Split-face Study of Changing in Skin Physiology and Clinical Appearance After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Erythema Index
研究概览
简要总结
IMPORTANCE Skin rejuvenation can be achieved effectively and safely by injection of a stabilized hyaluronic acid (HA)-based gel of nonanimal origin (NASHA) injection using a stamp-type electronic multineedle injector.
OBJECTIVE To determine the efficacy and safety of NASHA using a stamp-type electronic multineedle injector, and if changes in skin physiology occur earlier than in previous trials.
DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.One dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). The subjects and two independent investigators assessed the clinical improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit. Twenty-four participants completed the study, and no participants withdrew due to adverse effects.
INTERVENTIONS Each participant submitted to a single treatment with a NASHA injection to one side of the lower cheek. The cheek side to which the treatment was applied was chosen randomly.
详细描述
Twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial. Twenty-four participants completed the study, and no participants withdrew due to adverse effects. Each participant submitted to a single treatment with a NASHA injection to one side of the lower cheek. One dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). The subjects and two independent investigators assessed the clinical improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit. Adverse events were self-reported by the patients completing a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people older than 25 years
排除标准
- •known hypersensitivity to HA, an active skin disease, any autoimmune disorder, or significant renal, hepatic, or other medical diseases
结局指标
主要结局
Erythema Index
时间窗: 12 weeks
We measured an erythema index by a mexameter device (Courage \& Khazaka, Cologne, Germany). The range of erythema index is 0\~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) \~999 AU (most erythematous possible)
Elasticity
时间窗: 12 weeks
We measured a elasticity by a reviscometer device (Courage \& Khazaka, Cologne, Germany). The range of elasticity was 0 (most elastic possible as) \~400 AU(Arbitrary Unit) (inelastic as possible)
Global Aesthetic Improvement Scale (Investigator)
时间窗: 12 weeks
The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse.
Global Aesthetic Improvement Scale (Subject)
时间窗: 12 weeks
The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse
Hydration Level
时间窗: 12 weeks
We measured a hydration level by a corneometer device (Courage \& Khazaka, Cologne, Germany). The range of hydration level was 0 (as dry as possible) \~120 AU (Arbitrary Unit)(most moist possible)
Melanin Index
时间窗: 12 weeks
We measured a melanin index by a mexameter device (Courage \& Khazaka, Cologne, Germany). The range of melanin index was 0 (as bright as possible) \~999 AU (Arbitrary Unit) (most dark possible).
次要结局
未报告次要终点
研究者
Yang Won Lee
Professor
Konkuk University Hospital