A Multi-center, Post-market Cosmetic Evaluation of Ariessence™ Pure PDGF+ Following Ablative Laser for the Tolerability and Improvement in the Appearance of Aging Skin.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Clinical Measures
研究概览
简要总结
ariessence is intended to be used as a viscous, leave-on solution designed for topical application to the face. It is intended to be used following non-medical cosmetic procedures, performed by licensed healthcare professionals to enhance comfort and maintain skin hydration. This study is designed to be a multi-center, post-market cosmetic evaluation of ariessence applied to the full face after an ablative laser procedure to evaluate improvements in procedure tolerability and improvements in the appearance of the skin, compared to an emollient control.
详细描述
To compare procedure tolerability of the treated facial area between ariessence and standard aftercare (Aquaphor). Tolerability, using subject tolerability assessments (subject diaries), investigator tolerability assessments, and standardized day-3/7/14 photographs, with site confirmation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •:Adults 40-65 70 years
- •Glogau III-IV
- •Fitzpatrick II-IV.
- •Suitable for ablative laser
- •non-smoker ≥ 3 years
- •Willing to comply with post-procedure regimen
- •patient reported outcome documentation, and photo documentation.
排除标准
- •Fitzpatrick I or > IV,
- •recent facial procedures (< 6 months)
- •active skin disease
- •pregnancy/lactation
- •implanted devices
- •history of keloids.
结局指标
主要结局
Clinical Measures
时间窗: Baseline (Day 0) through Day 84 (End of Study).
Glogau Scale
Patient-Reported Outcomes
时间窗: Baseline through day 84
FACE-Q, SKIN-Q, FACE-Q Psychological Function, treatment Discomfort/Pain Evaluation Subject Satisfaction Scale
Photography
时间窗: Baseline through Day 84
VISIA-CR (standardized frontal ±45°), FitSkin (regional close-ups), and point-and-shoot baseline and follow-ups
Investigator Objective Tolerability Assessment
时间窗: Baseline through Day 84
Tolerability of product
Erythema grading (0-4 scale)
时间窗: Baseline through Day 84 (End of Study)
Degree of erthema
Clinician's Global Aesthetic Improvement Scale (CGAIS).
时间窗: Baseline through Day 84 (End of STudy)
Measure of Aestetic Imporvement
次要结局
未报告次要终点