NCT03319719已完成不适用
Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- Mean Pain Using Visual Analog Scale (VAS)
研究概览
简要总结
Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs.
Identify and describe adverse events (AEs) and serious adverse events (SAEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has right and left NLF ratings of 2 or 3 (moderate or severe) on the Merz NLF Scale, as determined by the blinded evaluator.
- •Has the same Merz NLF Scale rating on both NLFs (i.e., symmetrical NLFs).
- •Is at least 18 years of age.
- •Understands and accepts the obligation not to receive any other procedures (i.e., dermal fillers, toxin treatments, facial ablative or fractional laser, microderm abrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage], or surgical procedures) below the orbital rim on the face during study participation.
排除标准
- •Had prior surgery in the mid- and/or lower-face area, including the nasolabial fold(s), or has a permanent implant or graft in the mid- and/or lower-face area that could interfere with effectiveness assessments. (NOTE: Rhinoplasty is permitted if the procedure was ≥ 12 months prior to study enrollment.)
- •Has skin or fat atrophy, beyond typical for the subject's age, in the mid- to lower-facial region or has been diagnosed with a connective tissue disorder.
- •Has unphysiological skin laxity or sun damage, beyond typical for the subject's age, or subject plans to tan during the study period.
- •Has undergone oral surgery (e.g., orthodontia, extraction, implants) in the past 30 days or plans to receive such surgery during participation in the study.
- •Has received mid- and/or lower-facial region treatments with porcine-based collagen fillers, Belotero® Volume, JUVÉDERM VOLUMA®, Restylane® Lyft, RADIESSE®, poly L-lactic acid (PLLA), or mesotherapy within the past 24 months and/or with other hyaluronic acid (HA) products within the past 12 months or plans to receive such treatment during participation in the study.
- •Has ever been treated with fat injections or permanent and/or semi-permanent dermal fillers in the mid- and/or lower-facial region or plans to receive such treatment during participation in the study.
- •Has received immunosuppressive medications or systemic steroids (except intranasal/inhaled steroids) in the past 2 months or plans to receive such treatment during participation in the study.
- •Has an acute inflammatory process or infection at the injection site (e.g., skin eruptions such as cold sores, cysts, pimples, acne, eczema, hives, streptococcus infections) or history of chronic or recurrent infection or inflammation with the potential to interfere with study results or increase the risk of AEs.
- •Has a history of allergic/anaphylactic reactions, including hypersensitivity to lidocaine or anesthetics of the amide type, hyaluronic acid preparations, gram positive bacterial proteins, or any of the device components.
- •Has a known bleeding disorder or has received or is planning to receive anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs [e.g., aspirin, ibuprofen]), or other substances known to increase coagulation time (e.g., vitamins or herbal supplements, i.e., Vitamin E, garlic, gingko) from 10 days before injection to 3 days after injection.
- •Has any other medical condition with the potential to interfere with study outcome assessments or compromise subject safety (i.e., increase the risk of adverse events).
研究组 & 干预措施
Belotero® Balance with integral lidocaine
Experimental
Belotero® Balance with integral lidocaine will be injected in one of the two NLF (split-face study design: treatment side will be randomized)
干预措施: Belotero® Balance with integral lidocaine (Device)
Belotero Balance without lidocaine
Active Comparator
Belotero Balance without lidocaine will be injected in one of the two NLF (split-face study design: treatment side will be randomized)
干预措施: Belotero® Balance (Device)
结局指标
主要结局
Mean Pain Using Visual Analog Scale (VAS)
时间窗: Day 1
Pain was assessed using a using a 10 centimeter (cm) VAS. It included 21-numbered circles at 0.5 cm increments, spanning 10 cm total, and was anchored by word descriptors. The VAS scores ranged from 0 (no pain) to 10 (very severe pain).The level of pain was evaluated for each NLF independently immediately upon completion of injection (time zero) on Day 1.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Baseline up to Week 6)
- Percentage of Responders With Greater Than or Equal to (>=) 1-point Improvement as Evaluated Using Merz NLF Scale at Week 6(Week 6)
- Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries(Baseline up to Week 6)
- Number of Participants With Incidence of Any Common Treatment Site Response (CTR) Evaluated Using Participant Diaries(Baseline up to Week 6)
- Number of Participants With Incidence of Any CTR by Severity Evaluated Using Participant Diaries(Baseline up to Week 6)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital HollowVolume Loss in the Infraorbital Hollow AreaNCT04594239Merz North America, Inc.150
已完成
3 期
Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® SoftFacial WrinklesNCT00877279Merz North America, Inc.64
已完成
4 期
Reduction of Bladder Injection Pain With Belladonna Opiate SuppositoryUrinary Urge IncontinenceUrinary Bladder, NeurogenicPainful Bladder SyndromeOveractive BladderNCT02600715Edgar LeClaire, MD26
Unknown
不适用
Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound GuidanceMandibular DysfunctionNCT04900324Centre Hospitalier Universitaire de Besancon48
已完成
2 期
A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung CancerSmall Cell Lung CancerNCT01497873Chong Kun Dang Pharmaceutical164