Combination Facial Aesthetic Treatment in Millennials
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- FACE-Q Satisfaction With Facial Appearance Overall Scale
研究概览
简要总结
With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers worldwide expecting to invest in aesthetic treatments in the upcoming year, it is imperative to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a millennial cohort. The investigators hypothesize that a combination approach to facial aesthetic treatment in a millennial cohort will result in increased patient-reported satisfaction in multiple areas, including perception of aging concerns and quality of life.
详细描述
This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation (i.e., born between January 1, 1981 and December 31, 1996)1 and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure, with an optional touch-up treatment at 2 weeks. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. Other outcome measures include various FACE-Q Aesthetic scales, digital skin imaging analysis, photographs, and rater-blinded clinical assessment using the Global Aesthetic Improvement Scale (GAIS).
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
- 24 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Date of birth between January 1, 1981 and December 31, 1996
- •Naiveté to facial injections of botulinum toxin and dermal filler
- •Desire to receive all three facial cosmetic injectables in the study
- •Suitable candidate to receive facial injectables, as determined by clinician judgment
- •Provision of written informed consent for all study procedures
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Desire to receive only one or two of the facial injectables
- •Dermatologic or medical conditions at the injection sites that may be exacerbated by the study procedures (e.g., severe acne, active infection, open sores or lesions, history of cold sores)
- •Pre-existing cardiovascular disease (e.g., heart failure, coronary artery disease)
- •Pre-existing swallowing or respiratory disorders (e.g., dysphagia, asthma, COPD)
- •Peripheral motor neuropathy disease, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
- •Known hypersensitivity or allergies to any of the components of the administered drugs/devices in the study (e.g., Gram-positive bacterial proteins, lidocaine)
- •History of anaphylaxis or multiple severe allergies
- •History of a bleeding or coagulation disorder
- •Pregnant or breast-feeding
- •Current and/or scheduled use of the following medications: immunosuppressants, anticoagulants (e.g., warfarin, heparin, rivaroxaban), antiplatelets (e.g., clopidogrel, ticagrelor, NSAIDs), antibiotics (e.g., aminoglycosides), anticholinergics, muscle relaxants
- •Procedures or treatments to the face in the past 14 days (e.g., chemical peel, laser surgery, microdermabrasion)
- •Plan to undergo elective cosmetic procedure on the face (e.g., laser surgery, plastic surgery, physician-strength chemical peel) during the study
- •Any medical condition(s) that could be compromised by participating in the study
研究组 & 干预措施
Facial aesthetic treatment
Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks.
干预措施: Botox Cosmetic Injectable Product (Drug)
Facial aesthetic treatment
Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks.
干预措施: Juvéderm Voluma XC (Device)
Facial aesthetic treatment
Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks.
干预措施: Juvéderm Volbella XC (Device)
结局指标
主要结局
FACE-Q Satisfaction With Facial Appearance Overall Scale
时间窗: Baseline and 2 months after the procedure
To assess changes in patient's satisfaction with their appearance following a combination facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. This tool consists of several questions. For each question, the study participant selects a number from 1 to 4. Higher number are associated with higher satisfaction with facial appearance. The raw scores of the primary outcome measure were transformed by the Rasch measurement method into a 0-to-100 point scale.
次要结局
- FACE-Q Satisfaction With Lips(Baseline and 2 months after the procedure)
- FACE-Q Appraisal of Lines Overall(Baseline and 2 months after the procedure)
- FACE-Q Expectations Scale(At baseline)
- FACE-Q Social Function Scale(Baseline and 2 months after the procedure)
- FACE-Q Patient-Perceived Age Visual Analogue Scale(Baseline and 2 months after the procedure)
- FACE-Q Satisfaction With Cheeks(Baseline and 2 months after the procedure)
- FACE-Q Satisfaction With Outcome Scale(2 months after the procedure)
- FACE-Q Psychological Function Scale(Baseline and 2 months after the procedure)
- FACE-Q Aging Appraisal Scale(2 months after the procedure compared to baseline)
研究者
Jared Jagdeo, MD, MS
Associate Professor of Dermatology
State University of New York - Downstate Medical Center