A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 6
- 主要终点
- Change From Baseline in Lip Fullness Grading Scale
研究概览
简要总结
To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
详细描述
This is a multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with PN40082
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
盲法说明
Open Label
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., met all inclusion/
排除标准
- •; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2, and had no significant protocol violations that would affect the treatment evaluation.
- •If female and of childbearing potential, a negative urine pregnancy test at Visit 1/Day 1 and the subject agrees to use adequate contraception during the study period
- •Willing to give written informed consent
- •Exclusion Criteria:
- •Women who are pregnant, lactating, or planning a pregnancy
研究组 & 干预措施
PN40082
All subjects in this study will receive one open-label treatment with PN40082.
干预措施: PN40082 (Device)
结局指标
主要结局
Change From Baseline in Lip Fullness Grading Scale
时间窗: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
Lip Fullness Grading Scale is a validated 5-point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 full lips (best outcome)
Change From Baseline in Perioral Lines Severity Scale
时间窗: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
Change from baseline in the perioral lines rating scale (POL), a 4 point rating scale with 0 as a mouth with no perioral lines (better outcome) to 3 a mouth with many deep lines or crevices (worse outcome).
次要结局
- Number of Participants With Patient Global Aesthetic Improvement(Visit 1/Day 1 to Visit 3/Month 2, 56 days)
- Number of Participants With Investigator Global Aesthetic Improvement(Visit 1/Day 1 to Visit 3/Month 2, 56 days)
- Number of Subjects With Decreased Swelling(Visit 1/Day 1 to Visit 3/Month 2, 56 days)