An Open Label Cosmetic Study to Evaluate the Safety and Efficacy of the Same-day Treatment of VI Peel® and Botox® for the Correction of Sun Damage, Fine Lines, and Wrinkles on the Face
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study is being conducted to improve standards of care in the cosmetic treatment of sun damage, fine lines, and wrinkles. VI Peels® and Botox® have been used cosmetically to improve patient concerns as monotherapies. This study seeks to confirm that the same-day combination creates no additional side-effects and furthermore that patient satisfaction is heightened as a result.
详细描述
This study seeks to utilize the mechanisms of action of both products to simultaneously address fine lines and wrinkles. VI Peels contain a synergistic blend of acids that produce keratolytic and kerato-coagulation qualities focused on desquamation and cellular renewal. The VI Peel blend contains Trichloroacetic Acid, Phenol, Salicylic Acid, Retinoic Acid and Ascorbic Acid. Botox containing Botulinum toxin type A is a purified substance, derived from a bacterium that block muscular nerve signals temporarily preventing the muscular contraction and subsequent wrinkle formation.
The expected benefit of this investigational combination include improvements to Standards of Care in relation to treatment of the cosmetic patient by establishing safety of the combination treatment, improving patient outcomes by simultaneously addressing sun damage, fine lines, and wrinkles through dual mechanisms, and overall improvement to patient satisfaction.
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
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Female and Males subjects of any race
- •Ages 30-70 Years old
- •Subjects who can read, understand, and sign the Informed Consent Form.
- •Subjects willing and able to comply with all study requirements, including return visits and photographs (eyes censored or uncensored).
排除标准
- •Is pregnant or lactating
- •Has an active infection on their face (excluding acne)
- •Has used Isotretinoin (Accutane) within the last six months
- •Has had chemotherapy or radiation treatments within the last six months
- •Has a history of neuromuscular disorders
- •Has a history of bleeding disorders
- •Has an allergy to albumin
- •Has an allergy to Aspirin
- •Has an allergy to Phenol
- •Has received the following treatments in the last 6 months:
- •botulinum toxin, soft tissue filler, medium to deep chemical peel, ablative laser, radio frequency treatment, ultrasound device treatment, non-ablative laser treatment
- •Is planning on receiving in the next 1months: soft tissue filler, medium to deep chemical peel, ablative laser, radio frequency treatment, ultrasound device treatment, nonablative laser treatment
- •Is unable to understand the protocol or to give informed consent
- •Not willing to comply with all study requirements including return visits and photographs (eyes censored or uncensored)
- •Has been diagnosed or is displaying COVID-19 symptoms -
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Day 7 (+/- 3)
To establish safety of the same-day combination of VI Peel \& Botox, the study will measure the rate and occurrence of Adverse Events as compared to a stand-alone treatment of Botox. Rate and occurrence of Botox as a stand-alone intervention will be based off of the package insert indicating each Adverse Event
次要结局
- Change to Facial Wrinkle Severity(Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention)
- Change to Uniformity of Pigment(Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention)
- Change to(Baseline, 7 (+/- 3) Days after Intervention, and 30 Days after Intervention)