A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ablative fractional laser, Poly-L-Lactic Acid.
- Who it may be relevant to
- Registry conditions: Photodamaged Skin, Skin Cancer Prevention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Through AI-Assisted In Vivo Imaging and Transcriptomics
Overview
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.
Interventions
- Device Ablative fractional laser
Treatment with AFL on the dorsal part of hand - Device Poly-L-Lactic Acid
Following AFL, PLLA will be applied to the same area
Primary outcome measures
- Clinical efficacy [Time frame: Baseline to Week 36]
Secondary outcome measures (5)
- Transcriptomic response [Time frame: Baseline to Week 36]
- Safety of interventions [Time frame: Baseline to week 36]
- Pain assessment [Time frame: Baseline to Week 36]
- Patient-reported improvement [Time frame: From baseline to Week 36]
- Patient satisfaction [Time frame: Baseline to Week 36]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Bispebjerg Hospital — Copenhagen
Identifiers
NCT: NCT07680426 · 16-0302-103 · 16-0302-103