A Prospective, Open-label Study to Evaluate Sequential Treatment With BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator
研究概览
简要总结
This study has been designed to evaluate the safety and effectiveness of sequential treatment with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline.
详细描述
Participants may be treated with up to 6 treatments with Belkyra, followed by treatment with Voluma. Participants will have opportunity to participation in a skin biopsy sub-study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 2 or above on Allergan Loss of Jawline Definition Scale (ALJDS)
- •Grade 2 or 3 on reported Clinician-Rated Submental Fat Rating Scale (CR-SMFRS)
- •Stable body weight for at least 26 weeks
- •Accept the obligation to forego any treatment or behavior (e.g., unshaven facial hair; significant changes to dietary or exercise habits) during the participants participation in the study that may affect the assessments of the submental area
排除标准
- •Grade 4 on Submental Skin Laxity Grade (SMSLG)
- •Grade 4 on Allergan Jowl Fat Rating Scale (AJFRS)
- •Body mass index (BMI) >35 kg/m^2
- •History of, or current symptoms of dysphagia
- •History of temporary, semi-permanent or permanent facial or neck dermal filler injections below the medial canthi at any time prior to treatment, or within 52 weeks before Screening for treatment above the medial canthi
- •History of facial and/or neck plastic surgery, tissue grafting or permanent facial implants anywhere in the face or neck
- •History of any intervention (e.g., liposuction, surgery, or lipolytic agents) to treat submental fat (SMF)
- •Evidence of any cause of enlargement in the submental area other than localized SMF
- •History of mesotherapy or ablative procedures to the face and/or neck 52 weeks before Screening
- •History of skin resurfacing in the neck or submental area within 26 weeks before Screening
- •Treatment with botulinum toxin injections in the neck or submental area within 26 weeks before Screening
- •Participants on prescription topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 26 weeks before Screening and who are unable to maintain regimen for the study
- •Systemic retinoid therapy within 52 weeks before Screening
- •Current use of oral corticosteroids
- •Is on a regimen of anticoagulation therapy (eg, warfarin, clopidogrel)
- •Has current injection site inflammatory or infectious processes, abscess, an unhealed wound, or a known cancerous or precancerous lesion in chin, masseter, or submental region
- •Planned oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 2 weeks prior to and after VOLUMA™ treatment
研究组 & 干预措施
BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
干预措施: BELKYRA® (Drug)
BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
干预措施: Juvéderm® VOLUMA™ with Lidocaine (Device)
结局指标
主要结局
Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator
时间窗: Baseline (Day 0) to Week 58
The ALJDS was an investigator assessment of loss of jawline definition measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. Data is reported for both sides of the face, right side of the face and left side of the face.
次要结局
- Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS(Baseline (Day 0) to Last Treatment (Up to Week 48))
- Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)(Baseline (Day 0) to Week 58)
- Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck(Baseline (Day 0) to Week 58)
- Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score(Baseline (Day 0) to Week 58)
- Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score(Baseline (Day 0) to Week 58)
- Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin(Baseline (Day 0) to Week 58)
- Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS)(Baseline (Day 0) to Week 58)
- Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images(Baseline (Day 0) to Week 58)