A Randomized, Multicenter, Double-blinded, Placebo Controlled, Split-Face Study Evaluating Procedure Pairing of a Peptide Anti-Aging Serum With Onabotulinumtoxin A in the Treatment of Periorbital Facial Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Tolerability Scores
研究概览
简要总结
This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate the procedure-pairing of OnabotulinumtoxinA with a peptide anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and radiance of the face after 12 weeks of twice-daily use in female subjects ages 35 - 60 as compared to placebo. A total of 29 subjects completed study participation.
详细描述
This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate procedure pairing of a peptide anti-aging serum with Onabotulinumtoxin A in the treatment of periorbital facial wrinkles when used over the course of 12 weeks by women with moderate to severe crow's feet wrinkles and fine lines, and mild to moderate photoaging.
Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for wrinkles, fine lines, and skin appearance will be graded at rest and at maximum smile for each side. Investigator and subject tolerability, self-assessment questionnaire and VISIA photography will be completed at baseline, weeks 4, 8 and 12.
A total of 29 subjects completed study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Subjects left and right face (split face) will be randomly assigned to one of the following treatment arms: peptide antiaging serum vs placebo serum. The active and placebo will be placed in the same container and labelled Right and Left. Double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety are blinded to treatment during the twelve week randomization study. The investigational product will be identical in appearance to placebo and both will be packaged in the same container, which will be labelled Right and Left corresponding to the randomization.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects must be between 35-60 years of age.
- •Female subjects of childbearing potential must be willing to use a form of birth control during the study.
- •Subjects with Fitzpatrick I-VI photo skin type.
- •Subjects must have moderate to severe crow's feet facial wrinkles (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
- •Subjects must have moderate to severe crow's feet fine lines (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
- •Subjects may have mild to moderate photo-aging (score 3-6 on 0-9 scale) secondary to physiologic aging, hormonal influences, and environmental stressors.
- •Subjects must have no skin disease in the facial area being evaluated.
- •Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- •Subjects must be willing to provide verbal understanding and written informed consent
排除标准
- •Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- •Subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the Investigator.
- •Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin.
- •Subjects who are unwilling or unable to comply with the requirements of the protocol.
结局指标
主要结局
Tolerability Scores
时间窗: 12 weeks
The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in scores or lack of significant change at Day 28, Day 56, and Day 84 in comparison to baseline indicates tolerability / safety of the test material. Four point scale with a lower score indicating a better outcome. 0 = None 1. = Mild 2. = Moderate 3. = Severe
Incidence of Adverse Events
时间窗: 12 weeks
The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediate post-procedure and through-out the length of the study.
Clinical Efficacy Grading by Griffith's Scale
时间窗: 12 weeks
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10 point scale. A change in scores at Day 28, Day 56, and Day 84 (+/- 3 days) in comparison to baseline indicates an improvement for the indicated parameter. The efficacy parameters will be assessed at rest and at maximum smile and at specific areas on both the left and right sides of the subjects face using a modified Griffith's 10 point scale according to the following numerical definitions (half point scores may be used as necessary to more accurately describe skin conditions) 0 = None (best possible condition) 1 to 3 = Mild 4 to 6 = Moderate 7 to 9 = Severe (worst possible condition). The lower the score equates to the best possible outcome.
次要结局
- Secondary Tolerability Scores(12 weeks)
- Self-Assessment Questionnaire(12 weeks)