Evaluation of Skin Quality Improvement When Hyper-Diluted OnabotulinumtoxinA (Botox®, Botox® Cosmetic /BTXa/) is Injected Into The Superficial Dermis of the Mid-Face
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percent Improvement in Skin Quality
研究概览
简要总结
The purpose of this study is to comprehensively investigate and objectively demonstrate the effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more specifically evenness of skin tone, reduction of pore size and improvement in the appearance of preexisting skin scars.
详细描述
The purpose of this study is to comprehensively investigate and objectively demonstrate the effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more specifically evenness of skin tone, reduction of pore size and improvement in the appearance of preexisting skin scars. The ability of hyperdilute Botox® Cosmetic to improve overall skin quality is likely optimized when it is injected uniformly in hyper-diluted small aliquots in order to "saturate" the dermis. We propose to prepare Botox® Cosmetic in a manner that is approximately 4 times more dilute compared to the typical Botox® Cosmetic preparation. A 4x4 centimeter area located in the mid-cheek adjacent to the nose will be injected with hyperdilute Botox® Cosmetic. Botox® Cosmetic is not FDA-approved for this use. A maximum of 15 subjects will participate in this study, all of whom will receive injections of Botox® Cosmetic during the course of this study.
This study is a randomized, placebo-controlled, and double-masked study. This means neither the study doctor nor participant know the experimental agent (e.g., 0.9% saline solution and hyperdiluted Botox® Cosmetic) injected on each side of the patients' faces. The study will last for a total of 75 days. Evaluation of the study is based on the analysis of photographic images obtained during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to follow study instructions and likely to complete all required visits
- •Written consent has been obtained
- •Written authorization for "Use and Release of Health and Research Study Information" has been obtained
- •Subjects who are Fitzpatrick Skin Types II-IV
排除标准
- •Subjects must be Onabotulinum Toxin Type A naive; if subject has had Onabotulinum Toxin Type A administered in the face in the previous 12 months they are excluded
- •Subjects must be dermal filler naïve in the lateral canthal region and midface regions
- •Subjects must be energy or light device naïve
- •Subjects must have average or below-average lifetime sun exposure
- •Subjects must be free of inflammatory skin disease(s)
研究组 & 干预措施
Group B
Group B will be treated with 0.9% saline solution on day 1 and on day 30 they will be treated with Hyper-Diluted Botox.
干预措施: Topical anesthesia (Drug)
Group B
Group B will be treated with 0.9% saline solution on day 1 and on day 30 they will be treated with Hyper-Diluted Botox.
干预措施: 0.9% saline solution (Other)
Group A
Group A will be treated with Hyper-Diluted Botox on day 1 and on day 30 they will be treated with 0.9% saline solution.
干预措施: Hyper-Diluted Botox (Drug)
Group A
Group A will be treated with Hyper-Diluted Botox on day 1 and on day 30 they will be treated with 0.9% saline solution.
干预措施: Topical anesthesia (Drug)
Group A
Group A will be treated with Hyper-Diluted Botox on day 1 and on day 30 they will be treated with 0.9% saline solution.
干预措施: 0.9% saline solution (Other)
Group B
Group B will be treated with 0.9% saline solution on day 1 and on day 30 they will be treated with Hyper-Diluted Botox.
干预措施: Hyper-Diluted Botox (Drug)
结局指标
主要结局
Percent Improvement in Skin Quality
时间窗: Entire duration of the study (Day 1-Day 135)
An evaluation of the percent improvement in skin quality when the "Onabotulinum Toxin Type A" treated side of face is compared to the "placebo" treated side of the face. Good skin quality is defined as small pore size, evenness of skin texture, evenness of skin tone, minimal presence of wrinkles, and minimal presence of scars. We will measure improvement primarily by image analysis of the photos taken during each visit using the Canfield Scientific camera (or the Allergan provided alternative).
次要结局
- Patient and Investigator Reported Outcomes(Entire duration of the study (Day 1-Day 135))