A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBispebjerg Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ablative fractional laser
DeviceTreatment with AFL on the dorsal part of hand
Poly-L-Lactic Acid
DeviceFollowing AFL, PLLA will be applied to the same area
Treatment groups
33 Participants
are divided into 3 treatment groupsGroup A: Laser-assisted PLLA deliveryExperimental treatment 2 interventions
Group B: AFL treatmentActive comparator 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Clinical efficacy
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.
Time frame
Baseline to Week 36Secondary outcomes
1
Transcriptomic response
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.
Time frame
Baseline to Week 362
Safety of interventions
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.
Time frame
Baseline to week 363
Pain assessment
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.
Time frame
Baseline to Week 364
Patient-reported improvement
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.
Time frame
From baseline to Week 36Sponsors and contacts
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Source ClinicalTrials.gov
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