Multimodal Laser Treatment of Photodamaged Skin

NCT07789002 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 16-0302-163
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Photo-damage; Actinic Keratosis (AK)

Keywords

laser; photodamaged skin; IPL; non-ablative fractional laser; fractional laser; Thulium laser; UV damage

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 60

Secondary Outcomes (5)

• Transcriptomic response

  Baseline to Week 60

• Safety of interventions

  Baseline to Week 60

• Pain assessment

  Baseline to Week 60

• Patient satisfaction

  Baseline to Week 60

• Change in Actinic Keratosis Count

  Baseline to Week 60

Study Arms (2)

Multimodal treatment

EXPERIMENTAL

Multimodal treatment with 1927-nm thulium laser + 1550-nm non-ablative fractional laser (NAFL) + intense pulsed light (IPL)

Device: 1927-nm thulium laser; Device: 1550-nm Er:Glass laser; Device: Intense Pulsed Light

Control

NO INTERVENTION

No treatment

Interventions

1927-nm thulium laser DEVICE

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

Also known as: fractional laser

Multimodal treatment

1550-nm Er:Glass laser DEVICE

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

Also known as: non-ablative fractional laser

Multimodal treatment

Intense Pulsed Light DEVICE

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

Also known as: IPL

Multimodal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merete Haedersdal: lead

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Central Study Contacts

Aqella Rasul, MD

CONTACT

0045 71590063; aqella.rasul.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors will be reviewing and scoring the clinical photos after the study is completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD, DMSc

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)