A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Overnight Occlusive Topical 10% 35 kDa Hyaluronan (HA35) Gel for Facial Subcutaneous Fat Appearance, Erythema, Skin Radiance, and Pore Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
研究概览
简要总结
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of overnight occlusive topical application of 10% high-concentration 35 kDa hyaluronan (HA35) gel for facial aesthetic improvement. Eligible participants will receive overnight occlusive application once every 2 days for a total of 5 treatments over 10 days. The primary objectives are to assess changes in facial subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore enlargement after 1 and 5 applications. Safety and local tolerability will be evaluated throughout the study period. This is a minimal-risk, non-pharmacological, non-invasive aesthetic intervention.
详细描述
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of overnight occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving multiple facial aesthetic outcomes, including subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore condition.
Eligible subjects will apply HA35 gel to the entire face before sleep, covered with an occlusive film to retain moisture, and left in place overnight. The intervention will be administered once every 2 days for 5 applications over 10 days.
Outcomes will be assessed at baseline, after 1 application, and after 5 applications using a standardized 0-10 Numeric Rating Scale (NRS) for subcutaneous fat thickness, erythema severity, skin radiance, and pore enlargement. Local skin tolerability and adverse events will be monitored throughout the study.
This is a non-invasive, non-pharmacological aesthetic intervention with minimal risk. All procedures are conducted in accordance with the Declaration of Helsinki, and written informed consent is obtained from all subjects prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years, male or female
- •Seeking non-invasive improvement of facial appearance
- •Presenting with at least one of: facial subcutaneous fat accumulation, facial erythema, skin dullness, nasal alar pore enlargement
- •Baseline NRS score ≥2 for at least one target parameter
- •Ability to complete self-assessments
- •Signed written informed consent
排除标准
- •Facial aesthetic treatments (injection, laser, fat reduction, peeling) within 2 weeks
- •Active facial dermatitis, infection, or open wounds
- •Known hypersensitivity to hyaluronan or gel components
- •Pregnant or lactating women
- •Severe systemic disease or uncontrolled medical condition
研究组 & 干预措施
HA35 Overnight Occlusive Topical Gel Group
Participants receive 10% high-concentration 35 kDa HA35 gel as overnight occlusive topical application to the entire face, once every 2 days for 5 applications over 10 days. Efficacy on facial fat, erythema, radiance, pores, and safety will be evaluated.
干预措施: 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel (Device)
结局指标
主要结局
Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
时间窗: Baseline to after 1 application and after 5 applications
Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness.
次要结局
- Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)(Baseline (Day 0) to Day 2 and Day 10)
- Change in Facial Skin Radiance (0-10 NRS Score)(Baseline (Day 0) to Day 2 and Day 10)
- Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)(Baseline (Day 0) to Day 2 and Day 10)
- Incidence and Severity of Local Skin Adverse Events(Baseline (Day 0) to Day 2 and Day 10)
- Incidence and Severity of Local Skin Adverse Events(From Day 0 to Day 10)