NCT07344584进行中（未招募）不适用
A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles in the Cheek Area
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Galderma R&D
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Number of Participants With all Adverse Events (AEs)
研究概览
简要总结
The primary objective of the study is to evaluate the safety of GP0122 and GP0124 for the correction of lines and wrinkles in the cheek area.
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
- None
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
- •Adult males or non-pregnant, non-breastfeeding adult females.
- •Participants with a GCWS At Rest score of Moderate or Severe on EACH side of the face, or Participants with a CSQS-CL score of Moderate, Severe, or Very severe on EACH side of the face.
- •Intent to undergo treatment for correction of lines and wrinkles in the cheek region.
- •Willing to abstain from any other facial plastic, surgical or cosmetic procedures in the cheek area for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
- •Inclusion criteria 4-5 apply only to female participants of childbearing potential:
- •Agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at screening, baseline and prior to receiving any study treatment.
- •Negative UPT at the screening and baseline visits.
排除标准
- •Known/previous allergy or hypersensitivity.
- •Known/previous allergy or hypersensitivity to local anesthetics.
- •Previous facial surgery (e.g., facelift) in the treatment area that in the Treating Investigator´s opinion.
- •Any previous aesthetic procedures or implants in the treatment area.
- •Presence of any disease or lesions in the treatment area.
- •An underlying known disease, a surgical or medical condition that would expose the participant to undue risk.
- •Use of concomitant medication that have the potential to prolong bleeding times.
- •Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol.
- •Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
研究组 & 干预措施
GP0122
Active Comparator
Participants will receive GP0122 in the cheek area at baseline with an optional touch-up session 1 month after the initial session.
干预措施: GP0122 (Device)
GP0124
Active Comparator
Participants will receive GP0124 in the cheek area at baseline with an optional touch-up session 1 month after the initial session.
干预措施: GP0124 (Device)
结局指标
主要结局
Number of Participants With all Adverse Events (AEs)
时间窗: From Day 1 up to last visit (Up to 12 months)
Number of Participants With Post-Treatment Responses as Assessed Using Subject Diary Data
时间窗: From Day 1 up to Day 28
Participant's Pain Assessment Using Numeric Pain Scale (NPS) Immediately Post Treatment and 30 Minutes Post Treatment
时间窗: Immediately and 30 minutes after each treatment
次要结局
- Responder Rates Based on the Treating Investigator's Live Assessment of the GCWS at Rest at Months 3, 6, 9 and 12(At Months 3, 6, 9 and 12)
- Responder Rates Based on the Treating Investigator's Live Assessment of the CSQS-CL at Rest at Months 3, 6, 9 and 12(At Months 3, 6, 9 and 12)
研究者
研究点 (5)
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