A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery (SYNTROMICS)
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Through AI-Assisted In Vivo Imaging and Transcriptomics
Photodamaged skin increases the risk of skin cancer, highlighting the need for preventive treatments. Laser-assisted drug delivery (LADD) using ablative fractional lasers (AFL) enhances topical drug delivery and has proven safe and effective. Integrating non-invasive optical imaging techniques with transcriptomic gene expression profiling enables evaluation of the response of different skin layers to such interventions.
It is hypothesized that AFL-assisted delivery of biostimulators exerts synergistic regenerative effects on photodamaged skin, resulting in superior clinical, molecular, and morphological improvements, as well as enhanced epidermal and dermal remodeling, compared with either monotherapy alone. The study aims to provide an in-depth understanding of the individual and combined effects of AFL and biostimulators on the regeneration of photodamaged skin through clinical assessments, non-invasive imaging, and transcriptomic analysis.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Capital Region
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Copenhagen、Capital Region、丹麦、2400
- Bispebjerg Hospital
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接触：
- Aqella Rasul, MD
- 电话号码：004571590063
- 邮箱：aqella.rasul.01@regionh.dk
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age ≥18 years
- Clinical signs of photodamage. Signs will include low-grade actinic keratoses (Olsen grade I-II), solar lentigines, telangiectasia, or other visible markers of chronic photodamage.
Exclusion Criteria:
- Active skin diseases in the treatment site
- Laser treatment, PLLA, or other treatments in the treatment area within the past 24 months
- Pregnancy or breastfeeding
- Contraindications to AFL or Sculptra
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制
没有治疗
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实验性的：Laser-assisted PLLA delivery
AFL treatment followed by immediate topical application of PLLA
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Treatment with AFL on the dorsal part of hand
其他名称：
Following AFL, PLLA will be applied to the same area
其他名称：
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有源比较器：AFL treatment
Treatment with AFL alone
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Treatment with AFL on the dorsal part of hand
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical efficacy
大体时间：Baseline to Week 36
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Change from baseline in the overall clinical appearance of photodamage in the treated area will be assessed using a 5-point Global Improvement Score (GIS) ranging from 0 to 4, where 0 indicates no improvement and 4 indicates >75 % improvement.
Assessments will be performed by the on-site investigator and independent blinded physicians based on standardized clinical photographs.
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Baseline to Week 36
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Transcriptomic response
大体时间：Baseline to Week 36
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Changes in gene expression profiles will be assessed by transcriptomic analysis of tape-strip samples collected before and after treatment and compared between intervention arms.
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Baseline to Week 36
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Safety of interventions
大体时间：Baseline to week 36
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Safety will be evaluated by the incidence, severity, and relationship to treatment of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period. AEs and SAEs will be recorded continuously at each study visit and assessed by the investigator. |
Baseline to week 36
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Pain assessment
大体时间：Baseline to Week 36
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Pain associated with each intervention will be assessed using a patient-reported Numeric Rating Scale (NRS) ranging from 1 to 10, where 1 indicates minimal pain and 10 indicates the worst imaginable pain.
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Baseline to Week 36
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Patient-reported improvement
大体时间：From baseline to Week 36
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Perceived improvement will be assessed using a 5-point improvement scale ranging from 0 to 4, where 0 indicates no improvement and 4 indicates the greatest possible improvement.
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From baseline to Week 36
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Patient satisfaction
大体时间：Baseline to Week 36
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Patient satisfaction will be assessed using a 5-point satisfaction scale ranging from -2 to +2, where -2 indicates very dissatisfied, 0 indicates neutral, and +2 indicates very satisfied.
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Baseline to Week 36
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 16-0302-103 (其他标识符：De Videnskabsetiske Medicinske Komitéer)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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