Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 116
- 主要终点
- Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
研究概览
简要总结
A study to evaluate patient satisfaction, aesthetic and psychological impact of combined treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Qualified to receive treatment with BOTOX® Cosmetic, a facial filler (JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA Plus XC and/or JUVÉDERM® VOLUMA® XC) and LATISSE® treatment
- •Naïve to botulinum toxin therapy of any serotype for any indication
- •Naïve to prescription eyelash growth products of any type
- •Naïve to dermal filler treatment in the face and neck
排除标准
- •Undergone facial plastic surgery, tissue grafting, tissue augmentation or facial dermal filler injections
- •Had laser, photomodulation, intense pulsed light, radio frequency, dermabrasion or chemical peel in the face or neck
- •Have received skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 3 months
- •Systemic retinoid therapy within 1 year prior to study enrollment
- •Presence of inflammation at the proposed injection site(s)
- •Profound atrophy/excessive weakness of muscles in target areas of injection
- •Known immunization or hypersensitivity to any botulinum toxin serotype
- •Undergone oral surgery or dental procedures within 30 days
- •No visible eyelashes
- •Use of permanent eyeliner, eyelash implants, semi-permanent eyelash tint, dye or extension
- •Use of prescription eyelash growth products
- •Unwilling or unable to remove contact lenses prior to study medication application in the evening and keep lenses out for 30 minutes
- •Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
研究组 & 干预措施
All Participants
JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
干预措施: onabotulinumtoxinA (Biological)
All Participants
JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
干预措施: bimatoprost ophthalmic solution 0.03% (Drug)
All Participants
JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
干预措施: JUVÉDERM® ULTRA XC (Device)
All Participants
JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
干预措施: JUVÉDERM® ULTRA PLUS XC (Device)
All Participants
JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
干预措施: JUVÉDERM® VOLUMA® XC (Device)
结局指标
主要结局
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
时间窗: Baseline, Month 4
Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire. Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied. The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.
次要结局
- Change From Baseline in Aging Appearance Using a 7-item Questionnaire(Baseline, Month 4)
- Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)(Baseline, Month 4)
- Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire(Baseline, Month 4)
- Participant's Self- Perception of Age (SPA)(Baseline, Month 4)
- Change From Baseline in Social Confidence Using an 8-item Questionnaire(Baseline, Month 4)
- Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity(Baseline, Month 4)
- Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)(Baseline, Month 4)
- Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS(Baseline, Month 4)
- Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)(Baseline, Month 4)
- Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS(Baseline, Month 4)
- Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity(Baseline, Month 4)
- Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity(Baseline, Month 4)
- Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area(Baseline, Month 4)