NCT01970397已完成不适用
A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of JUVEDERM® Ultra XC Injectable Gel Versus Belotero Balance® for Perioral Lines
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
研究概览
简要总结
A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have moderate to severe perioral lines as assessed by the Investigator using the 4-point POLSS (none, mild, moderate, and severe)
- •Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not study related
排除标准
- •Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
- •Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the perioral area, as judged by the Treating Investigator
- •Have a history of skin cancer
- •Is an active smoker
- •Has noticeable acne scarring, active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth area
- •Have had an active oral herpes or cold sore within 12 months
- •Have undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study
- •Have undergone cosmetic facial or perioral area procedures [e.g., face-lift, or other surgeries which may alter the appearance of the perioral area, including tissue grafting, or tissue augmentation with silicone, fat, or other permanent fillers] or be planning to undergo any of these procedures at any time during the study
- •Have undergone temporary or semi-permanent facial dermal filler injections (e.g., hyaluronic acid, calcium hydroxylapatite, L-Polylactic acid) in the lower face (below the orbital rim) within 24 months
- •Have received mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study other than study related procedures.
- •Have begun use of any new over-the-counter or prescription, oral or topical, antiwrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study. [NOTE: Use of sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrollment]
- •Have had epilation (e.g. laser hair removal, electrolysis, threading, etc.) in the perioral area performed within 3 months
- •Have received treatment with botulinum toxin of any serotype for any indication in the lower face [below the infraorbital rims (IORs)] within 1 year of the baseline visit
结局指标
主要结局
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
时间窗: Baseline, Month 6
The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.
次要结局
- Participant Assessed Procedural and Post-Procedural Pain Levels(During injection, immediately following injection, 15, 30, and 45 min post-injection)
- Subject's Global Assessment of Change in Appearance of Perioral Lines(Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6)
研究者
研究点 (1)
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