NCT04177212已完成不适用
Prospective, Multicenter, Parallel-group, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of MRZF111 in the Treatment of décolleté Wrinkles
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 18
- 主要终点
- Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater
研究概览
简要总结
To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between ≥18 and ≤65 years old.
- •Décolleté wrinkles with a rating of moderate to severe (grade 2 to 3) on the MAS Décolleté Wrinkles-At Rest as determined by the blinded live rater and confirmed by the treating investigator afterwards.
排除标准
- •Any previous treatment with fat injections, poly L-lactic acid or permanent dermal fillers (e.g., silicone, polymethyl methacrylate) in the décolleté.
- •Any previous surgery, including plastic surgery, or surgical permanent implant in the décolleté or in the breasts that could interfere with effectiveness and safety.
- •Any previous thread lifting in the décolleté.
- •Previous treatment with collagen fillers, calcium hydroxylapatite (CaHa), and/or long-lasting hyaluronic acid (HA) fillers (e.g., Belotero® Intense/Volume, Juvéderm® Volift/Volbella) in the décolleté within the past 24 months before baseline.
- •Previous treatment with other HA fillers in the décolleté within the past 12 months before baseline.
- •Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels and/or non-invasive skin tightening (e.g., ultrasound, radiofrequency, intense pulsed light treatment) in the décolleté within the past 6 months before baseline.
结局指标
主要结局
Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater
时间窗: 16 weeks after the last treatment on Week 16 (at Week 32)
The percentage of responders (responder rate) was defined as greater than or equal to (\>=) 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at rest was assessed using MAS-at rest scale. The MAS-at rest scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome.
次要结局
- Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF)(16 weeks after the last treatment on Week 16 (at Week 32))
- Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE)(Up to Week 52)
- Percentage of Participants With Global Aesthetic Improvement Based on the Investigator's Global Aesthetic Improvement Scale on Décolleté Wrinkles (iGAIS-Wrinkles) as Assessed by the Treating Investigator (LOCF)(16 weeks after the last treatment on Week 16 (at Week 32))
- Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF)(16 weeks after the last treatment on Week 16 (at Week 32))
- Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF])(16 weeks after the last treatment on Week 16 (at Week 32))
- Percentage of Participants With Global Aesthetic Improvement Based on the Subject's Global Aesthetic Improvement Scale on Décolleté Wrinkles (sGAIS-Wrinkles) as Assessed by the Participant (LOCF)(16 weeks after the last treatment on Week 16 (at Week 32))
研究者
研究点 (18)
Loading locations...
相似试验
已完成
不适用
The Use of J-Plasma® for Dermal ResurfacingFacial WrinklesRhytidesNCT03286283Apyx Medical55
已完成
2 期
Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown LinesGlabellar Frown LinesNCT02236312Galderma R&D359
已完成
不适用
A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot UlcersNeuropathic Diabetic Ulcer - FootNCT01060670Integra LifeSciences Corporation545
已完成
不适用
Safety and Efficacy of XP200 Radiofrequency Treatment of WrinklesPeriorbital WrinklesNCT01795417BTL Industries Ltd.50
Unknown
不适用
Evaluation of Safety and Efficacy of TriPollar Device for Treatment of WrinklesFacial WrinklesNCT01858415Pollogen40