An interventional study of Ablative fractional laser and Poly-L-Lactic Acid in Photodamaged Skin and Skin Cancer Prevention, sponsored by Bispebjerg Hospital. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Prevention
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.
496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.
This study's planned enrollment of 33 is below the median of 70 across 375 interventional studies indexed under Skin Diseases.
Browse Skin Diseases studies →Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AFL treatment followed by immediate topical application of PLLA
Device: Ablative fractional laser · Device: Poly-L-Lactic Acid
Treatment with AFL alone
Device: Ablative fractional laser
No treatment
Treatment with AFL on the dorsal part of hand
Also known as: AFL, CO2 Laser
Following AFL, PLLA will be applied to the same area
Also known as: Sculptra, PLLA
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 36
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 36
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 36
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 36
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 36
Patient satisfaction
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.
Time frame: Baseline to Week 36
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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