New HA Filler Versus Juvederm for Nasolabial Fold Correction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- WSRS
研究概览
简要总结
The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction
详细描述
A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of new HA filler versus Juvederm for nasolabial fold correction
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides
排除标准
- •patients with active facial skin diseases or history of severe allergies, autoimmune disorders, or hypersensitivity to HA or any of the excipients contained in the investigational filler
- •participants who had used a local topical preparation (steroid and retinoid) within 2 weeks before the study
- •participants who had undergone chemical peeling, laser procedures, or acne treatments within 4 months before the study
- •participants who had been injected with other biomaterials, including HA within 6 months before the study.
研究组 & 干预措施
New HA filler (Curea)
The left/right assignment was sealed in a nontransparent envelop.
干预措施: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea) (Drug)
Juvederm
The left/right assignment was sealed in a nontransparent envelop.
干预措施: JuvedermⓇ (Q-Med AB, Uppsala, Sweden) (Drug)
结局指标
主要结局
WSRS
时间窗: at 24 weeks after treatment
Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds)
次要结局
- GAIS(at 24 weeks after treatment)
- Adverse events related to the procedure(up to 24 weeks)
研究者
Bo Ri Kim
Assistant professor
Seoul National University Bundang Hospital