A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Through AI-Assisted In Vivo Imaging and Transcriptomics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Clinical efficacy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Blinded assessors will be reviewing and scoring the clinical photos after the study is completed.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Laser-assisted PLLA delivery
AFL treatment followed by immediate topical application of PLLA
Intervention: Poly-L-Lactic Acid (Device)
Outcomes
Primary Outcomes
Clinical efficacy
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Merete Haedersdal
Professor, MD, PhD, DMSc
Bispebjerg Hospital