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NCT Number: NCT07680426

A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery

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.

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Key information

Conditions

Photodamaged Skin Skin Cancer Prevention Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ablative fractional laser

Device

Treatment with AFL on the dorsal part of hand

Other names: AFL, CO2 Laser

Poly-L-lactic acid

Device

Following AFL, PLLA will be applied to the same area

Other names: Sculptra, PLLA

Primary outcomes

  1. 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

  1. Transcriptomic response

    Time frame: 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.

  2. Safety of interventions

    Time frame: 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.

  3. Pain assessment

    Time frame: 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.

  4. Patient-reported improvement

    Time frame: 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.

  5. Patient satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Through AI-Assisted In Vivo Imaging and Transcriptomics

Acronym: SYNTROMICS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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