Photodamaged Skin, Skin Cancer Prevention
Conditions
Keywords
laser-assisted drug delivery, optical coherence tomography, poly-l-lactic acid, transcriptomics, ablative fractional laser, Photodamaged skin, skin cancer prevention, sculptra, skin diseases, non-invasive imaging
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.
Interventions
Treatment with AFL on the dorsal part of hand
DEVICEPoly-L-Lactic Acid
Following AFL, PLLA will be applied to the same area
Sponsors
Bispebjerg Hospital
Study design
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.
Intervention model description
This study is designed as a prospective, randomized, within-subject, translational exploratory study. Participants will receive treatment on the dorsal sides of both hands. Within each participant, one hand will be randomly assigned to treatment with AFL alone, while the contralateral hand will be assigned to treatment with AFL followed by immediate topical application of PLLA. Each hand will also include an untreated control site, allowing for intra-individual comparisons of treatment effects.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy | 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
| Measure | Time frame | Description |
|---|---|---|
| Transcriptomic response | Baseline to Week 36 | 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. |
| Safety of interventions | Baseline to week 36 | 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. |
| Pain assessment | Baseline to Week 36 | 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. |
| Patient-reported improvement | From baseline to Week 36 | 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. |
| Patient satisfaction | Baseline to Week 36 | 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. |
Countries
Denmark
Outcome results
None listed