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NCT Number: NCT07789002

Multimodal Laser Treatment of Photodamaged Skin

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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Key information

Conditions

Photo-damage Actinic Keratosis (AK) Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location status: Recruiting

Location contact

Aqella Rasul, MD

CONTACT

[email protected]

0045 71590063

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1927-nm thulium laser

Device

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

Other names: fractional laser

1550-nm Er:Glass laser

Device

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

Other names: non-ablative fractional laser

Intense Pulsed Light

Device

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

Other names: IPL

Primary outcomes

  1. Clinical improvement

    Time frame: 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

  1. Transcriptomic response

    Time frame: 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.

  2. Safety of interventions

    Time frame: 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.

  3. Pain assessment

    Time frame: 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.

  4. Patient satisfaction

    Time frame: 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.

  5. Change in Actinic Keratosis Count

    Time frame: Baseline to Week 60

    Change from baseline in the total number of clinically identified actinic keratoses within the study area.

Study contacts

Contact information is provided by the study sponsor or research team.

Aqella Rasul, MD

CONTACT

[email protected]

0045 71590063

Sponsors and collaborators

Lead sponsor

Merete Haedersdal

Other

Collaborators

  • CynosureLutronic
  • University of Copenhagen

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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