Multimodal Laser Treatment of Photodamaged Skin

Merete Haedersdal35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Photo-damage Actinic Keratosis (AK)

Interventions

1927-nm thulium laserDEVICE

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

1550-nm Er:Glass laserDEVICE

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

Intense Pulsed LightDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.