Multicenter, Evaluator-blinded, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 30
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) based on EI live assessment.
排除标准
- •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.
研究组 & 干预措施
Control Group
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.
干预措施: VOLITE XC (Device)
VOLITE XC
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.
干预措施: VOLITE XC (Device)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 14 Months
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.
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)
时间窗: Month 1
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)
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)
时间窗: Month 1
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.
Number of Participants With Treatment-Emergent Adverse Events
时间窗: Baseline to end of study (up to 14 Months)
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.
次要结局
- Percentage of Participants Achieving "Responder" Status for EI's Assessment of global aesthetic improvement on the neck using the Global Aesthetic Improvement Scale (GAIS)(Month 1)
- Percentage of Participants Achieving "Responder" Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS(Month 1)
- Change from baseline to Month 1 in the Rasch-transformed scores on FACE-Q Appraisal of the Neck questionnaire(Baseline to Month 1)
- Percentage of Participants Achieving "Responder" Status for EI's Assessment of Global Aesthetic Improvement on the Neck Using the Global Aesthetic Improvement Scale (GAIS)(Month 1)
- Change From Baseline to Month 1 in the Rasch-transformed Scores on FACE-Q Appraisal of the Neck Questionnaire(Baseline to Month 1)
- Percentage of Participants Achieving "Responder" Status for Participant's Assessment of Global Aesthetic Improvement on the Neck Using GAIS(Month 1)