The Efficienctiveness of Poly-L-Lactic Acid, PLLA for the Treatment of Skin Laxity of the Neck: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Neck Skin Laxity Scale (NSL scale) Score
研究概览
简要总结
Skin aging of the neck commonly leads to wrinkles and skin laxity due to the gradual loss of collagen and structural support in the skin. Although several treatments are available, effective non-surgical options for improving neck skin laxity remain limited. This pilot study aims to evaluate the effectiveness and safety of Poly-L-Lactic acid (PLLA) injections for improving neck skin laxity.
详细描述
This study is a prospective pilot interventional study designed to evaluate the effectiveness and safety of Poly-L-Lactic acid (PLLA) injections for the treatment of neck skin laxity. Eligible Thai male and female participants aged 30 to 60 years with neck skin laxity grades 1 to 4 according to the Neck Skin Laxity Scale (NSL scale) will be enrolled. Participants will receive a single treatment session of PLLA injection to the neck using a cannula technique in the subcutaneous plane with a linear retrograde fanning method through lateral entry points. Approximately 8 mL of PLLA solution will be injected on each side of the neck, for a total volume of 16 mL per participant. Clinical outcomes will be evaluated at baseline and during follow-up visits at weeks 8, 16, and 24. Outcome measures include improvement in neck skin laxity assessed using the NSL scale, changes in skin elasticity measured by using the Cutometer® Dual MPA 580, participant satisfaction, and treatment-related adverse events. Outcome assessment will be performed by comparing follow-up measurements with baseline values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Thai male or female participants aged 30-60 years
- •Individuals who wish to improve neck skin laxity
- •Presence of neck skin laxity grade 1-4 according to the Neck Skin Laxity Scale (NSL scale)
排除标准
- •Pregnant or breastfeeding women
- •History of allergy or hypersensitivity to local anesthetics or components of collagen-stimulating substances
- •Active autoimmune disease requiring systemic treatment
- •History of cosmetic procedures in the neck area, including laser treatment, radiofrequency, or ultrasound-based devices within 6 months prior to treatment
- •History of dermal filler injection in the neck area
- •History of botulinum toxin injection in the neck area within 6 months prior to treatment
结局指标
主要结局
Change in Neck Skin Laxity Scale (NSL scale) Score
时间窗: Baseline (Week 0), Week 8, Week 16, and Week 24
Neck skin laxity will be evaluated using standardized clinical photographs captured with the VECTRA® image system. Blinded dermatologists will assess neck skin laxity using NSL Scale at baseline (Week0), Week 8, Week 16, and Week 24. The NSL Scale is a 5-point ordinal scale ranging from 0 to 4, where : 0 = Absent : No visible neck skin laxity. 1. = Mild : Minimal skin laxity with slight loss of firmness and subtle horizontal lines. 2. = Moderate : Noticeable skin laxity with visible horizontal lines and mild skin redundancy. 3. = Advanced : Marked skin laxity with prominent folds, visible skin redundancy, and moderate loss of neck contour. 4. = Severe : Severe skin laxity characterized by extensive redundant skin, deep folds, wrinkles, and substantial loss of neck contour. Higher scores indicate greater neck skin laxity and a worse aesthetic appearance, while lower scores indicate less neck skin laxity and improvement in neck appearance.
次要结局
- Participant-Reported Neck Appearance Satisfaction Score Assessed Using the 5-Point Neck Appearance Satisfaction Scale(Baseline (Week 0), Week 8, Week 16, and Week 24)
- Change in skin Firmness and Elasticity Assessed by Cutometer® Dual MPA 580(Baseline (Week 0), Week 8, Week 16, and Week 24)
- Incidence of Treatment-Related Adverse Events(Immediately after PLLA injection (Week 0), Week 8, Week 16, and Week 24)