Photo-damage, Actinic Keratosis (AK)
Conditions
Keywords
laser, photodamaged skin, IPL, non-ablative fractional laser, fractional laser, Thulium laser, UV damage
Brief summary
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.
Interventions
DEVICE1927-nm thulium laser
Fractional non-ablative 1927-nm thulium laser treatment applied to the randomized intervention side of the face
DEVICE1550-nm Er:Glass laser
Fractional non-ablative 1550-nm Er:Glass laser treatment applied to the randomized intervention side of the face
DEVICEIntense Pulsed Light
Intense pulsed light treatment applied to the randomized intervention side of the face
Sponsors
Merete Haedersdal
CynosureLutronic
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded assessors will be reviewing and scoring the clinical photos after the study is completed.
Intervention model description
This study is designed as a prospective, randomized, split-face, within-subject exploratory study. Participants with facial photodamage will receive multimodal laser treatment on one randomly assigned side of the face, while the contralateral side will remain untreated and serve as an intra-individual control. The multimodal treatment combines three complementary laser and light-based modalities: 1927-nm thulium laser, 1550-nm non-ablative fractional laser, and intense pulsed light (IPL). This design allows for direct intra-individual comparison of treatment effects.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Contraindications to the three lasers or topical anesthetics * 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 * Contraindications to the three lasers or topical anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | Baseline to Week 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transcriptomic response | Baseline to Week 60 | 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. |
| Safety of interventions | Baseline to Week 60 | 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. |
| Pain assessment | Baseline to Week 60 | 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. |
| Patient satisfaction | Baseline to Week 60 | 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. |
| Change in Actinic Keratosis Count | Baseline to Week 60 | Change from baseline in the total number of clinically identified actinic keratoses within the study area. |
Countries
Denmark
Contacts
CONTACTAqella Rasul, MD
Outcome results
None listed