Evaluation of the Merz Jawline Grading Scale (MJGS) Following Radiesse (+)® Correction of Subcutaneous Volume Loss and Contour Deficits of the Jawline - a Canadian Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4
研究概览
简要总结
This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS) to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and FACE-Q instrument
详细描述
A prospective, open label study, in which both right and left jawlines will receive treatment with Radiesse (+). Subjects will be randomized in a 2:1 ratio to either a treatment group or an untreated control group. Jawlines will be assessed by masked evaluators on the MJGS. Treating physicians and treatment group subjects will assess satisfaction on the GAIS. Treatment group subjects will self-report aesthetic outcomes on the FACE-Q instrument.
Treatment subjects will be evaluated at enrollment, and 1, 2 and 4 weeks after enrollment. Control group subjects will be required to be evaluated at enrollment and 4 weeks after enrollment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has right and left jawlines with moderate to severe volume/contour loss as determined by a live, masked evaluator.
- •Is at least 18 years of age.
- •Understands and accepts the obligation not to receive any other procedures below the orbital rim including the neck during participation in the study.
- •Understands and accepts the obligation and is logistically able to present for all scheduled study visits and meet all study requirements.
排除标准
- •Has ever been treated with silicone, PMMA (polymethyl methacrylate), fat injections, poly-L-lactic acid (PLLA; Sculptra®) or permanent dermal fillers below the orbital rim including the neck.
- •Has had surgery on the jawbone or has surgical permanent implant to the face or neck.
- •Has bruxism, masseter muscle hypertrophy or asymmetry of masseter muscles, active temporomandibular joint (TMJ) disease or disorder, or active periodontal disease.
- •Has any medical condition with the potential to interfere with the study or increase the risk of adverse events.
- •Has undergone oral surgery recently or plans to undergo oral surgery procedures during participation in the study.
结局指标
主要结局
Percentage of Jawlines Achieving Greater Than or Equal to (>=) 1-point Improvement on Merz Jawline Grading Scale (MJGS) at Week 4
时间窗: Week 4
MJGS is a 5-point scale, where score ranges from (0-4) as, score 0: continuous jawline contour, no downshifting of subcutaneous volume; score 1: mild loss of jawline contour, mild downshifting of subcutaneous volume; score 2: moderate loss of jawline contour, moderate downshifting of subcutaneous volume; score 3: severe loss of jawline contour, severe downshifting of subcutaneous volume and score 4: very severe loss of jawline contour, diffuse mandibular angle, very severe downshifting of subcutaneous volume.
次要结局
- Treatment Group, Radiesse (+) Injectable Implant: Percentage of Jawlines With >=1-point Improvement on the MJGS Versus at Least an Improved Rating on Global Aesthetic Improvement Scale (GAIS) at Week 4(Week 4)