defined as at least improved (improved, much improved, very much improved) as assessed by subject, upper and lower lip combined, New Dermal Filler | 8, 16, 24, 32, 40, and 48 weeks | 
| Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler | 8, 16, 24, 32, 40, and 48 weeks | 
| Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler | 8, 24, 40, and 48 weeks | 
| Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Subjects' satisfaction using the validated FACE-Q scales Satisfaction with Lips and Appraisal of Lines: Lips at baseline and at Week 8, 16, 24, 32, 40, and 48 weeks after last injection based on individual questions in each questionnaire as well as the Rasch transformed total scores and the change from baseline in the Rasch transformed scores. Rasch-transformed total score (0-100) according the FACE-Q manual; the higher total score indicated greater subject satisfaction.A positive change from baseline indicates an improvement. Baseline is defined as the last observation before initial treatment takes place at the baseline visit on Day 1. | 8, 16, 24, 32, 40, and 48 weeks |