An interventional study of 1927-nm thulium laser and 1550-nm Er:Glass laser in Photo-damage and Actinic Keratosis (AK), sponsored by Merete Haedersdal. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Merete Haedersdal · Not applicable, Interventional, and Prevention
The Multimodal Laser Project is a prospective, randomized, split-face clinical study investigating a novel combination of laser and light-based treatments for facial photodamage with the long-term perspective of improving skin cancer prevention.
The study includes 35 patients with facial photodamage and AKs. One side of the face receives a multimodal treatment combining three complementary technologies: 1927-nm thulium laser, 1550-nm non-ablative fractional laser, and intense pulsed light (IPL), while the contralateral side serves as an untreated control.
Participants are followed for 14 months to assess both clinical efficacy and longer-term preventive effects.
The overall aim is not only to determine whether multimodal laser treatment improves photodamaged skin, but also to gain a deeper understanding of how the treatment affects the underlying biology of chronically sun-damaged skin and its potential role in skin cancer prevention.
343 studies on the registry are indexed under Keratosis, Actinic; 29 are open to participants now.
This study's planned enrollment of 35 is below the median of 60 across 295 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Merete Haedersdal is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Multimodal treatment with 1927-nm thulium laser + 1550-nm non-ablative fractional laser (NAFL) + intense pulsed light (IPL)
Device: 1927-nm thulium laser · Device: 1550-nm Er:Glass laser · Device: Intense Pulsed Light
No treatment
Fractional non-ablative 1927-nm thulium laser treatment applied to the randomized intervention side of the face
Also known as: fractional laser
Fractional non-ablative 1550-nm Er:Glass laser treatment applied to the randomized intervention side of the face
Also known as: non-ablative fractional laser
Intense pulsed light treatment applied to the randomized intervention side of the face
Also known as: IPL
Clinical improvement
Change from baseline in the overall clinical appearance of facial photodamage will be assessed using a 5-point Global Aesthetic Improvement Scale (GAIS) based on standardized clinical photographs and on-site evaluation. Assessments will be performed by the site investigator and independent blinded physicians. The scale ranges from 1 to 5, where 1 = very much improved and 5 = worse. Lower scores indicate greater clinical improvement.
Time frame: Baseline to Week 60
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 60
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 60
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 60
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 60
Change in Actinic Keratosis Count
Change from baseline in the total number of clinically identified actinic keratoses within the study area.
Time frame: Baseline to Week 60
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merete Haedersdal