Multimodal Laser Treatment of Photodamaged Skin

NCT07789002 — Not applicable, Recruiting, 35 participants, Merete Haedersdal

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Registry	NCT07789002
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	35 (Estimated)
Sponsor	Merete Haedersdal (Other); collaborators: CynosureLutronic, University of Copenhagen
Conditions	Photo-damage, Actinic Keratosis (AK)
Interventions	1927-nm thulium laser, 1550-nm Er:Glass laser, Intense Pulsed Light (Device)
Dates	start 2026-09-01 (estimated), primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2026-08-27, last updated 2026-09-09
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Multimodal treatment	Experimental	Device: 1927-nm thulium laser; Device: 1550-nm Er:Glass laser; Device: Intense Pulsed Light	Multimodal treatment with 1927-nm thulium laser + 1550-nm non-ablative fractional laser (NAFL) + intense pulsed light (IPL)
Control	No intervention		No treatment

1927-nm thulium laser (Device), also known as fractional laser: Fractional non-ablative 1927-nm thulium laser treatment applied to the randomized intervention side of the face
1550-nm Er:Glass laser (Device), also known as non-ablative fractional laser: Fractional non-ablative 1550-nm Er:Glass laser treatment applied to the randomized intervention side of the face
Intense Pulsed Light (Device), also known as IPL: Intense pulsed light treatment applied to the randomized intervention side of the face

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Department of Dermatology, Bispebjerg Hospital	Copenhagen NV	Denmark	Recruiting