A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Through AI-Assisted In Vivo Imaging and Transcriptomics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Clinical efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded assessors will be reviewing and scoring the clinical photos after the study is completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Laser-assisted PLLA delivery
AFL treatment followed by immediate topical application of PLLA
干预措施: Poly-L-Lactic Acid (Device)
结局指标
主要结局
Clinical efficacy
时间窗: Baseline to Week 36
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.
次要结局
- Transcriptomic response(Baseline to Week 36)
- Safety of interventions(Baseline to week 36)
- Pain assessment(Baseline to Week 36)
- Patient-reported improvement(From baseline to Week 36)
- Patient satisfaction(Baseline to Week 36)
研究者
Merete Haedersdal
Professor, MD, PhD, DMSc
Bispebjerg Hospital