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临床试验/NCT07280637
NCT07280637进行中(未招募)不适用

Treatment of Periocular Wrinkles With the Active Ingredients PDRN, Hyaluronic Acid and Niacinamide, Applied by Needling or Microneedling: Randomized Clinical Trial"

University of Taubate2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年11月30日最近更新:
干预措施

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

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

Experimental

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

Active Comparator

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

发起方
University of Taubate
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Roberto Cortelli

Titular Professor

University of Taubate

研究点 (2)

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