A Study to Assess Adverse Events and Change in Disease Activity of JUVÉDERM® VOLITE™ XC Injectable Gel for Change in Neck Appearance in Adult Participants

Study Overview
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Brief Summary
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The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The neck is a frequently mentioned area by patients complaining about its crepey texture and deep lines. VOLITE XC is a crosslinked HA gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin quality. The purpose of this study is to assess adverse events and effectiveness of VOLITE XC in adults seeking improvement in neck appearance. VOLITE XC is an investigational product being developed for the improvement of horizontal neck lines. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 212 adult participants with transverse neck lines will be enrolled in the study at approximately 20 sites. Participants in the treatment group will receive VOLITE XC at Day 1 and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period. The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and followed for 6 Months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Official Title
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Multicenter, Evaluator-blinded, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance

Conditions
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Neck Lines

Intervention / Treatment
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* Device: VOLITE XC
* Device: VOLITE XC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in general good health as determined by Treating Investigator's judgment, including no known active pandemic infection. Participants seeking improvement of transverse neck lines. Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment. Exclusion Criteria: Neck deformity or significant skin laxity with severe redundant folds. Significant skin pigmentation disorders or discoloration in the neck area that would interfere with the visual assessment of the neck area. Current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the neck. Tendency to develop hypertrophic scarring. History of thyroid cancer, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area. Permanent soft tissue fillers in the neck area. Semi-permanent soft tissue fillers in the neck area within 2 years before enrollment. HA fillers or autologous fat in the neck area within 12 months before enrollment. Mesotherapy, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, microneedling, laser, or other cosmetic procedures in the neck area within 12 months before enrollment. Botulinum toxin in the neck area within 6 months before enrollment. Deoxycholic acid injections or cryolipolysis in the submentum area within 6 months before enrollment. Neck surgeries and procedures. Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments. Pregnant, nursing or planning a pregnancy.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VOLITE XC<br>Participants will receive VOLITE XC for initial treatment and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period. | Device: VOLITE XC<br>* Intradermal Injection<br>* Other names: JUVÉDERM® VOLITE™ XC;Device: VOLITE XC<br>* Subdermal Injection<br>* Other names: JUVÉDERM® VOLITE™ XC;|
| Other: Control Group<br>The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and followed for 6 Months. | Device: VOLITE XC<br>* Intradermal Injection<br>* Other names: JUVÉDERM® VOLITE™ XC;Device: VOLITE XC<br>* Subdermal Injection<br>* Other names: JUVÉDERM® VOLITE™ XC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Responder status based on Evaluating Investigator's (EI) live assessment of transverse neck lines using the Allergan Transverse Neck Lines Scale (ATNLS) | A responder is a participant with at least 1-grade improvement on the ATNLS. ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme) | Month 1 | 
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. | Up to 14 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Responder Status for EI's Assessment of global aesthetic improvement on the neck using the Global Aesthetic Improvement Scale (GAIS) | A responder is a participant who shows improvement in the overall aesthetic assessment on the neck using GAIS. GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse). | Month 1 | 
| Percentage of Participants Achieving Responder Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS | A responder is a participant who shows improvement in the overall aesthetic assessment in the neck using GAIS. GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse). | Month 1 | 
| Change from baseline to Month 1 on FACE-Q Appraisal of Neck Lines questionnaire | FACE-Q is a 10-item questionnaire assessing various aspects of the neck appearance. In the FACE-Q Appraisal of Neck Lines questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100. | Baseline to Month 1 |