A Post-Market, Randomized, Placebo-Controlled Study to Assess the Efficacy of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- C-GAIS by the PI or Designee
研究概览
简要总结
The primary objective of this study is to determine the efficacy of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max skin care products in subjects who undergo full facial rejuvenation, with a botulinum neurotoxin A and/or hyaluronic acid filler, in improving the appearance of the skin, patient satisfaction with aesthetic appearance, and the projected first impressions.
The secondary objective of this study is to examine patient satisfaction with the continuous use of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max products.
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
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is a female between the ages of 21 and 60;
- •Subject requires a full facial rejuvenation with a HA soft tissue filler and/or botulinum neurotoxin, per judgment of the PI or designee;
- •Subject is willing and able to provide written informed consent prior to the performance of any study related procedure;
- •Subject is willing and able to comply with the protocol requirements; and
- •Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup.
排除标准
- •Subjects who have received any facial filler in the 12-month or neurotoxin treatments in the 4-month period prior to enrollment;
- •Previous treatment with any resurfacing facial aesthetic procedure (e.g. deep chemical peeling and laser treatments) within the 12-month period prior to enrollment;
- •Previous treatment with photo rejuvenation therapy within the 6-month period prior to enrollment;
- •Subjects who plan to undergo facial cosmetic surgery or any aesthetic procedure (e.g. neurotoxins, dermal fillers, laser treatments, and chemical peels), which are not specified in this protocol, during the course of the study;
- •A known allergy or sensitivity to any component of the study ingredients;
- •Use of systemic steroids or anticoagulation medications;
- •Subjects with a history of bleeding disorders;
- •Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies;
- •Subjects with hypersensitivity to botulinum neurotoxin;
- •Subject with allergies to gram positive bacterial proteins;
- •Sensitivity to sulfides;
- •Subjects with allergy to cow's milk protein;
- •Subjects with previous history of sensitivity to amide type local anesthetics;
- •Subject with surgical alterations to the facial anatomy or marked facial asymmetry;
- •Inflammation or infection at the injection site(s);
- •Subjects with a history of eyelid or eyebrow ptosis;
- •Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin;
- •Subjects with neuromuscular disorders;
- •Use of anticholinergic, aminoglycosides or other agents that interfere with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants;
- •Subjects with immunodeficiencies such as HIV, lupus, scleroderma, and systemic infections;
- •Pregnant, nursing, or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence);
- •Current history of chronic drug or alcohol abuse;
- •Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product;
- •Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and
- •Enrollment in any active study involving the use of investigational devices or drugs.
结局指标
主要结局
C-GAIS by the PI or Designee
时间窗: Approximately 3 months from the baseline visit
Global aesthetic improvement in subjects is assessed by the PI/designee using the Global Aesthetic Improvement Scale (C-GAIS). Clinical-Global Aesthetic Improvement Scale (C-GAIS): 3 (Very Much Improved) 2 (Much Improved) 1 (Improved) 0 (No change) -1 (Worse) Scores closer to 3 show a more favorable outcome Scores closer to -1 show a less favorable outcome
SQA by the PI or Designee
时间窗: Approximately 3 months from the baseline visit
The quality of subjects' skin is assessed by PI/designee using the Skin Quality Assessment (SQA) Skin Quality Assessment (SQA): Tone (dyschromia) 0 - severe unevenness 1- moderate to severe unevenness 2 - moderate unevenness 3 - mild unevenness 4 - even Elasticity (Firmness) 0 - Very poor elasticity 1. \- poor elasticity 2. \- fair elasticity 3. \- good elasticity 4. \- firm Texture (Smoothness) 0 - severe 1. \- moderate to severe 2. \- moderate 3. \- mild 4. \- none Radiance 0 - severe dullness 1. \- moderate to severe dullness 2. \- moderate dullness 3. \- mild dullness 4. \- radiant All scores with a higher number indicate favorable results All scores with a lower number indicate less favorable results
次要结局
- Face-Q by Subjects(Final assessment is approximately 3 months from the baseline visit)
- FIQ by Blinded Evaluators(At the conclusion of study assessments (approximately 3 months from the baseline visit))
- SSES by Subjects(Final assessment is approximately 3 months from the baseline visit)