NCT02195427已完成不适用
A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA Global Action and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC in the Treatment of Moderate to Severe Nasolabial Folds
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Teoxane SA
- 入组人数
- 148
- 试验地点
- 5
- 主要终点
- Non-inferiority of the Delta of TEOSYAL® RHA GA and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE).
研究概览
简要总结
The purpose of this study is 1) to compare the effectiveness and safety of TEOSYAL® RHA Global Action versus Juvéderm® Ultra XC, and 2) to compare the effectiveness and safety of TEOSYAL® RHA Deep Lines versus Juvéderm® Ultra XC, in the treatment of moderate to severe nasolabial folds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient, male or female of any race, 22 years of age or older; female subjects of childbearing potential must have a negative urine pregnancy test and practice a reliable method of contraception
- •NLFs classified as WSRS grade 3 or 4 (same score for each side)
- •Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
- •Able to follow study instructions and likely to complete all required visits;
- •Signed informed consent and HIPAA (Health Insurance Portability and Accountability Act) form
排除标准
- •Female subjects that are pregnant or breast-feeding, or of childbearing potential and not practicing reliable birth control
- •Known hypersensitivity/allergy to any component of the study devices
- •Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, history of anaphylactic shock
- •Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
- •Clinically significant active skin disease within 6 months
- •History of active chronic debilitating systemic disease
- •History of connective tissue disease
- •History of malignancy (excl. non-melanoma skin cancer) within past 5 years
- •History of bleeding disorders
- •Need for clinically significant and continuous medical treatment within 2 weeks prior to first visit
- •Received/used a prohibited treatment/procedure within certain time periods (e.g., bioresorbable fillers, NSAIDS, acetylsalicylic acid, high dose vitamin E, corticosteroids, interferon, anti-coagulation therapies, laser/light therapies, botulinum toxin injections (frontalis and glabella complex treatment permitted), prescription strength topical retinoids, facial peels, excisional facial surgery, clinically significant oral or maxillofacial surgery)
- •Clinically significant alcohol or drug abuse, or history of poor cooperation, non-compliance with medical treatment, or unreliability
- •Exhibit a physical attribute(s) that may prevent assessment or treatment of NLFs such as excessive facial hair, traumatic or surgical facial scars, and/or excessive hyperpigmentation in the treatment areas
- •A condition or situation that may put the subject at significant risk, confound the study results, or significantly interfere with the subject participation
研究组 & 干预措施
TEOSYAL RHA Global Action/Juvederm Ultra XC
Experimental
Split-face injection of TEOSYAL® RHA Global Action into one NLF and Juvederm® Ultra XC into the contralateral NLF (n=75). Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
干预措施: TEOSYAL® RHA Global Action (Device)
TEOSYAL RHA Deep Lines/Juvederm Ultra XC
Experimental
Split-face injection of TEOSYAL® RHA Deep Lines into one NLF and Juvederm® Ultra XC into the contralateral NLF (n=75). Up to 3.0 mL injected per NLF (mid-dermis to deep-dermis). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
干预措施: TEOSYAL® RHA Deep Lines (Device)
结局指标
主要结局
Non-inferiority of the Delta of TEOSYAL® RHA GA and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE).
时间窗: Baseline and 24 weeks after last treatment
TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' BLE = Blinded Live Evaluator
次要结局
- Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE).(Weeks 24, 36, 52, 64)
- Number of Subjects Receiving Touch-up Treatment.(Week 2)
- Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).(During 14 days after initial treatment (D0) and touch-up (2 weeks))
- Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI(Baseline and Weeks 2, 4, 12, 24, 36, 52, 64)
- Subject's Satisfaction Score(Weeks 2, 4, 12, 24, 36, 52, 64)
- Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE(Baseline and Weeks 24, 36, 52, 64)
- Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.(Weeks 4, 12, 24, 36, 52, 64)
- Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire(Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64)
- Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).(During Injection and 5, 15, 30 minutes post-injection)
- Delta of the WSRS Score Between W24,36,52 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the BLE(Baseline and Weeks 24, 36, 52, 64)
- Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI(Baseline and Weeks 2, 4, 12, 24, 36, 52, 64)
- Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)(Week 2)
- Number of Subjects Receiving Re-treatment(Weeks 24, 36, 52, 64)
研究者
研究点 (5)
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