JUVEDERM® Ultra XC vs. Belotero Balance® for Perioral Lines

Study Overview
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Brief Summary
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A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines

Official Title
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A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of JUVEDERM® Ultra XC Injectable Gel Versus Belotero Balance® for Perioral Lines

Conditions
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Patients With Moderate to Severe Perioral Lines

Intervention / Treatment
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* Device: JUVEDERM® Ultra XC
* Device: Belotero Balance®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have moderate to severe perioral lines as assessed by the Investigator using the 4-point POLSS (none, mild, moderate, and severe) Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not study related Exclusion Criteria: Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the perioral area, as judged by the Treating Investigator Have a history of skin cancer Is an active smoker Has noticeable acne scarring, active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth area Have had an active oral herpes or cold sore within 12 months Have undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study Have undergone cosmetic facial or perioral area procedures [e.g., face-lift, or other surgeries which may alter the appearance of the perioral area, including tissue grafting, or tissue augmentation with silicone, fat, or other permanent fillers] or be planning to undergo any of these procedures at any time during the study Have undergone temporary or semi-permanent facial dermal filler injections (e.g., hyaluronic acid, calcium hydroxylapatite, L-Polylactic acid) in the lower face (below the orbital rim) within 24 months Have received mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study other than study related procedures. Have begun use of any new over-the-counter or prescription, oral or topical, antiwrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study. [NOTE: Use of sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrollment] Have had epilation (e.g. laser hair removal, electrolysis, threading, etc.) in the perioral area performed within 3 months Have received treatment with botulinum toxin of any serotype for any indication in the lower face [below the infraorbital rims (IORs)] within 1 year of the baseline visit

Ages Eligible for Study
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Minimum Age: 35 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JUVEDERM® Ultra XC<br>Perioral lines treated with JUVEDERM® Ultra XC | Device: JUVEDERM® Ultra XC<br>* Up to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).<br>|
| Experimental: Belotero Balance®<br>Perioral Lines treated with Belotero Balance® | Device: Belotero Balance®<br>* Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS) | The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported. | Baseline, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Assessed Procedural and Post-Procedural Pain Levels | The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable. | During injection, immediately following injection, 15, 30, and 45 min post-injection | 
| Subject's Global Assessment of Change in Appearance of Perioral Lines | The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse. | Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6 |