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Multimodal Laser Treatment of Photodamaged Skin

ConditionsPhoto-damageActinic Keratosis (AK)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerete Haedersdal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Clinical signs of facial photodamage, including low-grade actinic keratosis (Olsen grade I-II) , solar lentigines, mottled hyper- and hypopigmentation, telangiectasia, skin thinning or atrophy, loss of skin elasticity (solar elastosis), coarse, leathery texture

Disqualifiers

Fitzpatrick skin type ≥ 4

Active skin disease in the treatment area that may interfere with study treatment or assessments

Cosmetic treatments in the face within the last 12 months, including but not limited to chemical peels, injectables, and light- or laser-based treatments

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • 1927-nm thulium laser

    Device

    Fractional non-ablative 1927-nm thulium laser treatment applied to the randomized intervention side of the face

  • 1550-nm Er:Glass laser

    Device

    Fractional non-ablative 1550-nm Er:Glass laser treatment applied to the randomized intervention side of the face

  • Intense Pulsed Light

    Device

    Intense pulsed light treatment applied to the randomized intervention side of the face

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Multimodal treatmentExperimental treatment 3 interventions
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary 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 60
2

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
3

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
4

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Department of Dermatology, Bispebjerg HospitalRecruiting2400, Copenhagen NVDenmarkDenmark

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merete Haedersdal

Lead sponsor

Bispebjerg Hospital

Sponsor institution

CynosureLutronic

Collaborator

University of Copenhagen

Collaborator

Source ClinicalTrials.gov
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