Treatment of Periocular Wrinkles With the Active Ingredients PDRN, Hyaluronic Acid and Niacinamide, Applied by Needling or Microneedling: Randomized Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- severity of periocular wrinkles
研究概览
简要总结
This randomized clinical trial aims to compare two application techniques-needling (intradermal needling) and microneedling-for the delivery of an active-ingredient formulation containing 0.2% polynucleotides (PDRN), 2% hyaluronic acid, and 0.1% niacinamide for the treatment of periocular wrinkles related to aging.
详细描述
Facial aging in the periocular region results from cumulative sun exposure, reduced dermal thickness, and repetitive muscular contraction, contributing to wrinkle formation and loss of skin quality. Polynucleotides (PDRN) have been reported as cellular-regeneration agents with potential to improve skin texture, hydration, and tissue recovery. The present study evaluates the clinical efficacy of a formulation composed of 0.2% PDRN, 2% hyaluronic acid, and 0.1% niacinamide, delivered by two minimally invasive techniques: needling (intradermal needling) and microneedling.
Twenty four participants will be randomly allocated (1:1) into two treatment arms: needling (n=12) or microneedling (n=12). Each participant will receive three treatment sessions spaced 30 days apart, with a total volume of 1 mL applied per session. Standardized 3D facial imaging (Vectra system) will be used to assess periocular wrinkle severity (0-100%), Glogau's photoaging scale (scores 1 - 4), epigenetic markers along with skin-quality parameters, pigmentation, and inflammatory response at baseline and at 30 and 180 days following the first session. Intra-group and inter-group comparisons will be conducted using a significance level of 5%.
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)
盲法说明
statistics
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Glogau II and III
- •Fitzpatrick II and III
排除标准
- •Pregnancy
- •immune diseases
- •aesthetics facial treatment in the past 6 months
研究组 & 干预措施
Intradermotherapy
polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by intradermal injection
干预措施: Intradermal injection (Procedure)
Microneedling
polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by micro needling
干预措施: Micro needling (Procedure)
结局指标
主要结局
severity of periocular wrinkles
时间窗: baseline vs. 30 days
changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs
次要结局
- Glogau's facial photoaging scale(Baseline vs. 6 months)
- LINE-1(baseline vs. 6 months)
- severity of periocular wrinkles(Baseline vs. 6 months)
- LINE-1(baseline vs. 30 days)
研究者
Jose Roberto Cortelli
Titular Professor
University of Taubate
