Photodamaged SkinSYNTROMICSNCT07680426
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery
A study testing Ablative fractional laser and Poly-L-Lactic Acid in people with Photodamaged Skin and Skin Cancer Prevention, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photodamaged Skin, Skin Cancer Prevention
- What is being tested?
- Ablative fractional laser and Poly-L-Lactic Acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Bispebjerg Hospital
Copenhagen, Capital Region, 2400
Aqella Rasul, MD, 004571590063, aqella.rasul.01@regionh.dk
About this study
Official title: A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Through AI-Assisted In Vivo Imaging and Transcriptomics
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.
- Conditions
- Photodamaged Skin, Skin Cancer Prevention
- Being tested
- Ablative fractional laser, Poly-L-Lactic Acid
- 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
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative fractional laserDevice
Also called AFL, CO2 Laser
Treatment with AFL on the dorsal part of hand
Poly-L-Lactic AcidDevice
Also called Sculptra, PLLA
Following AFL, PLLA will be applied to the same area
| Study group | Role | What they receive |
|---|---|---|
| Laser-assisted PLLA delivery | Experimental | AFL treatment followed by immediate topical application of PLLA Receives: Device: Ablative fractional laser; Device: Poly-L-Lactic Acid |
| AFL treatment | Active comparator | Treatment with AFL alone Receives: Device: Ablative fractional laser |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 36
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merete Haedersdal, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680426
- Sponsor's protocol ID
- 16-0302-103
- Other IDs
- 16-0302-103
- Acronym
- SYNTROMICS
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Through AI-Assisted In Vivo Imaging and Transcriptomics
- ClinicalTrials.gov ID
- NCT07680426
- Acronym / sponsor ID
- SYNTROMICS / 16-0302-103
- Conditions
- Photodamaged Skin, Skin Cancer Prevention
- Keywords
- laser-assisted drug delivery, optical coherence tomography, poly-l-lactic acid, transcriptomics, ablative fractional laser, Photodamaged skin, skin cancer prevention, sculptra
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser-assisted PLLA delivery | Experimental | Device: Ablative fractional laser, Device: Poly-L-Lactic AcidAFL treatment followed by immediate topical application of PLLA |
| AFL treatment | Active comparator | Device: Ablative fractional laserTreatment with AFL alone |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablative fractional laserAlso: AFL, CO2 LaserTreatment with AFL on the dorsal part of hand | Device | AFL treatment, Laser-assisted PLLA delivery |
| Poly-L-Lactic AcidAlso: Sculptra, PLLAFollowing AFL, PLLA will be applied to the same area | Device | Laser-assisted PLLA delivery |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Photodamaged Skin
Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
Not yet recruitingPhase 2/3
Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
Photodamaged Skin
Recruiting
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Photodamaged Skin, Rhytids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablative fractional laser and Poly-L-Lactic Acid in people with Photodamaged Skin and Skin Cancer Prevention, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy (time frame: Baseline to Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.