The cumulative effects of aging, weight change, ergonomics (i.e., "tech neck"), and environmental exposures (i.e., 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 hyaluronic acid (HA) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin smoothness. The purpose of this study is to assess safety and effectiveness of VOLITE XC in adults seeking improvement in neck appearance. VOLITE XC is an investigational product intended to reduce horizontal neck lines for improvement of neck appearance. Participants are placed in 1 of 2 groups, called treatment arms. Participation will be randomized in a 2:1 ratio in treatment and control arms. Up to 212 adult participants with moderate or severe transverse neck lines will be enrolled in the study at up to 20 sites. Participants in the treatment group will receive VOLITE XC at Day 1 and be 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 be 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
159
Steve Yoelin MD Medical Associate Inc /ID# 239072
Newport Beach, California, United States
Laser & Skin surgery Medical group, Inc /ID# 241999
Sacramento, California, United States
Cosmetic Laser Dermatology /ID# 239121
San Diego, California, United States
Art of Skin MD /ID# 239071
Solana Beach, California, United States
Center for Dermatology and Dermatologic Surgery /ID# 239137
Washington D.C., District of Columbia, United States
Hevia Cosmetic Dermatology /ID# 239118
Coral Gables, Florida, United States
Skin Research Institute LLC /ID# 239109
Coral Gables, Florida, United States
Research Institute of the Southeast, LLC /ID# 239070
West Palm Beach, Florida, United States
Delricht Research /ID# 242001
New Orleans, Louisiana, United States
Rkmd, Llc /Id# 239075
North Bethesda, Maryland, United States
...and 5 more locations
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)
ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme). A "responder" is a participant with at least 1-grade improvement on the ATNLS.
Time frame: Month 1
Number of Participants With Treatment-Emergent 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.
Time frame: Baseline to end of study (up to 14 Months)
Percentage of Participants Achieving "Responder" Status for EI's Assessment of Global Aesthetic Improvement on the Neck Using the Global Aesthetic Improvement Scale (GAIS)
GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse). A "responder" is a participant who shows improvement in the overall aesthetic assessment on the neck using GAIS.
Time frame: Month 1
Change From Baseline to Month 1 in the Rasch-transformed Scores on FACE-Q Appraisal of the Neck Questionnaire
FACE-Q is a 10-item questionnaire assessing various aspects of the neck appearance. In the FACE-Q Appraisal of the Neck questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100. A higher score indicates greater satisfaction with facial appearance.
Time frame: Baseline to 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).
Time frame: Month 1
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