A Randomized, Single-center, Prospective Biopsy Study Comparing a Poly L-lactic Acid Biostimulator and a Calcium Hydroxylapatite Semi-permanent Filler
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Analyze gene expression via punch biopsy
研究概览
简要总结
To compare gene expression stimulated by a semi-permanent filler and a biostimulator via punch biopsy
详细描述
This is a randomized, single-center, comparative study to evaluate gene expression after treatment with a semi-permanent filler or a biostimulator.
This study is designed to enroll and randomize approximately 20 subjects in a 1:1 ratio of treatment to PLLA or CaHA. All randomized subjects are to have contour deficiency at the nasolabial folds.
Eligible subjects randomized to receive punch biopsy followed by treatment injection by the Treating Investigator at baseline. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the nasolabial folds, in the opinion of the Treating Investigator. PLLA group receives a second treatment at week 4 while CaHA group receives an optional touch-up if needed.
All subjects have final follow-up visit for a second punch biopsy on the other side of the nasolabial fold.
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 (Participant)
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with a minimum of shallow nasolabial fold (NLF) contour deficiencies as assessed via the wrinkle assessment scale
- •Subject with identical WAS scores on both NLFs
- •Ability of giving consent for participation in the study
- •Agreement to have skin biopsies on NLFs
排除标准
- •Significant NLF asymmetry, or different WAS score on each NLF
- •Pregnant, planning pregnancy during the course of the study or breastfeeding
- •History of allergy or hypersensitivity to any ingredient of the treatment products
- •History of allergy or hypersensitivity to anesthetics or lidocaine
研究组 & 干预措施
Poly L-Lactic Acid (PLLA)
Lyophilized PLLA with sodium carboxymethylcellulose, non-pyrogenic mannitol. Treatment needs to be reconstituted prior to injection, following product instruction.
干预措施: Sculptra (Device)
Calcium Hydroxylapatite (CaHA)
Opaque, sterile, non-pyrogenic, semi-solid, cohesive implant whose component is synthetic CaHA suspended in a gel carrier of glycerin, sodium carboxymethylcellulose, 0.3% lidocaine hydrochloride, and sterile water. Treatment injection follows product instruction.
干预措施: Radiesse Plus (Device)
结局指标
主要结局
Analyze gene expression via punch biopsy
时间窗: 12 weeks after baseline
Summary of fold change using by relative quantification method at week 12. Gene expression analysis is performed via qPCR processing using a panel of biomarkers related to scar tissue formation, collagen, elastin, extracellular matrix integrity, epidermal barrier, anti-aging, antioxidant, cell renewal/regeneration, inflammation, growth factor, and hydration among others.
Gene Expression
时间窗: 12 weeks after baseline
Summary of fold change using by relative quantification method at week 12. Gene expression analysis is performed via qPCR processing using a panel of biomarkers related to scar tissue formation, collagen, elastin, extracellular matrix integrity, epidermal barrier, anti-aging, antioxidant, cell renewal/regeneration, inflammation, growth factor, and hydration among others.
次要结局
- Evaluate volume change in the treated area using 3D imaging(4 and 12 weeks after baseline)